Our Health Remedies | Davenben Enterprises Corp.

COGENT db+: MAKING LIFE BETTER FOR DIABETICS

SCIENTIFIC AND CLINICAL EVALUATION OF THE HERBAL SUPPLEMENT

A number of animal experimentation studies (published and unpublished) and human clinical trials (published and unpublished) have been carried out in various medical institutions in India and other parts of the world (Malaysia, Sudan, etc). Most of the toxicological and teratogenicity studies were conducted at the Department of Toxicology, The Frederick Institute of Plant Protection and Toxicology in the Padappai, Kanchepuram District, Tamil Nadu, India. The list of studies conducted by this Institute is as follows:

Animal Experimentation - Unpublished data (Reports)

Kandasamy R, Ramachandran PV & Murthy PB. Acute oral toxicity study into a herbal preparation in Wistar Rats.
Kandasamy R, Ramachandran PV & Murthy. A 14-day repeated oral toxicity study with a herbal preparation in Wistar Rat. One animal study (clinical aspects) was conducted at the National Institute of Nutrition, Indian Council of Medical Research, Hyderabad, India.
Giridharan NV. Effect of Cogent db+ on mutant obese rats with impaired glucose tolerance (WNIN/GR-Ob). 2000.

Summary of the animal studies

  • The LD50 for Wistar rat of Cogent db+ was considered greater than 6000 mg/kg body weight.
  • The herbal preparation even with the dose of 1000 mg/kg body weight was considered safe in Wistar rats.
  • Cogent db+ was not teratogenic in Wistar rats.
  • Cogent db+ had exhibited hypoglycemic and hypocholesterolemic effect.
  • The general well-being in terms of increased activity was observed in treated animals.

Unpublished human clinical trials are as follows:

  1. Kuttan R. Clinical evaluation in ten patients taking anti-diabetic herbal preparation (Cogent db+) - first preliminarystudy - 1998.
  2. Kamath S, Sharat Kumar W, Singh RG, Usha K. Effect of Cogent db+ (a herbal formulation) in the treatment of Diabetes mellitus. Banaras Hindu University, Medical College, Department’s of Pediatrics, Nephrology and Pathology. 2000.**
  3. Jayakumar RV. Clinical evaluation of herbal preparation in non-insulin dependent Diabetes mellitus - a double blind placebo controlled trial. Department of Medicine, Medical College Trivandrum, Kerala, India.2000.
  4. El-Toum MA. Anti-diabetic activity of Cogent db+ tablets on 30 patients in Khartoum, Sudan. 2000.
  5. Cyebele. A randomized clinical trial on 100 diabetic patients with Cogent db+. 2000.
  6. Cybele. The utilization of Cogent db+ on the treatment of 80 diabetic patients.

The results of all the unpublished studies can be summarized as follows:

In diabetic patients taking the supplement
Blood glucose (fasting & post-prandial) was lowered.

  • Glycated hemoglobin which was elevated was found to be lowered at the end of three months (HbA1c)
  • Consistent decrease in urinary glucose in cases where it was elevated
  • Increased tolerance to glucose
  • The supplement produced a lowered fasting blood glucose which did not alter even after withdrawing the supplement
  • No change in hepatic, kidney or hematological parameters was observed, concluding that the drug did not produce toxicity.
  • Patients who were on insulin therapy also showed response and the subsequent insulin requirement decreased at the end of 4 months.**
    • Published papers

      Three animal studies and one human clinical trial have been published in reputed International journals.

      Animal studies

      1. Joy KL, Kuttan R. Anti-diabetic effect of Cogent db+ -a herbal preparation. Amala Research Bulletin 1998; 18: 109-114.
      2. Pari L, Saravanan L. Anti-diabetic effect of Cogent db+, a herbal supplement in alloxan-induced diabetes mellitus. Comparative Biochemistry and Physiology 2000; Part C 131: 19-25.
      3. Saravanan G, Pari L. Effect of Cogent db+, a herbal supplement on serum and tissue lipid metabolism in experimental hyperglycemic rats. Diabetes, Obesity and Metabolism 2003; 5:
      4. Saravanan G, Pari L, Venkateswaran S. Effect of Cogent db+, a herbal supplement, on plasma insulin and hepatic enzymes of glucose metabolism in experimental diabetes. Diabetes, Obesity and Metabolism 2002; 4:

      Human Clinical Trial

      Shekhar KC, Achike FI, Gurpreet Kaur, Kumar P, Hashim R. A preliminary evaluation of the efficacy and safety of Cogent db+ (An Ayurvedic supplement) in the Glycemic control of patients with Type-2 diabetes. T he Journal of Alternative and Complementary Medicine 2002; Volume 8, Number 4; 445-457.

      1. Joy KL, Kuttan R. Anti-diabetic effect of Cogent db+ -a herbal preparation.

      Summary

      Herbal preparation made available by Cybele Laboratories, Cochin was tested for anti-diabetic activity in rats made hyperglycemic by alloxan injection. Oral administration of an extract of the preparation was found to reduce blood glucose in normal rats, rats made diabetic by alloxan injection, and in rats loaded with glucose. Effect could be seen within 12 hours at concentration of 100 mg/kg body weight.

      Continued administration of the supplement was found to produce further lowering of the blood glucose. There was also a normalization of glycated hemoglobin. The extract was found to improve the body weight and the total WBC. The hepatic function, as seen from the serum glutamate pyruvate transaminase, serum bilirubin and serum lipid peroxidase was found to be normal after the administration of the extract. Similarly, a kidney function test showed a positive improvement as seen from the serum creatinine and blood urea nitrogen.

      Histopathological analysis indicated that inflammation and necrosis produced by alloxan was reversed by simultaneous administration of this herbal preparation. [Figures 1, 2 and 3]. Comparison with Daonil (a Glibenclamide preparation) indicated that the extract produced more satisfactory performance as seen from the reduction in blood glucose when given orally. The extract did not produce any toxicity even at concentrations of 500 mg/kg body weight, in rats tested. 75% alcoholic extract gave most satisfactory effects followed by water extract.



      2. Pari L, Saravanan L. Anti-diabetic effect of Cogent db+, a herbal supplement in alloxan-induced diabetes mellitus. Comparative Biochemistry and Physiology 2000; Part C 131: 19-25.

      Abstract

      Cogent db+, a compound herbal supplement was investigated for its possible anti-diabetic effect in alloxan-induced diabetic rats. Oral administration of 0.15, 0.30 and 0.45 g/kg body weight of the aqueous solution of Cogent db+ for 40 days exhibited a significant reduction in blood glucose, glycosylated hemoglobin and increased plasma insulin, total hemoglobin along with anti-hyperlipidemic effects in diabetic rats. The effective dose was found to be 0.45 g/kg body weight. It also prevents body weight loss in diabetic rats. An oral glucose tolerance test (OGTT) was also performed in experimental diabetic rats in which there was a significant improvement in glucose tolerance in rats treated with Cogent db+. A comparison was made between the action of Cogent db+ and known anti-diabetic drug glibenclamide (600 µg/kg body weight). The anti-diabetic effect of Cogent db+ was more effective than that observed in glibenclamide.

      3. Saravanan G, Pari L. Effect of Cogent db+, a herbal supplement on serum and tissue lipid metabolism in experimental hyperglycemic rats. Diabetes, Obesity and Metabolim 2003; 5.

      Abstract

      Aims: We have previously reported the anti-diabetic effect of Cogent db+. The present study with alloxan-induced hyperglycemic rats is focused on the mechanism of action, specifically on the activity of hepatic lipogenic enzymes, serum and tissue lipids.

      Methods: Male Wistar rats body weight of 180-200 g (six normal and 18 diabetic rats) were used in this study. The rats were divided into four groups after the induction of alloxan diabetes: normal rats; diabetic control; diabetic rats given Cogent db+ (0.45 g/body kg weight); diabetic rats given glibenclamide (600 µg/kg body weight). After 40 days treatment, fasting blood glucose, plasma insulin, activities of hepatic lipogenic enzymes, serum and tissue lipids were determined in normal and experimental animals.

      Results: Oral administration of Cogent db+ for 40 days resulted in significant reduction in blood glucose, serum and tissue (liver and kidney) lipids, whereas the levels of plasma insulin and the activity of hepatic lipogenic enzymes were significantly increased in alloxan diabetic rats. Similar studies using glibenclamide have been conducted to compare the mode of action of these two drugs.

      Conclusions: Thus, our study shows that Cogent db+ exhibits a strong anti- hyperlipidaemic effect which could exert a beneficial action against macrovascular complications (cardiovascular diseases) associated with diabetes mellitus.

      4. Saravanan G, Pari L, Venkateswaran S. Effect of Cogent db+, a herbal supplement, on plasma insulin and hepatic enzymes of glucose metabolism in experimental diabetes. Diabetes, Obesity and Metabolism 2002; 4.

      Abstract

      Aims: The present study was designed to investigate the effect of Cogent db+, a polyherbal drug on blood glucose, plasma insulin and the activities of hepatic glucose metabolic enzymes in alloxan-induced diabetic rats.

      Methods: Male Wistar rats body weight of 180-200 g (six normal and 18 diabetic rats) were used in this study. The rats were divided into four groups after the induction of alloxan diabetes. In the experiment, six rats were used in each group. Group 1, normal rats given 2 ml of saline; Group 2, diabetic control rats given 2 ml of saline; Group 3, diabetic rats given aqueous solution of Cogent db+ (0.45 g/kg body weight); and Group 4, diabetic rats given aqueous solution of glibenclamide (600 µg/kg body weight). The treatment was given for 40 days. After the treatment, fasting blood glucose, plasma insulin, urine sugar and the activities of hepatic glucose metabolic enzymes were determined in normal and experimental animals.

      Results: Treatment with Cogent db+ resulted in a significant reduction in blood glucose and the activities of glucose-6-phosphatase and fructose-1, 6- bisphosphatase in the liver, whereas the level of plasma insulin and hepatic hexokinase activity were significantly increased in alloxan-diabetic rats.

      Conclusions: The present investigation suggests that Cogent db+ controls the blood glucose level by increasing glycolysis and decreasing gluconeo- genesis with a lower demand of pancreatic insulin than in untreated rats. This is possible because it regulates the acitivities of hepatic glucose metabolic enzymes.

      Shekhar KC, Achike FI, Gurpreet Kaur, Kumar P, Hashim R. A preliminary evaluation of the efficacy and safety of Cogent db+ (An Ayurvedic supplement) in the Glycemic control of patients with Type-2 diabetes. The Journal of Alternative and Complementary Medicine 2002; Volume 8, Number 4; 445-457.

      Abstract

      Objectives and Study Design: A non-randomized, non-placebo-controlled trial to evaluate the efficacy of Cogent db+ (an herbal preparation; Cybele Herbal laboratories [PVT] Ltd. Cochi, Kerala State, India) as an adjuvant in the treatment of patients with type 2 diabetes was carried out over a 3-month period.

      Settings/Location: This study was conducted in two major peripheral clinics of Kuala Lumpur in the Klang Valley, Malaysia.

      Subjects: A total of 39 Cogent db+ -treated cases and 40 age-matched controls were recruited for this preliminary study. Nineteen (19) subjects (10 and 9 from control and treatment groups, respectively) dropped out of the study leaving a total of 60 subjects (30 each for control and treatment groups) who completed the study.

      Interventions: All subjects in the treatment group were given Cogent db+ (2 tablets three times daily after each meal) in addition to the regular allopathic drugs (Daonil [Aventis Farma, SA Petaling Jaya, Selangor State, Malaysia] and Diamicron [Sevier, Bangkok, Thailand] with or without Metformin [Upha Corporation, Bangi, Selangor State, Malaysia] that they took in common with the control group.

      Outcome measures: Thirty-two (32) clinical variables were investigated, including liver enzymes, kidney function tests, hematologic parameters, blood glucose, insulin and C-peptide assays.

      Results: At the end of three months, it was found that there was a significant decrease in the levels of fasting and postprandial blood glucose, cholesterol, triglycerides, glycated hemoglobin (HBA1c) and fasting insulin in the treatment group compared to the controls. Cogent db+ did not alter the liver function tests, hematologic parameters or the kidney function tests.

      Conclusions: These results concur with earlier animal studies that indicate that Cogent db+ is safe, reliable, tolerable and efficacious in the control of type 2 diabetes mellitus.