Effects of adjunct therapy of a proprietary herbo-chromium supplement in type 2 diabetes: A randomized clinical trial FNx01

• Published in: International journal of diabetes in developing countries 2010-07, Vol.30 (3), p.153
• Main Authors: Ghosal, Shibnath, Biswas, TuhinK, Polley, Gobinda, Pandit, Srikanta, Debnath, PratipK, Mondal, Somoresh, Biswajit, Auddy, Banerjee, Dipankar, Bhattacharyya, Sauryya, Pal, Debasish
• Format: Article
• Language: English
• Subjects: Aqueous solutions; Ayurvedic medicine; Chromium; Diabetes; Hyperglycemia; Insulin resistance
• ISSN: 0973-3930; 1998-3832
• DOI: 10.4103/0973-3930.66512

Background: Chromium chelates/complexes are widely used as nutritional supplements to redress complications of type 2 diabetic mellitus (T2DM) patients. However, most of these chelates could be susceptible to oxidation into toxic Cr(VI) state. Complexation of Cr (III) with gallo-ellagi tannoids produces a herbochromium supplement (HCrS) that maintains its Cr3+ oxidation state under oxidizing circumstances in vitro. It was tested with conventional oral hypoglycemic drugs [(oral antidiabetic drugs (OAD)] for its beneficial effects in T2DM patients. Objective: A randomized clinical study with three OADs with or without HCrS was carried out in T2DM patients to evaluate the efficacy of the HCrS supplement. Materials and Methods: 150 T2DM patients were randomized into six treatment groups. After 60 days of treatment, fasting blood glucose and post-prandial blood glucose (FBG and PPBG, respectively), HbA 1c , HsCRP, oxidized low density lipoprotein (LDL), and urinary microalbumin levels and other diabetic symptoms were evaluated. Statistical Analysis: Findings were compared using one-way analysis of variance (ANOVA) with post hoc pairwise comparisons of groups using the least significant difference method. Results: Better control of FBG and PPBG levels were observed in patients receiving HCrS (-12.4 to -16.6%) compared to placebo groups (-3.4 to -9.4%). There was a 5.5-7.4% decrease in HsCRP and LDL levels in patients receiving HCrS, which is better than placebo treated groups. Significant decrease in urinary microalbumin level was observed in patients receiving HCrS (-20.0 to -22.5%) compared to placebo groups (-7.8 to -11.6%). Significant decreases in diabetic symptoms were observed in patients receiving HCrS (-47.4 to -59.4%) compared to that observed in placebo groups (-18.0 to 34.0%). Conclusion: The findings indicate that HCrS with OAD improves overall diabetic complications within 2 months and may be useful in long-term therapy.