Agrawal 1996.
Methods | Crossover design and stratification based on age, fasting blood glucose, and body mass index. Generation of allocation sequence: not stated. Blinding: single blind, person doing measurements and analysis. Sample size estimation: no information. Withdrawal/drop‐out: no. | |
Participants | Ethnic: Hindu; 40 patients (M/F 25/15; mean age 52.5 (41 ‐ 65 ) years; 20 in herb group; 20 in placebo group). Setting: community clinic. Inclusion criteria: non‐insulin‐dependent diabetes mellitus (NIDDM) diagnosed by WHO criteria of 1985. Exclusion criteria: patients took holy basil leaves; had blood urea, diarrhoea or dysentery, cancer, 2‐hour postprandial blood glucose > 350 mg/dl, did not like to eat the herb, and juvenile diabetes. | |
Interventions | Experimental intervention:
Holy basil leaves (dried leaf powder in a sachet containing 2.5 g of fresh leaves), in 200 ml water, drink the mixture,daily, for two months. Control intervention: Placebo (spinach leaf powder in a sachet), in 200 ml water, drink daily, for two months. Before starting the interventions, patients were advised not to take any diabetic treatment at least seven days, then followed a run‐in period of 5‐day to wash out the remaining effect of hypoglycaemic drugs. |
|
Outcomes | FBG, PBG, total cholesterol, body weight, and adverse effect. Only data from the first period of trial (before crossover) were used. |
|
Notes | Data from body weight were not available. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment? | Unclear risk | B ‐ Unclear |