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Effects of a standardized Ayurvedic formulation on diabetes control in newly diagnosed Type-2 diabetics; a randomized active controlled clinical study.
Complement Ther Med. 2015 Aug; 23(4):555-61.CT

Abstract

OBJECTIVES

The purpose of this study was to investigate the efficacy of a standardized polyherbal formulation consists of aqueous extracts from six herbs, in patients with Type-2 diabetes mellitus.

DESIGN

Randomized, active control study.

INTERVENTIONS

93 patients, newly diagnosed with Type-2 diabetes mellitus were randomly allocated to group 1 (received polyherbal capsules 500 mg/day, up titrated weekly to a maximum of 3 g/day) and group 2 (received Metformin 500 mg/day, up titrated weekly to a maximum of 2 g/day).

MAIN OUTCOME MEASURES

The primary endpoint was effect on the change from baseline in blood glucose (Fasting blood Glucose and Postprandial blood glucose), and glycosylated hemoglobin (HbA1c). The secondary outcome includes the effect on lipid levels, liver enzymes and renal function test.

RESULTS

After 24 weeks, mean laboratory measured fasting and post prandial blood glucose showed a decrease of 25.52% and 24.22% in polyherbal formulation (PHF) treated group, compared to 31.46% and 24% decrease in Metformin treated group (estimated treatment difference -10.8; 95% CI -22.63 to 1.03 and -0.36; -12.1 to 11.38, respectively). Reduction in HbA1c was also similar for PHF and Metformin (estimated treatment difference 0.01; 95% CI -0.51 to 0.53). However, the decrease in the mean total cholesterol level was more pronounced in PHF treated group (estimated mean difference 61.3; 95% CI 55.32 to 67.28) than Metformin treated group (estimated mean difference 41.12; 95% CI 34.92 to 47.32). Also, there was statistical significance between the treatment groups in total cholesterol level at the end of six months treatment (estimated treatment difference 20.18; 95% CI 12.34 to 28.02).

CONCLUSION

The study demonstrated that daily intake of this PHF decreased the glycemic level and improved lipid homeostasis, while maintaining the other serum biochemical levels to the normal, and therefore it may be useful for the patients with Type-2 diabetes. This trial is registered in the Clinical Trials Registry - India (CTRI) (CTRI/2014/03/004490).

Authors+Show Affiliations

Department of Pharmacology and Therapeutics, King George's Medical University, Lucknow, U.P., India.Department of Pharmacology and Therapeutics, King George's Medical University, Lucknow, U.P., India. Electronic address: rajendra.nath79@gmail.com.Department of Medicine, King George's Medical University, Lucknow, U.P., India.CSIR-Central Institute of Medicinal and Aromatic Plants, Lucknow, U.P., India.Department of Pharmacology and Therapeutics, King George's Medical University, Lucknow, U.P., India.Department of Pharmacology and Therapeutics, King George's Medical University, Lucknow, U.P., India.CSIR-Central Institute of Medicinal and Aromatic Plants, Lucknow, U.P., India.Department of Medicine, King George's Medical University, Lucknow, U.P., India.

Pub Type(s)

Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

26275648

Citation

Awasthi, Harshika, et al. "Effects of a Standardized Ayurvedic Formulation On Diabetes Control in Newly Diagnosed Type-2 Diabetics; a Randomized Active Controlled Clinical Study." Complementary Therapies in Medicine, vol. 23, no. 4, 2015, pp. 555-61.
Awasthi H, Nath R, Usman K, et al. Effects of a standardized Ayurvedic formulation on diabetes control in newly diagnosed Type-2 diabetics; a randomized active controlled clinical study. Complement Ther Med. 2015;23(4):555-61.
Awasthi, H., Nath, R., Usman, K., Mani, D., Khattri, S., Nischal, A., Singh, M., & Sawlani, K. K. (2015). Effects of a standardized Ayurvedic formulation on diabetes control in newly diagnosed Type-2 diabetics; a randomized active controlled clinical study. Complementary Therapies in Medicine, 23(4), 555-61. https://doi.org/10.1016/j.ctim.2015.06.005
Awasthi H, et al. Effects of a Standardized Ayurvedic Formulation On Diabetes Control in Newly Diagnosed Type-2 Diabetics; a Randomized Active Controlled Clinical Study. Complement Ther Med. 2015;23(4):555-61. PubMed PMID: 26275648.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Effects of a standardized Ayurvedic formulation on diabetes control in newly diagnosed Type-2 diabetics; a randomized active controlled clinical study. AU - Awasthi,Harshika, AU - Nath,Rajendra, AU - Usman,Kauser, AU - Mani,Dayanandan, AU - Khattri,Sanjay, AU - Nischal,Anuradha, AU - Singh,Manju, AU - Sawlani,Kamal Kumar, Y1 - 2015/06/09/ PY - 2014/06/16/received PY - 2015/06/04/revised PY - 2015/06/04/accepted PY - 2015/8/16/entrez PY - 2015/8/16/pubmed PY - 2016/3/29/medline KW - Clinical research KW - Herbal remedies KW - Polyherbal formulation KW - Type-2 diabetes SP - 555 EP - 61 JF - Complementary therapies in medicine JO - Complement Ther Med VL - 23 IS - 4 N2 - OBJECTIVES: The purpose of this study was to investigate the efficacy of a standardized polyherbal formulation consists of aqueous extracts from six herbs, in patients with Type-2 diabetes mellitus. DESIGN: Randomized, active control study. INTERVENTIONS: 93 patients, newly diagnosed with Type-2 diabetes mellitus were randomly allocated to group 1 (received polyherbal capsules 500 mg/day, up titrated weekly to a maximum of 3 g/day) and group 2 (received Metformin 500 mg/day, up titrated weekly to a maximum of 2 g/day). MAIN OUTCOME MEASURES: The primary endpoint was effect on the change from baseline in blood glucose (Fasting blood Glucose and Postprandial blood glucose), and glycosylated hemoglobin (HbA1c). The secondary outcome includes the effect on lipid levels, liver enzymes and renal function test. RESULTS: After 24 weeks, mean laboratory measured fasting and post prandial blood glucose showed a decrease of 25.52% and 24.22% in polyherbal formulation (PHF) treated group, compared to 31.46% and 24% decrease in Metformin treated group (estimated treatment difference -10.8; 95% CI -22.63 to 1.03 and -0.36; -12.1 to 11.38, respectively). Reduction in HbA1c was also similar for PHF and Metformin (estimated treatment difference 0.01; 95% CI -0.51 to 0.53). However, the decrease in the mean total cholesterol level was more pronounced in PHF treated group (estimated mean difference 61.3; 95% CI 55.32 to 67.28) than Metformin treated group (estimated mean difference 41.12; 95% CI 34.92 to 47.32). Also, there was statistical significance between the treatment groups in total cholesterol level at the end of six months treatment (estimated treatment difference 20.18; 95% CI 12.34 to 28.02). CONCLUSION: The study demonstrated that daily intake of this PHF decreased the glycemic level and improved lipid homeostasis, while maintaining the other serum biochemical levels to the normal, and therefore it may be useful for the patients with Type-2 diabetes. This trial is registered in the Clinical Trials Registry - India (CTRI) (CTRI/2014/03/004490). SN - 1873-6963 UR - https://www.unboundmedicine.com/medline/citation/26275648/Effects_of_a_standardized_Ayurvedic_formulation_on_diabetes_control_in_newly_diagnosed_Type_2_diabetics L2 - https://linkinghub.elsevier.com/retrieve/pii/S0965-2299(15)00096-5 DB - PRIME DP - Unbound Medicine ER -