A 45-DAY RANDOMIZED, OPEN-LABEL, COMPARATOR STUDY TO EVALUATE THE SAFETY AND EFFICACY OF ZINCOVIT TABLETS WITH GRAPE SEED EXTRACT (NUTRITIONAL FOOD SUPPLEMENT) IN PATIENTS WITH TYPE 2 DIABETES MELLITUS

  • Yeshwanth Rao
  • Sudha Vidyasagar
  • Laxminarayana Bairy K Department of Pharmacology, Kasturba Medical College, Manipal University, Manipal-576104

Abstract

ABSTRACT
Objective: To evaluate the efficacy of Zincovit (ZVT) tablets with grape seed extract (GSE) in patients with Type 2 diabetes mellitus by testing the
hypothesis of a greater reduction in plasma glucose levels (fasting blood sugar [FBS] and post-prandial blood sugar [PPBS]) from baseline and after
45 days of therapy as compared to standard comparator.
Methods: This was a randomized, open-label, comparative (2-arm), prospective 45 days study. Treatment consisted of 2 arms: Antidiabetic drug
plus non-pharmacological measure alone or ZVT tablets with GSE plus non-pharmacological measures. A total of 30 patients (15 in each arm) were
included in the study.
Results: ZVT tablet did not alter the FBS, PPBS, and HbA1c level in diabetic patients compared to diabetic patients treated with placebo. No changes
were seen in any of the safety parameters when given for 45 days.
Conclusion: ZVT tablets do not possess antidiabetic activity in spite of good safety profile in our study design. This could be due to several limitations
of the study such as inadequate sample size, short duration of the study, and wrong selection of the patients. A long-term, double-blind, placebo
controlled study in a large sample of population measuring glycemic parameters, and cardiovascular outcomes could give a clear picture of the antidiabetic
effect
of ZVT with GSE tablets.
Keywords: Diabetes mellitus, Zincovit tablets, Grape seed extract, Antioxidant, Safety parameters.

Author Biography

Laxminarayana Bairy K, Department of Pharmacology, Kasturba Medical College, Manipal University, Manipal-576104

Professor of Pharmacology

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Post-treatment values
(mean±SEM) (n=15)
‡
Control Drug Control Drug Control Drug Control Drug
ALT (IU/l) 27.7±4 22.6±4 14.41-41.11 15.7-29.5 26.5±3.7 23.9±3.32 16.84-36.16 17.39-29.4
95% CI
AST (IU/l) 24.5±2.72 22.4±1.6 15.5-33.9 18.4-25.5 23.8±2.5 21.8±1.62 16.8-30.9 18.8-24.7
TC (mg/dl) 181±15.12 171.6±14.79 156.9-206.1 143.1-199 195.25±20.8 163.7±10.6 166.9-225.6 144.8-181.6
TG (mg/dl) 126±32.9 129.2±16.2 81.5-172.5 99.5-159.9 138.75±32.2 115.7±15.42 80.2-196.28 87.8-144.6
HDL (mg/dl) 51.25±12 48.9±4.67 32.7-97.7 39.3-56.4 50.71±11.3 50.23±5.09 31.29-69.21 41.29-58.3
LDL (mg/dl) 104±12.2 97.5±13.29 96.2-122.8 73.4-121.6 117.75±20.5 92.7±9.25 85.62-149.9 76.79-108.6
TC/HC 3.84±0.89 3.63±0.29 2.6-5.4 3.1-4.2 4.4±0.78 3.3±0.32 2.4-6.3 2.7-3.9
Urea (mg/dl) 23.25±2.59 25±4.79 11.9-35.5 17.17-33.8 22.5±2.72 23.5±2.8 13.83-31.17 18.16-27.8
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Na (mmol/l) 136.14±1.7 136.92±0.39 132.2-139.78 135.9-138.7 141.25±1.32 37.1±0.92 139-143.43 135.32-138.4
K (mmol/l) 4.12±0.35 4.4±0.14 3.6-4.6 4.16-4.71 4.38±0.24 4.31±0.13 3.9-4.7 4.1-4.53
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PLC (10
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TWBC (10
3
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N (%) 51.9±3.25 51.12±2.2 44.8-59.2 45.3-56.6 49.85±3.84 51.63±2.18 37.64-62.06 46.69-56.57
L (%) 36.13±3.45 35.87±2.7 30.5-41.6 29.8-41.8 39.37±4.3 36.12±2.36 25.65-53.09 30.78-41.5
M (%) 6.4±1.3 87.5±0.3 4.38-8.67 6.75-8.3 6.4±0.4 6.6±0.34 5.1-7.8 6.4-7.3
E (%) 6.13±1.72 4.8±0.86 1.8-10.4 3.3-6.3 6.1±1.72 5.2±0.84 3.03-9.3 3.64-6.87
B (%) 0.4±0.03 0.67±0.09* 0.23-0.56 0.51-0.84 0.5±0.04 0.62±0.12 0.34-0.65 0.39-0.85
3
ESR 31.7±7.98 24.3±3.23 17.35-46.07 16.9-31.1 40.25±7.04 25±4.17 17.85-62.65 15.57-34.43
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Whitney test (non-parametric unpaired t-test),
#
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How to Cite
Rao, Y., S. Vidyasagar, and L. Bairy K. “A 45-DAY RANDOMIZED, OPEN-LABEL, COMPARATOR STUDY TO EVALUATE THE SAFETY AND EFFICACY OF ZINCOVIT TABLETS WITH GRAPE SEED EXTRACT (NUTRITIONAL FOOD SUPPLEMENT) IN PATIENTS WITH TYPE 2 DIABETES MELLITUS”. Asian Journal of Pharmaceutical and Clinical Research, Vol. 9, no. 2, Mar. 2016, pp. 220-2, https://innovareacademics.in/journals/index.php/ajpcr/article/view/10436.
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