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Caralluma fimbriata _Roxb_

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					RONALD M. LAWRENCE, M.D.

Slimaluma - Caralluma Fimbriata Extract A Clinically Proven Herbal Alternative in the Management of Obesity Ronald. M. Lawrence and Suneeta Choudhary Introduction. Obesity is a potentially fatal disease. A panel of experts convened by WHO stated on 12 June 1997 that “obesity's impact is so diverse and extreme that it should now be regarded as one of the greatest neglected public health problems of our time. It has an impact on health, which may well prove to be as great as that of smoking” (World Health Organisation, 1997). Obesity is no longer regarded as an aesthetic issue or merely as a health problem. It is now medically viewed as a full-fledged disease that is reaching epidemic proportions across the developed world. It is a direct causal contributor to many diseases and exacerbates numerous others. Among these are five of the leading causes of death in the industrialized world: stroke, atherosclerosis, cardiovascular disease, diabetes and cancer. Obesity – Clinical Impact. Obesity has a measurable and dramatic effect on several vital body parameters. Lipid Profile : Obesity increases blood cholesterol levels. Specifically, LDL ( the “bad” cholesterol) has been shown to increase dramatically with progressive weight gain. LDL has been implicated in plaque formation in blood vessels, leading to atherosclerosis, hardening of blood vessels and consequently, heart attacks and cerebral stroke. Blood Sugar : Uncontrolled weight gain is the primary cause for Type 2 diabetes and Syndrome X. This syndrome is characterized by elevated cholesterol levels, high blood sugar and insulin resistance. Diabetes is regarded as one of the top three killer diseases in the developed world, the other two being hypertension and cancer. Blood Pressure : That obesity can cause hypertension is well established. Hypertension is the developed world’s number one killer ailment. It can, and does, cause heart attacks, heart failure, stroke, renal failure and cerebral hemorrhage.

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RONALD M. LAWRENCE, M.D. Musculo-Skeletal System : Obesity leads to increased wear and tear on weight-bearing joints, particularly the knees, hips and ankles. The result is progressive osteoarthritis, fibromyalgia and aggravation of osteoporosis. Vascular System and Blood Circulation : Obesity is a causative factor in the development of varicose veins and serious circulatory ailments like deep vein thrombosis and thrombophlebitis. In addition to the physiological effects obesity has on the human system, there are psychological disorders that can be blamed on obesity. Clinical depression, social phobias and eating disorders like bulimia and anorexia nervosa have their origins in distorted self-image caused by obesity. Obviously then, there is strong clinical need for effective therapeutic options for the treatment of obesity. Conventional Pharmaceutical Options. These include: Lipase Inhibitors : (Orlistat / Xenical ) - These work by inhibiting the absorption of consumed fat. Patient compliance is a serious consideration with lipase inhibitors, because of the way such drugs work. Several gastrointestinal side-effects occur. Uncontrollable gas and oily or fatty stools have been reported. Patients on Orlistat frequently complain of an increased number of bowel movements, oily spotting between bowel movements, bowel urgency , inability to control bowel movements and absorption of fat-soluble vitamins. Appetite Suppressants / CNS Stimulants : ( Phentermine, Ephedrine) - These drugs act by modifying neurotransmitter levels, specifically catecholamines and serotonin. Unacceptable side effects occur as a consequence of altered neurotransmitter function. These include increased heart rate, hypertension, anxiety, mood alterations, diaphoresis, dizziness, swelling of extremities, dryness of mouth, constipation and insomnia. Ephedra, in particular, has been implicated in patient deaths and has been withdrawn by the USFDA. Thermogenic Drugs : These drugs increase BMR ( basal metabolic rate) by altering thyroid function. Such drugs are not regarded as safe and can be used only under strict medical supervision. The consequences of modifying thyroid function can be serious. Clearly, conventional pharmaceutical drugs are limited in the benefits they can offer to obese patients.

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RONALD M. LAWRENCE, M.D. Caralluma Fimbriata – A Safe Herbal Alternative The herbal biodiversity of the Indian sub-continent is perhaps unmatched anywhere else in the world. India is home to approximately 45,000 plant species, only a few thousand of which have been documented. Caralluma Fimbriata is a succulent, edible cactus that grows across India. It has been in use since centuries in India as a vegetable and famine food. It is part of the food-chain in semi-arid regions of India. It is commonly used as a vegetable in semi-arid regions of India. It is eaten raw or cooked with spices, it is also used in pickles and chutneys. Indian tribals are known to chew chunks of C. Fimbriata to suppress hunger when on a day’s hunt. The cactus is used by the labor class in South India to suppress appetite and enhance endurance. A Standardized Extract of Caralluma Fimbriata. A standardized extract of Caralluma Fimbriata was developed in India be Gencor and since the past two years, it has been extensively studied for its use in appetite suppression leading to clinically significant weight loss. Clinical Trials and Toxicity Studies. Two independent clinical trials were done on Gencor’s Caralluma Fimbriata Extract- SLIMALUMA®. 1.] Clinical Trial at Division of Nutrition, St John’s National Academy of Health Sciences, India. Gencor’s Caralluma Fimbriata Extract underwent a clinical trial at the Division of Nutrition, St John’s National Academy of Health Sciences, Bangalore India during January to August 2003. This trial was a classical, double-blind, randomized, placebo controlled trial on 62 subjects. The trial was conducted as per OECD guidelines on clinical trials, and in accordance with these guidelines, it was under the supervision of the Ethics Review Board of St John’s Medical College, Bangalore. Subjects recruited: 62 Dropouts : 12 Subjects on placebo : 25 Subjects on active medicine : 25 Duration of the project : January -August 2003 Time points -Visit 1 (initial) Visit 2 (after 1 month) Visit 3(after 2 months) Dose : One capsule containing 500 mg SLIMALUMA® extract, one hour before major meal.

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RONALD M. LAWRENCE, M.D. Results from this clinical trial were subjected to rigorous statistical analysis, using statistical tests are the international norms and approved for doubleblind clinical trials. The summary of analysis is presented below. Statistically significant differences between time points were seen in the active group for the parameters of body weight, body mass index, waist circumference, hip circumference, body fat, blood pressure and hunger levels Body Weight : Active Group : There was a statistically significant decrease in body weight in the active group between all time points. Placebo Group : Although the weight came down in the placebo group, it was not statistically significant. Body to Mass Index (BMI) : Active Group : There was a statistically significant decrease in the body mass index in the active group between all time points. Placebo Group : There was no statistically significant change in the body mass index for the placebo group. Waist Circumference : Active Group : There was a statistically significant decrease in waist circumference in the active group between all time points. Placebo Group : There was no significant change in the waist circumference for the placebo group between any of the time points. Hip Circumference : Active Group : Statistically significant reductions were observed in the hip circumference. Placebo Group : There was a statistically significant decrease in the hip circumference of the placebo group between visit 1 & 2, while there was no difference between any of the other time points. Fat Loss : Active Group : There was a statistically significant decrease in the body fat (expressed in kgs) in the active group of subjects between visit 1 & 2, and visit 1 &3. Placebo Group : There was no statistically significant change in the body fat of the placebo group between any of the time points.

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RONALD M. LAWRENCE, M.D.

Hunger Level : Active Group : There was a statistically significant decrease in the hunger level in the active group. Placebo Group : There was no statistically significant change in the hunger levels in the placebo group. Between Group Trends: There was a statistically significant difference in change in hunger levels between the active and placebo group. Adverse Effects : Adverse effects noted were gastro-intestinal in nature and were reported by both active and placebo groups. These included acidity (moderate), constipation (mild) and flatulence (mild to moderate). These effects subsided within a week after commencement. No adverse effects were noted on other systemic functions. No changes in ECG were noted. No sympathomimetic effects were noted. Changes in Basal Metabolic Rate were not investigated.

2.] Clinical Trial at Western Geriatric Research Institute, LA, USA. This trial was done under my supervision on 26 patients and it followed the same double-blind format used in the earlier clinical trial. Subjects recruited: 26 Dropouts : 02 Subjects on placebo : 07 Subjects on active medicine : 19 Duration of the project : Four weeks Dose : One capsule containing 500 mg SLIMALUMA® extract, 30 minutes hour before major meal. Our subjects were taken from two active practices in the Los Angeles area. The subjects were randomly assigned to either the active group or a placebo group. The trial was carried out on 26 patients, 9 of whom were males. They ranged in age from 31 through 73. One patient nom each category did not show up for the final visit (dropouts). All patients signed an informed consent. The substance was administered as one capsule to be taken 30 minutes before each meal. Each subject was weighed (pounds) before and after completion of the study, height was ascertained at each visit, and the waist was measured in inches as well as the hips. The hips were measured at the widest girth while the waist was measured at the umbilicus.

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RONALD M. LAWRENCE, M.D.

In addition, the blood pressure was measured in a standard fashion at the brachial artery in the left upper extremity. From the weight and height measurements. we ascertained the body mass index (BMI) of each subject. This study was continued for four weeks. Patients were instructed not to change their daily activity pattern (exercise), or their food intake. They were told not to change their diet in any way from the preceding four weeks before they began taking the substance. Summary of Results: The study was conducted with 26 patients. Nineteen patients were on the active compound and 7 were on placebo. One patient from each category did not show up for the final visit. Almost every patient taking the active ingredient lost significant weight. There was almost no weight loss observed in patients on placebo. Out of 18 patients, 15 patients (83.33%) lost weight. Eleven patients (61.11%) lost about six pounds. The highest loss was nine pounds. Four patients lost one to two pounds, and two patients maintained their starting weight. One patient gained 17 pounds. This patient was found not to comply with the regimen that was requested, and indeed increased caloric consumption over the four weeks. It is significant that patients with a higher BMI lost more weight. Thirteen out of 18 patients (17.22%) reduced their waist by 0.5 inches to 3 inches. Five out of 18 patients (27.77%) felt an increase in energy while on the active substance. Three out of six placebo patients (50%) gained one pound and one placebo patients lost one pound. Adverse Effects The only adverse effects that occurred were in two patients (a husband and wife), one of whom was on active substance and the other (male) on placebo. They complained of acidity and a bloating sensation soon after starting the capsules. Both of them stopped taking the capsules, then started again and claimed they developed the same symptoms. Therefore, they both discontinued taking the capsules altogether.

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RONALD M. LAWRENCE, M.D. Acute Toxicity Study at St John’s National Academy of Health Sciences, India Concurrently, an acute toxicity study on Wistar rats was done, under OECD guidelines, using a very high dose of 5 g per kg body weight. No mortality or toxicity was observed. Test substance: Aqueous extract of Caralluma fimbriata Test animals: Species I strain used: Adult, Wistar rats Number: 24 rats Age: 3 months Sex: Both sexes No mortality was observed following the administration at a very high dose of 5g/kg body weight. Body weight, feed and water intake in all the rats were comparable with that of the control. Conclusion Both the clinical trials done on Gencor’s Caralluma Fimbriata Extract clearly demonstrate its ability to induce weight loss by appetite suppression. The acute toxicity study on 24 rats and controlled, clinical trials done on a total of 88 patients demonstrate, without doubt, the lack of significant toxicity and no adverse effects whatsoever on any vital systemic function. The standardized extract of Caralluma Fimbriata extract of Gencor is a clinically proven, safe and non-toxic dietary supplement that can be used for the management of obesity, by appetite suppression leading to clinically significant weight loss.

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