Effects of a standardized Ayurvedic formulation on diabetes control in newly diagnosed Type-2 diabetics; a randomized active controlled clinical study.
OBJECTIVE
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.


METHODS
Randomized, active control study.


METHODS
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).


METHODS
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).


CONCLUSIONS
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).
Department of Pharmacology and Therapeutics, King George's Medical University, Lucknow, U.P., India.
Harshika
H
Awasthi
Department of Pharmacology and Therapeutics, King George's Medical University, Lucknow, U.P., India. Electronic address: rajendra.nath79@gmail.com.
Rajendra
R
Nath
Department of Medicine, King George's Medical University, Lucknow, U.P., India.
Kauser
K
Usman
CSIR-Central Institute of Medicinal and Aromatic Plants, Lucknow, U.P., India.
Dayanandan
D
Mani
Department of Pharmacology and Therapeutics, King George's Medical University, Lucknow, U.P., India.
Sanjay
S
Khattri
Department of Pharmacology and Therapeutics, King George's Medical University, Lucknow, U.P., India.
Anuradha
A
Nischal
CSIR-Central Institute of Medicinal and Aromatic Plants, Lucknow, U.P., India.
Manju
M
Singh
Department of Medicine, King George's Medical University, Lucknow, U.P., India.
Kamal Kumar
KK
Sawlani
D000328:Adult; D001786:Blood Glucose / Q000187:drug effects; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy*; D005260:Female; D006801:Humans; D007004:Hypoglycemic Agents / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D008297:Male; D008515:Medicine, Ayurvedic; D008687:Metformin / Q000494:pharmacology / Q000627:therapeutic use; D008875:Middle Aged; D010936:Plant Extracts / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*
D001786:Blood Glucose; D007004:Hypoglycemic Agents; D010936:Plant Extracts; D008687:Metformin
Clinical research; Herbal remedies; Polyherbal formulation; Type-2 diabetes