A randomized placebo controlled trial of Inolter (herbal product) in the treatment of type 2 diabetes.
OBJECTIVE
To evaluate the safety and effectiveness of Inolter in achieving glycemic control and changes in lipid profile of newly diagnosed type 2 diabetics.


METHODS



METHODS
A randomized, placebo-controlled double blind. Sixty newly diagnosed patients of type-2 diabetes were randomized. Of these, 30 were put on Inolter monotherapy and 30 patients on placebo. Efficacy of Inolter was determined by observing glycemic control by estimating glycosylated haemoglobin (HbA1c) and fasting blood sugar (FBS), alteration of lipid profile by serum cholesterol, LDL, VLDL, HDL and triglycerides.


METHODS
Student's unpaired 't' test.


RESULTS
Patients compliance was satisfactory and no adverse effects were observed. Better hypoglycemic effect was observed with Inolter both respect to fasting blood sugar (mean 65.4 +/- 63.72 mg/dl) compared to placebo (mean 26.45 +/- 38.3 mg/dl) (p < 0.001). The mean change, with Inolter, in serum cholesterol (21.33 +/- 26.05 mg/dl), serum triglyceride (30.36 +/- 32.62 mg/dl), VLDL (8.85 +/- 3.25 mg/dl), LDL (10.00 +/- 4.48 mg/dl) and HDL (-2.33 +/- 5.66 mg/dl) was also significantly different (p < 0.001) from those given placebo, where it was 15.7 +/- 20.14 mg/dl, 8.70 +/- 13.24, 0.10 +/- 4.10 mg/dl, -0.70 +/- 4.58 mg/dl and 0.65 +/- 0.00 mg/dl, respectively.


CONCLUSIONS
Inolter appears to be an useful adjunctive therapy to exercise and diet control in newly diagnosed type 2 diabetes mellitus.
Agrawal
R P
RP
Department of Medicine, SP Medical College, Bikaner.
Sharma
Aradhana
A
Dua
A S
AS
Chandershekhar
Kochar
D K
DK
Kothari
R P
RP
D002784:Cholesterol / Q000097:blood; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D010349:Patient Compliance; D008517:Phytotherapy; D028321:Plant Preparations / Q000627:therapeutic use*; D016896:Treatment Outcome
D007004:Hypoglycemic Agents; D028321:Plant Preparations; D002784:Cholesterol