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
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.
Downloads
References
REFERENCES
Chis IC, Ungureanu MI, Marton A, Simedrea R, Muresan A,
Postescu ID, et al. Antioxidant effects of a grape seed extract in a rat
model of diabetes mellitus. Diab Vasc Dis Res 2009;6:200-4.
Farvid MS, Jalali M, Siassi F, Hosseini M. Comparison of the effects
of vitamins and/or mineral supplementation on glomerular and tubular
dysfunction in Type 2 diabetes. Diabetes Care 2005;28:2458-64.
Giardino I, Edelstein D, Brownlee M. BCL-2 expression or antioxidants
prevent hyperglycemia-induced formation of intracellular advanced
glycation end products in bovine endothelial cells. J Clin Invest
;97(6):1422-8.
Rajasekaran S, Sivagnanam K, Subramanian S. Antioxidant effect
of Aloe vera gel extract in streptozotocin-induced diabetes in rats.
Pharmacol Rep 2005;57:90-6.
Shirwaikar A, Rajendran K, Punitha IS. Antidiabetic activity of alcoholic
stem extract of Coscinium fenestratum in streptozotocin-nicotinamide
induced Type 2 diabetic rats. J Ethnopharmacol 2005;97:369-74.
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
% 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
Creat (mg/dl) 0.87±0.05 0.83±0.09 0.54-1.19 0.62-1.03 0.87±0.16 0.82±0.12 0.37-1.38 0.55-1.09
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
Hb (g/dl) 12.25±0.59 12.6±0.3 10.7-13.7 12.1-13.2 12.5±0.15 12.6±0.41 11.01-14 11.9-13.3
HCT (%) 36.9±1.36 38.5±0.86 33.9-40.4 36.7-40.2 38.13±1.66 38.23±1.11 34.44-42 36.3-40.24
PLC (10
/μl) 248.8±8.9 250.6±18.7 209.8-288.6 217.5-283.9 259.5±14.72 252.2±17 212.65-306.3 213.7-290.7
TWBC (10
/μl) 8.25±0.54 6.9±0.58 6.1-10.4 5.9-7.9 7.9±1.02 7.5±0.51 5.9-9.9 6.6-8.36
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
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
p>0.05 between the pre-treatment values of the control and drug groups indicating that both groups are similar to each other. Statistical analysis carried out by Mann–
Whitney test (non-parametric unpaired t-test),
#
p>0.05 between the post-treatment values of the control and drug groups indicating that there is no difference between
the drug and the placebo on the measured parameters. Statistical analysis carried out by Mann–Whitney test (non-parametric unpaired t-test), ESR: Erythrocyte
sedimentation rate, TWBC: Total white blood cell, Hb: Hemoglobin, ALT: Alanine aminotransferase, AST: Aspartate transaminase, TC: Total cholesterol, TG: Triglyceride,
HDL: High density lipoprotein, LDL: Low density lipoprotein, SEM: Standard error of mean, CI: Confidence of interval
‡
Sachdewa A, Khemani LD. Effect of Hibiscus rosa sinensis Linn. ethanol
flower extract on blood glucose and lipid profile in streptozotocin
induced diabetes in rats. J Ethnopharmacol 2003;89:61-6.
Eidi A, Eidi M, Esmaeili E. Antidiabetic effect of garlic (Allium
sativum L.) in normal and streptozotocin-induced diabetic rats.
Phytomedicine 2006;13(9-10):624-9.
Agrawal N, Singh SK, Singh N, Kalra S, Srivastava G. Oxidative stress
and diabetes. Internet J Geriatr Gerontol 2010;6(1):31.
Pari L, Latha M. Effect of Cassia auriculata flowers on blood sugar
levels, serum and tissue lipids in streptozotocin diabetic rats. Singapore
Med J 2002;43:617-21.
Venkateswaran S, Pari L. Effect of Coccinia indica leaves on antioxidant
status in streptozotocin-induced diabetic rats. J Ethnopharmacol
;84(2-3):163-8.
Kaleem M, Asif M, Ahmed QU, Bano B. Antidiabetic and antioxidant
activity of Annona squamosa extract in streptozotocin-induced diabetic
rats. Singapore Med J 2006;47:670-5.
Chopra RN, Nayar SL, Chopra IC: Glossary of Indian Medicinal Plants.
New Delhi: CSIR; 1956. p. 66-7.
Al-Awadi FM, Gumaa KA. Studies on the activity of individual plants
of an antidiabetic plant mixture. Acta Diabetol Lat 1987;24:37-41.
Ivorra MD, Payá M, Villar A. A review of natural products and plants as
potential antidiabetic drugs. J Ethnopharmacol 1989;27:243-75.
Alarcon-Aguilara FJ, Roman-Ramos R, Perez-Gutierrez S, AguilarContreras
A,
Contreras-Weber
CC,
Flores-Saenz JL.
Study of
the antihyperglycemic
effect
of
plants used
as antidiabetics. J
Ethnopharmacol
;61:101-10.
Satyam SM, Bairy LK, Pirasanthan R. Influence of grape seed extract
and zinc containing multivitamin-mineral nutritional food supplement
on lipid profile in normal and diet-induced hypercholesterolemic rats.
J Clin Diagn Res 2014;8:HC12-5.
Nahas R, Moher M. Complementary and alternative medicine for the
treatment of Type 2 diabetes. Can Fam Physician 2009;55:591-6.
Published
How to Cite
Issue
Section
The publication is licensed under CC By and is open access. Copyright is with author and allowed to retain publishing rights without restrictions.