Nardox - Natural Sleep Medication (Monograph)

Nardox - Sleep Aid Capsules

Nardox helps in inducing natural sleep and restores mental peace. It reduces anxiety, restlessness and aggressiveness. And the best part is, it has no side effects, hangover or sedation. It is safe and non habit forming.

Following herbs are used in ful in inducing natural sleep:

Nardostachys jatamansi
Valeriana wallichii
Acorus calamus
Tinospora cordifolia

Nardostachys jatamansi

It is reported to have tranquilizing properties as per Ayurveda. It has been used alone or in the combination with TAGAR (Valerian wallchii) to relieve the anxiety symptoms. The infusion of root is administered in hysteria, palpitation of heart & other nervous diseases like convulsion & epilepsy.

Valeriana wallichii

Roots & rhizomes of Valeriana wallichii are used as sedatives & tranquilizer for the treatment of nervousness & hysteria. Valepotriate the active constituents possess definite sedative & tranquilizing activity in mice, cat & human. The root extract can be used as a day time sedative. A study conducted in 30 patients with anxiety disorder. Valeriana wallichii in combination with other was found to be useful in relieving anxiety symptoms.

Acorus calamus

Acorus calamus contains an essential oil having tranquilizing & sedative properties. In ayurveda it is used as anti- epileptic, psychoactive drug & has been reported to cure insanity & possess depressant action.

Tinospora cordifolia

Tinospora cordifolia is used as a general tonic & as a adaptogenic.The root possesses anti stress properties. When clinically evaluated for the anti stress & general health tonic properties, moderate degree of behavioral disorders, anxiety, restlessness & mental disorder were significantly improved by Tinospora cordifolia.

Indication & uses:

* Sleep disturbance, Insomnia

* Emotional stress, Irritability

* Anxiety, Tension

* Nervousness, Palpitation

* Natural sleep aid

Monograph:

Ever since the philosopher Descartes has separated the transcendent mind from the mechanical operations of the body, science has been even more concerned with accurately resolving the body into its component parts. People have come to view all illness as primarily a malfunction of the mechanical parts

 

(i. e. body) and have lost sight of the importance of the psychological, social and environmental influences on health & illness, and of the extraordinary power of the mind to effect the body. Mood, attitude and belief can affect virtually every chronic illness.

Apparently disorders of (diseases affecting) mood, emotion and attitude i.e. neuropsychological disorders has implication on the entire human system.

ANXIETY

               

Anxiety, characterized by abnormal nervous tension and distortion of thinking, is not cardinal symptom of many psychiatric disorders, but also an almost inevitable component of many medical and surgical conditions. It is a universal human emotion, closely allied with appropriate fear and often serving psychologically adaptive purposes. An important clinical generalization is that anxiety is rather infrequently a “disease” in itself, although in truth the anxiety associated with many of the psycho-neurotic disorders, often seems to have an incomprehensible life of its own. Thereby emphasizing the necessity for anti-anxiety medications which can be frequently, appropriately and safely used for treating primary and secondary anxiety.

CURRENT ANTIANXIETY THERAPY:

The primary characteristics of anti-anxiety drugs in contrast to many other drugs that act on central nervous system, is that they alter the mental state and behavior in a predictable way.

While pharmacotherapy with anti-anxiety drugs does not cure mental disorders in the same sense that antibiotic cure infectious diseases, the available drugs do control most symptomatic manifestations, behavioral deviance and facilitate the patient’s tendency towards remission. Hence improves his/ her capacity for social, occupational and familial adjustment.

Anti-anxiety drugs, like other drugs used in psychiatry, can cause a wide range of adverse effects. Many physiological systems may be affected, but central nervous system (especially the higher cerebral functions) is particularly vulnerable. The most common of all adverse effects is over sedation and hangover. This is a serious problem while driving and while working in dangerous situations. Other major side effects are impairment of intellectual functions, behavioral and performance discrepancy, drowsiness and general apathy. Another major disadvantage of currently prescribed anti-anxiety drugs is development of drug tolerance, dependence and withdrawal symptoms like reflux anxiety, restlessness, agitation, insomnia, delirium, convulsions and hypertension.

The aforementioned disadvantages of currently prescribed anti- anxiety drugs necessitate the need to develop new and safer anti-anxiety drugs. In compliance with the same quest, Nirvana Wellness has formulated a new herbal product, NARDOX, as an effective Sleep-Aid.

NARDOX: AN IDEAL TRANQUILIZER.

NARDOX a herbal tranquilizer, is based on a balanced formula derived from Medhya Rasayana drugs of ancient Indian form of medicine- AYURVEDA. Each herb included herein has been reported to counteract the Anxiety State by tranquilizing the patient. They also improve the memory span and intelligence.

NARDOX, is an Herbal Sleep – Aid, has an edge over conventional antianxiety drugs, because:

Being a herbal preparation, it is safe and does not affect higher function.

It is devoid of any side effect like over sedation, hangover etc.

It does not produce drug tolerance, dependence and drug withdrawal symptoms.

Hence NARDOX can be very safely used to reduce anxiety, tension, irritability, palpitation and also to improve memory, thereby justifying the use of NARDOX as a “nervine tonic”. The various medicinal herbs included in the formulation, along with their common names are Nardostachys jatamansi (Jatamansi), Tinispora cordifolia (Gudduchi), Valeriana wallichii (Tagar) and Acorus calamus (Vacha).

The subsequent discussions provide a rationale for inclusion of each of the aforementioned herbs in the currently introduced formulation: -

NARDOSTACHYS JATAMANSI:

N. jatamansi (Fam: valerianacae), commonly known as Jatamansi. Charaka , Sushruta and Vagbhatta, the three ancient manuscripts of Ayurveda, has recommended Jatamansi most frequently in treatment of mental disorders as a sedative and tranquilizer. N. jatamansi contains essential oil – Jatamansone, a ketonic sesquiterpene as its major biologically active constituent. It also contains Jatamansic acid as one of its constituents.

PHARMACOLOGY AND CLINICAL TRIALS :

N. jatamansi has been universally known for its tranquilizing properties in the Indian system of medicine – Ayurveda. It has been used in Ayurveda, either alone or in combination with Valeriana jatamansi for treating various anxiety disorders. The infusion of roots is administered in hysteria, palpitation of heart and in various other nervous diseases like epilepsy and convulsions (Arora, 1965).

Jatamansone also exerted tranquilizing action in mice and monkey (Arora et al., 1962). The oil , also potentiated phenobarbital –induced narcosis in rats, reduced the conditional avoidance response in cats and reduced the rat brain serotonin content (Hamied et al ., 1962). The mode of action of Jatamansone is to reduce the brain levels of 5 hydroxytryptamine by impairing the biosynthesis of serotonin in the brain tissue (Arora et al .,1962).

In an open trial of 4 weeks in 25 patients with anxiety disorders, N. Jatamansi in combination with other herbal drugs was found to be useful in relieving the anxiety symptoms, wherein the onset of action was observed by the end of 2^nd week and the maximum response by the end of the 4^th week (Shah, et al., 1994). A double blind clinical trial conducted in 28 hyperkinetic children below 14 years of age for 11 months showed that jatamansone improved the behaviour significantly (Gupta et al., 1968). Jatamansone was also found to reduce the mental symptoms in the schizophrenic patients (Mahal et al., 1976).

            In Ayurveda, Jatamansi has been reported to improve intellect and memory. The root infusion can be used in treatment of menopausal symptoms and indigestion (Thakur et al ., 1989). Jatamansone also exhibited anti- emetic properties in dogs and reduced aggressiveness in monkeys (Rastogi et al., 1990).

TINOSPORA CORDIFOLIA:

T. cordifolia (Fam : Menispermaceae) commonly known as Guduchi. It has been reported to possess a wide range of therapeutic activity. It has been used in the traditional system of medicine as an Indian bitter. In Ayurveda, the drug is administered along with piper longum root , to prevent gastric degradation of food materials and to improve the digestion. It contains Tinosporin, Tinosporon, Cordifolide, Tinosporon and Tinosporine as its major biologically active

constituents. The leaves also contain octasanol and beta – sitosterol (Dixit et al., 1971; Kudrat – I –Khuda, 1964).

PHARMOCOLOGY AND CLINICAL TRIALS:

In Ayurveda, T. cordifolia categorised as “Rasayana” is used as a general tonic and as an adaptogenic. The root possesses anti stress properties (WOI, 1976; Thatte and Dahanukar, 1989). Mortality rate in E. coli induced peritonitis was significantly reduced with T. cordifolia treatment (Dahanukar et al., 1988 ; Rage et al., 1989).

Sheth et al., (1991) and Sharan et al., (1991) have clinically evaluated the antistress and general health tonic properties of T. cordifolia wherein moderate degree of behavioral disorders and mental disorders were significantly improved. Increase in IQ levels was also significant. T. cordifolia also protected cholestatic patients against E. coli infection (Thatte et al., 1989).

The root possess antileprotic and anti- malarial activity (WOI,1976). The extracts of T. cordifolia showed hepatoprotective effect against carbon tetrachloride induced hepatotoxicity (peer et al., 1989).

3). VALERIANA WALLICHII:

                V. wallichii (Fam: Valerianaceae) commonly known as Tagar. In Ayurveda, the extracts of V. wallichii have been cited for its neuroleptic and sedative properties. V. wallichii contains valepotriates (triesters of polyhydroxy alcohol with valeric, isovaleric and isocaproic acid) as its active constituents. The other constituents identified are archidic acid, haspertonic acid and caproic acid.

PHARMACOLOGY AND CLINICAL TRIALS:

               

Roots and rhizomes of V. wallichii are used as sedative and tranquilizer for the treatment of hysteria, nervous unrest, hypochondriasis and similar emotional states. Valepotriates were found to possess definite sedative and tranquilizing activity in mice, cats and humans. Valepotriates has also been reported to improve coordination and diminish restlessness, anxiety and aggressiveness in animals without adverse effect on reactivity (Klaus et al., 1969). The hypnotic effect in mice was antagonized by a mixture of Valepotriates (100 mg/ kg orally) (Klaus et al., 1969). It also exerted sedative, spasmolytic, CNS depressant and antitumour effect (Sharma et al., 1989). The root extract can be used as day- time sedative since it does not have synergy with alcohol and doesn’t slow down the reflexive response (Hobbs, 1990; Monograph, German Min. Health, 1989).

           

Twenty epileptic patients were tested for cognitive functions following sodium valproiate monotherapy. Progressive improvement in attention, intelligence, immediate recall and visuospatial functions, with no charge in orientation and recent and remote memory was observed (Jha et al., 1992). In another open trial of 4 weeks conducted in 30 patients with anxiety disorders, V. wallichii in combination with other herbal drugs was found to be useful in relieving anxiety symptoms , wherein onset of effect and maximal effect was observed by the end of 2^nd  and 4^th week respectively. Long term treatment upto 12 weeks improved the efficacy of the drug quantitatively, but was found to be devoid of any side effects (Shah et al ., 1994).

4). ACORUS CALAMUS:

A.calamus (Fam: Araceae) commonly known as Vacha. The plant extracts have been extensively used in the traditional Indian system of medicine as a sedative, in the treatment of epilepsy, insanity, and as a tranquilizer. It contain the two isomeric substances, Asarone and B- Asarone as its major, biologically active chemical constituent.

PHARMACOLOGY AND CLINICAL TRIALS:

A.calamus essential oil was found to possess tranquilizing and sedative properties comparable to that of chlorpromazine and reserpine (Handa, 1994). In Ayurveda, A. ocalamus is used as antiepileptic , psychoactive drug and has been reported to cure insanity, promote intellect and intelligence. The aqueous and alcoholic root extracts exhibits depressant action (Bose et al., 1960). The extracts are also used in treatment of petitmal epilepsy (Martis et al., 1991). Essential oils of A. calamus also showed sedative and tranquilizing action in rats, cats and dogs (Rastogi et al., 1965; Sharma et al., 1961).

Asarone and B- Asarone has been reported to potentiate the hypnotic activity of anaesthetic agents, produce significant reduction in rectal temperatures in mice and shows anti- cholinergic action in mice (Sharma et al., 1961; Rastogi et al., 1962).

           

In an open trial of 4 weeks A. calamus in a composite formulation was reported to be useful in relieving anxiety symptoms in 30 patients with anxiety disorders. In long term A. calamus (for 12 weeks) showed quantitative improvement in alleviating anxiety disorders without producing any side effects (Shah et al., 1994).

           

The essential oils also showed smooth muscle relaxant properties as well as antispasmodic action against various spasmogens (Dhalla et al., 1962). It is also useful in preventing electrically induced convulsions in hind limbs of the rats (Madan et al., 1960). It blocks the neuromuscular junctions, both pre and post synoptically by interfering with the calcium and magnesium ion effects respectively (Panchal et al., 1989). Both asarone and B- asarone showed cardiac depressant activity, along with stoppage of frog heart in diastole and moderate hypotensive action in anaesthesised dogs. (Rastogi et al., 1990).

REFERENCES:

Arora R. B., (1965).ICMR New Delhi.

Arora R. B,.Singh M. and Chandra K., (1962). Life Sci, 6: 225.

Bose B. S., Vijayavargiya R.,Saiji A. Q. and Sharma S. K.  (1960). J. Amer. Pharm. Ass., 49 :32.

Dahanukar S. A., Pai P. M., Thatte U. M., Dube B. L. and Dasi R. G., (1989). Indian J. Gastroenterol ., 7 (1) : 21.

Dhalla N. S. and Bhattacharya I. S.,(1968). Arch. Int, Pharmacodyn. 172 : 356.

Dixit S. N. and Khosa R. L.,(1971). Indian J. Appl. Chem., 34 : 46.

Gupta B. D. and Virmani V.,(1968). Neurology (India), 16 : 168.

Hamied K. A., Bakshi V. M. and Aghara L. M.,(1962). J. Sci. Ind. Res., 21c : 100.

Handa S. S., (1994). Pharma Times, 3 : 17- 25.

Hobbs C.,(1989). Herbalgram, 21 : 19-34.

Jha S., Nag D., Shukla R., Saxena R. C. Trivedi J. K. and Kar A. M., (1992). Indian J. Pharmacol., 24 : 219-222.

Klaus  W., Von Eicckstedt. and Rahman S., (1969). Arzneim. Forsch, 19 : 316.

Madan  B. R., Arora R. B. and Kapila K., (1960). Arch. Int. Pharmacodyn., 1224 : 201.

Mahal R. S., Chaturvedi D.D., Thomas K. M., Senapati H. M., Rama M. G. and Murthy, N. N., (1976). Indian J. Psyc., 18 : 283.

Martis G., Rao A. and Karanth K, S.,(1991). ,itoterapia, 62 : 331- 337.

Panchal G. M., Venkatakrishna R., Bhatt K.,Vajpayee S. and Doctor R. B., (1989). Indian J. Exp. Biol., 27(6) : 561 – 567.

Peer F. and Sharma M. C., (1989). Indian J. Vet. Med., 9(2) : 15.

Qudrat –I-khuda M., Khaleque A. and Roy N.,(1964). Chem. Abstr., 61 : 12331.

Rastogi R. P. and Mehrotra B. N., (1969). In : Compendium of Indian Medicinal Plants, Vol. 1. (1960 – 1969). CSIR and PID, New Delhi (India) pp 8 –9, 286

Rege N. N., Nazareth H. M., Bapat R. D. and Dahanukar S. A., Indian J. Med. Res., 90 : 478.

Shah L. P., Hanumantha K. and Seena B.,(1994). Update Ayurveda, Pub. Ayurveda Research Centre, KEM Hospital, Mumbai, India. pp 55.

Sharan R. and Khare R.,1991). Probe, 31(1) : 12.

Sharma J. D., Dandiya P. C., Baxter R. M., and Kandel S. I., (1961). Nature, 192 : 1299.

Sheth S. C., Tibrewala N. S., Pai P. M., Dube B. L. and Dasi R. G., (1991). Probe, 30 (3) : 222.

Thakur R. S., Puri H. S. and Hussian A., (1989). Major Medicinal Plants of India. Pub. CIMAP. India. pp 361.

Thatte U. M. and Dahanukar S. A., (1989). Phytother. Res., 3 (2) : 43.

Anon. (1976). Wealth of India (Raw Materials), Vol. X. CSIR, New Delhi, India. pp 251.

Anon.(1985) Monographs for Phytomedicines., Valerian Commission E. German Ministry of Health. Bonn. Germany

 

Liponix - Weight Loss Supplement (Monograph)

Liponix - Weight Loss Supplement

Each capsule of Liponix contains aqueous extracts of:


Commiphora mukul:
Commiphora mukul has been established as a potent hypolipidemic agent . Various studies identify guggulsterone approximately constitute 2% of the gum resin as its active ingredients. A number of pharmacological & clinical trials have proven its efficacy. It has been found to lower serum cholesterol, triglycerides, phospholipids & total lipids significantly without causing any hazardous side effects.

Terminelia arjuna:
Terminelia arjuna has been used to tone up the cardiac function. It is well known for its hypolipidemic & hypocholesterolemic properties. In an experimental study it was noted that the & hypocholesterolemic rabbit receiving Terminelia Arjuna treatment showed more substantial reduction in total cholesterol & triglycerides & elevation in HDL- cholesterol than the hypocholesterolemic controlled ones.

Inula racemosa:
Inula racemosa has been used for its hypolipidemic activities. In a clinical trial, Inula racemosa based formulation was given to 250 patients having coronary Heart Disease, this treatment showed marked influence on various fraction of the body composition. Total body fat exhibited declining trend & significant reduction in cholesterol, triglycerides & total lipid level was observed. The result substantiates efficacy of the test drug as a hypolipidemic agent.

Embelica ribes:
Embelica ribes is a time tested herb that helps to reduce excess fats & regulate the metabolic activities in the body. In a pharmacological trial, Embelin, an active constituent of Embelica ribes was given to the albino rats at a dose of 20 mg/kg for 15-30 days. At the end of the treatment alteration of the enzyme activities as well as significant decrease in the tissue weight and organ were observed.

Indications:

• Adult obesity
• Hyperlipidemia
• Hypertriglyceridemia

Monograph: 

Obesity clearly poses a danger to health, having been associated with numerous health problems including heart disease, high blood pressure, diabetes and certain types of cancer. It has also been shown to result in a decreased life span for both, men and women, diets for weight loss have been shown to be ineffective and even damaging to health.

Obesity is indicated by an abnormally high proportion of body fat. Although it is commonly assumed that obesity is due to overeating, there is, in fact a complex interaction between one’s culture, environment, exercise habits and eating styles, as well as one’s genetic makeup and biochemical individuality.

There are cases where excess weight is gained because of conditions such as food allergies and nutrition deficiencies. Other times weight gain may be due to a sluggish metabolism, chemical toxicity, insulin imbalance and excessive dieting. It can take place even as a result of impaired thermogenesis.

Metabolic rate can be understood as being the rate by which the body utilizes energy. The basal metabolic rate (BMR), which varies tremendously between individuals, is the minimum amount of energy needed to maintain normal body functions. Ages, sex, body size, type of food and fat to muscle ratio are all factors that influence how efficiently an individual burns calories. It has been found that thin people have higher metabolic rates and burn calories at a much faster rate than the obese one.

The body contains two types of fat tissue- white adipose tissue (WAT) which stores fat and brown adipose tissue (BAT) which burns up fat to produce heat in a process called termogenesis. Evidence indicates that an impairment of the termogenesis system in BAT may lead to obesity. If fat from the diet is not burned up by BAT, it is stored as fat in WAT, thus contributing to excess body weight.

Insulin allows the body to utilize glucose and carbohydrates. Factors such as genetic predisposition, eating habits and stress may interfere with glucose and carbohydrate utilization, leading to a condition called glucose intolerance, normally insulin signals the body to stop eating, but if a person has chronically elevated glucose levels due to inefficient insulin, he may eat more.

When an overweight person becomes more obese, the insulin problem becomes worse as well, because the individual becomes more unresponsive to the action of insulin. In such a person, the simple carbohydrates are initiating the release of increasing amounts of insulin, but the body can not use it efficiently. Apparently the insulin receptors on their body cells are blocked from doing their function. This prevents insulin from stimulating the transfer of glucose to the cells to give them energy, which explains why the overweight people feel tired so often. Since the insulin is not converting the glucose to energy, more glucose is then moved into the fat cells to create more fat. Thus worsening the matter.

The imbalance in insulin hormone functioning may lead to abnormality or decreased efficiency in the activity of other related and dependent hormones. Ultimately, either insulin receptors or the pancreas itself becomes exhausted, in which case diabetes can result.

The excess insulin in overweight people can lead to other problems and complications such as:

-          Increased salt and water retention

-          Sleep disorders caused by insulin interference with the neurotransmitters

-          The increased production of LDL (Low Density Lipoprotein) by the liver due to insulin stimulation, which is an increased risk for cardiovascular disorders.

-          Interference with the thyroid hormone, thyroxin thereby aggravating low metabolism

-          Decreased cell wall permeability, which can cause an increase in cell size.

-          Hypoglycemia, hunger and a further craving for simple carbohydrates.

WEIGHT MANAGEMENT

Low calorie diets and exercise have been the typical solution to losing weight. Unfortunately, the weight lost by dieters is almost always regained. As a result, many dieters fall into the trap of a repetitive cycle of weight loss and gain. The people always overlook the fact: It does not matter how much a person eats, but what a person eats is important. Whenever the body is deprived of food, whether from famine or dieting, it ensures survival by decreasing the metabolic rate in order to compensate for fewer calories. Dieting not only slows down the metabolic enzymes, but also leads to the emaciation of toxic fats in tissues and fatigue.The more rapid the weight loss, the higher risk of heart complications from muscle loss as well. For an obese person, it is essential to gain muscle mass and increase the amount of fat burning tissue. Only the diet, that provides these means, can be beneficial in such cases.

Weight loss medication work by either stimulating the nervous system or by suppressing appetite all weight loss drugs are associated with some side- effects; such as adverse effects on heart and blood pressure, an increased level of toxic fat in the tissues and also a variety of degenerative diseases.

Nirvana Wellness offers a safe and natural solution for obesity: Liponix.

Liponix helps to improve basal metabolic rate and burn body fat.Thus prevailing obesity.

Liponix overcomes the urge of the body for excess food intake. It normalizes the psychosomatic parameters leading to obesity.

Liponix helps to restore normal body functions involved in energy metabolism.

Commiphora mukul, Inula racemosa and Terminalia Arjuna, the ingredients of Liponix, have highly potent hypolipidemic and hypocholasterolaemic activities.

Liponix is a combination of following herbs:

Commiphora mukul (Guggul), Terminalia arjuna(Arjuna), Inula racemosa (Pushkaramool) and Embelia ribes(Vidanga).

1)    COMMIPHORA MUKUL (GUGGUL)

C. mukul is commonly known as Guggul or Indian Olebanum. It is well known for its anti- inflammatory, analgesic and anti- rheumatic properties. Now, it has been established as a potent hypolipidemic agent.Various studies identity (Z) – guggulsterone and (E) - guggulsterone (together constituting approximately 2% of the gum resin) as its active ingredient.

PHARMACOLOGICAL AND CLINICAL TRIALS

Following reports, quoted by Satyavati prove the efficacy of C. mukul as a hypolipidemic agent.

The petrol soluble fraction and the alcoholic extracts of C. mukul were reported to lower the serum cholesterol in hypercholesterolemic chicks. The alcoholic extract of C. mukul exhibited a similar hypercholesterolemic effect in rabbits and domestic pigs. This extract was also found to lower serum cholesterol in triton treated rats.

The petroleum ether extract (fraction A) and ethylacetate extract (fraction B) of gum guggul reduced serum cholesterol, triglycerides and total lipids in hyperlipidaemic chicks.

Fraction A was found to reduce serum cholesterol, triglycerides, total lipids and phospholipids in estrogen induced hyperlipidaemia in chicks. It also revealed a marked hypolipidemic effect Mongolian gerbils, in which hyperlipidemia were induced by diet.

In the chicks, rendered hyperlipidemic by a high fat diet, the gum resin (3 g/kg) given for 1 month in the diet, lowered serum cholesterol and triglycerides and also reversed, to some extent, the atherosclerotic process in the aorta.

In triton induced hyperlipidaemia in presbytis monkeys, the steroid fraction of guggul lowered total cholesterol (by 60.5%), triglycerides (by 39.4%), phosopholipids and also non-esterified fatty acids (by 42.9%) as compared to clofibrate which lowered the same parameters by 47.6%, 51.0%, 41.7% and 31.7%, respectively. The steroid fraction of guggul also lowered LDL cholesterol (76.1%) and VLDL cholesterol (40.6%) remarkably. The ratio of HDL cholesterol to total cholesterol in the steroid treated monkeys was significantly higher at all intervals, as compared with the initial values.

In hyperlipidemic rats and monkeys, a standard ethyl acetate extract led to significant changes in the lipoprotein profile by reducing the serum cholesterol and triglycerides and altering the ratio of HDL to LDL cholesterol apart from regression of atheromatous lesions. This extract also afforded partial protection against isoproternol induced myocardial necrosis in rats.

Studies on the mechanism of hypolipidemic action

The study on c. mukul had suggested an anion exchange property with bile acid sequestration leading to enhanced excretion of cholesterol as one of the possible mechanisms of its hypolipidemic action.

Nityanand et al.Have reported slight inhibition of cholesterol biosynthesis in rats by the alcoholic extract, as compared to Atromid (p- chlorophenoxyisobutyrate) in liver slices, by acetate incorporation. Among the various fractions of C. mukul tested in vitro for inhibition of acetate incorporation into cholesterol, the ethylacetate extract, petrol ether extract and the steroid demonstrated inhabitation, the steroid fraction revealing maximum inhibition.

Kinetic studies on the rates of cholesterol turnover in Wistar rats revealed an enhanced rate of removal of cholesterol by fraction of A of C. mukul petrol ether extract, as well as by clofibrate. Fraction A also increased the rate of removal of cholesterol, possibly through the gut. In this respect, the effect of fraction A was similar to that of clofibrate.

The ketosteroid of Guggle gum (3 mg/kg given for 1 month) lowered the serum cholesterol, phospholipids and triglycerides in male white leghorn chicks. The mode of action suggested is rapid degradation of cholesterol by activation of the thyroid.

The effect of C. mukul extract on the levels of dopamine beta- hydroxylase and catecholamine activity of normal and cholesterol fed rabbit tissues was studied. The catecholamine levels and enzyme activity were found to be decreased in cholesterol fed rabbits (500 mg/kg). The extract also helped to recover the decrease in catecholamine biosynthesis. This is supposed to be one of the possible mechanisms of hypolipidemic action of C. mukul.

An indigenous preparation, having C. mukul as the only ingredient, was subjected to extensive pre- clinical studies. The drug did not demonstrate any adverse action on liver function, blood urea or any haematological parameters; when administered in a dose of 400 mg thrice a day for 4 weeks. It was found to be devoid of any hormonal, central nervous system, cardiovascular or diuretic effects in rats. It showed no adverse effects in toxicity and teratogenic studies over a period of 6 months, in rats, monkeys and beagles.

A double blind cross- over trial of C. mukul (fraction A) was conducted by Kotiyal et al., (1979) in 48 patients of hypercholesterolemia, in the age group of 25-70 years. One group was treated with placebo and the other with C. mukul fraction A in a dose of 1 capsule (containing 0.5 gm of the drug) thrice a day. Results showed a highly significant reduction in serum cholesterol. Total lipids and triglycerides as well as nonesterified fatty acids also showed a marked reduction after the drug administration. . Statistical analysis before and after the placebo administration showed that it has no significant effect on the above mentioned parameters. These results prove the efficacy of Guggul as a non- toxic and safe indigenous drug in Hypercholesterolaemia.

Clinical trials conducted at B. H. U., Varanasi, showed that C. mukul administered in a dose of 2 gm, thrice a day, in patients with obesity and/ or hyperlipidemia reduced their serum cholesterol and phospholipid levels as well as their body weight significantly.

Fraction A of C. mukul 1.0 gm/ day was administered for 12 weeks to 20 patients having hyperlipoproteinaemia. It markedly lowered serum cholesterol, triglycerides, phospholipids and total liquids. The hypolipidemic effect of C. mukul was better than that of clofibrate administered to 20 patients.

In a double blind cross over study with placebo on 60 obese patients, crude C. mukul (4 gm in three divided doses administered for 4 weeks) revealed a significant fall in serum total lipids, cholesterol, triglycerides and beta- lipoproteins while no changes were observed in these parameters with placebo.

A double blind clinical trial on 3 groups of 40 obese patients was conducted. One group was treated with crude C. mukul (12 gm thrice daily), another with fraction A petroleum ether extract (0.5 gm/ thrice daily) and the third with placebo, for 21 days. The significant lowering of serum cholesterol by crude drug and fraction A was observed from the tenth day onwards, which was further decreased by day 21.

In a clinical study on C. mukul (1.5 gm/day) compared with clofibrate (2 gm/day) over a period of 75 weeks in 51 and 10 patients of hyperlipoproteinaemia, respectively. Both drugs showed highly significant lipid lowering effect on serum cholesterol, as well as triglycerides, at all periods of observation (i.e., at an interval of 10 weeks) up to 75 weeks. In three patients with xanthomatosis treated with fraction A, there was a gradual, but complete resolution of the lesions in about 40 weeks. With clofibrate, in only one of the three patients of xanthomatosis was there complete resolution.

In another clinical trial, 47 patients were first given placebo for 1 month, followed by administration of 2 gm Guggle gum thrice a day for 3 months. A significant fall in serum cholesterol was reported at monthly intervals until 3 months after cessation of Guggle gum administration. Serum triglycerides showed reduction only after 2 months of Guggle administration and the reduction was maintained during 3 months follow- up. Serum beta- lipoproteins revealed significant decrease only after 3 months therapy and during 3 months follow- up.

A controlled clinical trial was conducted on 62 obese patients (10% overweight for height, age and sex). 35 of them received 1.5 gm fraction A of C. mukul in three divided doses, while 27 patients received placebo for 4 weeks. There was a significant reduction in serum cholesterol and triglycerides levels in the group treated with fraction A. No toxic effects or side effects were observed during the trial.

An open trial was conducted to evaluate the efficacy of C. mukul in 30 patients of Hyperlipidaemia, divided into 3 groups, of 10 each. Fraction A of C. mukul (300mg B.I.D.) was administered to one group, Garlic extract (1 garlic pearl B.I.D.) to second group and Clofibrate (500 mg B.I.D.) to third group. The treatment was continued for 1 month, to all the groups. Maximum decrease in serum cholesterol, triglycerides and LDL cholestrol levels was found in the group receiving C. mukul.

Motwani studied healthy individuals and the patients having coronary heart disease. He found that serum cholesterol and triglyceride levels were reduced by the administration of C. mukul when the initial serum cholesterol levels were higher than 220 mg% in both subjects.

In a cross- over clinical trial of six months duration, C. mukul (purified according to the Ayurvedic method) was administered (1 gm thrice a day) for 3 months, followed by placebo treatment for 1 month, to 51 male patients with hypercholesterolaemia. A significant fall in serum cholesterol and beta- lipoproteins marked at the end of 1 month of guggle gum administration persisted 3 months after discontinuation of the drug. In this study, a steady trend for decrease in the body weight was marked.

A double blind clinical trial was carried out with fraction A of Guggul gum in 51 patients of obesity and compared to 34 obese patients treated with placebo. First group was given 300-mg capsules of the drug three times a day for 12 weeks. This group showed a significant reduction in serum cholesterol and triglycerides after 4 weeks of the treatment, which persisted up to 12 weeks. The triceps thickness was reduced significantly after 8 and 12 weeks in this group.

Hypocholesterolemic and hypolipidemic action of gum guggul was evaluated in 25 patients having Coronary artery disease (diagnosed on the basis of previous history of myocardial infarction, ECG findings, Serum cholesterol and triglycerides). Purified C.mukul was administered in the form of pills in a dose of 12- 16-gm/ day in four divided doses for 3 months. The drug not only reduced the serum cholesterol and triglyceride levels but also reversed ECG abnormalities in 16 patients. There was also a reduction in body weight at a rate of 1 kg/ month (Upadhyaya et al., 1976).

2)    TERMINALIA ARJUNA (ARJUNA)

T. arjuna. Commonly called as Arjuna, is well known for its hypolipidemic and hypocholesterolemic activities. It has been used to tone up cardiac functions since hundreds of years.

PHARMACOLOGICAL AND CLINICAL TRIALS

Chaturvedi (1973) had reported that alcoholic decoction of T. Arjuna significantly increases euglobin lysis time, prolongs prothrombin time and lowers the serum cholesterol levels in ischaemic heart disease patients. In this study , comprising of 30 coronary artery disease patients, T. arjuna was found to modify various known coronary risk factors like obesity , hypertension, diabetes mallitus and circulating catecholamines. No side effects were observed during this study.

In an experimental study, Tiwari et al ., (1990) noted hypercholesterolemic more significant reduction in total cholesterol and triglycerides and elevation in HDL- cholesterol than hypercholesterolemic control rabbits.

Dwivedi et al ., (1989) had studied the effect of T. arjuna in 15 stable angina cases and found it effective in reducing intensity and frequency of angina pectoris and improvement in effort tolerance. The drug lowered systolic blood pressure and body mass index and increased HDL- cholesterol. It did not cause any deleterious effects on the kidney or liver function. It has been observed to increase PGE₂, like activity following isoproterenol ischaemia in rabbits.

3)    INULA RACEMOSA (PUSHKARMOOLA)

It is commonly known as Pushkarmoola. It has been used for its hypolipidemic activities as described in ancient Ayurvedic literature.

PHARMACOLOGICAL AND CLINICAL TRIALS

Patel. (1981) had investigated biochemical effect of 1.racemosa on isoprenaline induced changes in rat’s serum glutamic oxalacetate transaminase, lactic dehydrogenase and creatinine phosphokinase and found propranolol like beneficial effect in prevention of coronary ischaemia.

An indigenous Ayurvedic preparation, having I. racemosa as the main ingredient, was studied clinically by Singh et al., (1993). It was given to 200 patients having ischaemic heart disease. At the end of the treatment, significant reduction in cholesterol, triglycerides and total lipid levels was observed. The result substantiates efficacy of the test drug as a hypolipidemic agent.

An Ayurvedic formulation, having I. racemosa as chief ingredient, was evaluated by Dubey et al., (1995). Administration of this formulation to 250 cases of coronary heart disease showed marked influence on various fractions of the body composition. Total body fat exhibited declining trend while body mass index (fat free lean body mass) did not show any alteration following changes. The drug did not cause any adverse side effects.

Suryamani , (1980) had reported that I. recemosa exhibits hypoglycaemic effect in diabetes and experimental diabetic rabbits.

4)    EMBELIA RIBES (VIDANG)

Vidanga is a time-tested herb that helps to reduce excess fat and regulate the metabolic activities in the body. It has been advised to treat ‘Medoroga’ (Meda- Fats) in ancient Ayurvedic literature: Charak Samhita, Sushrut Samhita, etc.

PHARMACOLOGICAL AND CLINICAL TRIALS

Gupta et al.,(1990 , 1991) conducted a trial to study inhibition of carbohydrate metabolism and reversibility of the effects of embelin, an active constituent of E. ribes. The albino rats were given 20 mg/ kg subcutaneously for 15-30 days. Alterations of the enzyme activities of glycolysis, lipogenesis, kreb’s cycle, NAD- and NADP- dependent enzymes, transaminases and phosphatases were noted on this treatment. Marked changes were noted in the levels of glycogen, protein, nucleic acid and certain carbohydrate constituents. Significant decrease in the tissue weight as well as organ weight was also observed

.

REFERENCES

Akhtar Husain,Virmani, O. P., Popli, S. P., Misra, L. N., Gupta, M. M., Srivastava, G. N., Abraham, Z. and Singh, A. K., (1992).Dictionary of Indian Medicinal Plants, Central Institute of Medicinal and Aromatic Plants, Lucknow, India.

Akhtar Husain, Thakur, R. S. and Puri, H. S., (1989) Major Medicinal Plants of India , Page: 208- 213.Central Institute of Medicinal and Plants, Lucknow, India.

Bhavaprakash Nighantu, part 1, Ed. Misra, B. S. and Vaisya,(1990). 7^th Edition, page: 151.Chaukhamba Sanskrit Sansthan, Varanasi, India.

Chopra, D., (1994). Alternative Medicine, Future Medicine Publishing Inc.,WashingtonPp. 762

Dahanukar.S., Sharma, S. and Karandikar , S., (1983). Indian Drugs July, 1983, page 305- 411

Dubey G. P., Singh, S. and Mishra , A. K. Seminar on Research in Ayurveda and Siddha, CCRAS , New Delhi, 20- 22 March. 1995.

Duwiejua , M., Zeitlin, I. J., Waterman P. G., Chapman , J., Mhango, G. J. and Provan, G. J., (1993). Planta Medica, 59 (1): 12- 16.

Dwivedi , S., (1980). M. D. (Ayu.) Thesis, B. H. U., Varanasi, India.

Dwivedi , S., Chansouria, J. P. N., Somani, P. N. and Udupa, K. N., (1989). Alternative Medicine, 3 : 115.

Gupta , S., Kanwar, U and Sanyal, S. N., (1991). Fitoterapia, 62 (5) : 419.

Kotiyal , J. P., Bisht, D. B. and Singh, D. S., (1979). J. Res. Indian Med., 14 (2) : 11-16.