A randomized placebo controlled trial of Inolter (herbal product) in the treatment of type 2 XXXX .

@entity1 @entity6 @entity1674 @entity1503 @entity412 @entity165
OBJECTIVE: To evaluate the safety and effectiveness of Inolter in achieving glycemic control and changes in lipid profile of newly diagnosed type 2 diabetics. MATERIAL AND METHODS:                 <AbstractText Label="STUDY DESIGN" NlmCategory="METHODS">A randomized, placebo-controlled double blind. Sixty newly diagnosed @entity1 of type-2 @entity6 were randomized. Of these, 30 were put on Inolter monotherapy and 30 @entity1 on placebo. Efficacy of Inolter was determined by observing glycemic control by estimating glycosylated haemoglobin (HbA1c) and @entity1503 ( @entity1503 ), alteration of lipid profile by serum @entity165 , LDL, VLDL, HDL and @entity1674 . STATISTICAL METHODS: Student's unpaired 't' test. RESULTS: @entity1 compliance was satisfactory and no adverse effects were observed. Better hypoglycemic effect was observed with Inolter both respect to @entity1503 (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 @entity165 (21.33 +/- 26.05 mg/dl), serum @entity412 (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. CONCLUSION: Inolter appears to be an useful adjunctive therapy to exercise and diet control in newly diagnosed @entity6 .
