Abstract
Objectives and study design:
A nonrandomized, non-placebo-controlled clinical trial to evaluate the efficacy of Cogent db (an herbal preparation; Cybele Herbal Laboratories [PVT] Ltd. Kochi, Kerala State, India) as an adjuvant in the treatment of patients with type 2 diabetes was carried out during 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, India]) 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 3 months it was found that there was a significant decrease in the levels of fasting and postprandial blood glucose, cholesterol, triglycerides, glycated hemoglobin (Hb A1C) 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.
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