Study design
After sample selection, a general information questionnaire was completed for each patient. Body weight was measured for all patients with a scale (Seca, Hamburg, Germany), without shoes and in light clothing. Body height was measured with a mounted tape measure and without shoes. BMI was calculated as weight in kilograms divided by height in meters squared.Information on daily energy and macronutrient intake was obtained by a three-day dietary recall that included two regular days and one weekend day. Average three-days dietary data were analyzed using Nutritionist 4 software for all patients at baseline and at the end of sixth weeks of the study (First Databank Inc., Hearst Corp., San Bruno, CA).The patients were stratified for sex, weight and age before the intervention, and then were randomly assigned (balanced-block method) into three groups, each group consisted of 20 patients, as the aqueous extract group (AG, Patients were recruited by simple random sampling. Enrolled patients were assigned to three groups based on a balanced block randomization list (using Epi Info™ software). Allocation was also based on sequentially numbered opaque pockets (A: treatment group, and B: treatment group, and C: control group), and prescribed medications were packaged in the same containers labeled by A, B, and C, respectively. The patients and researcher were blinded about the content.Subjects’ compliance with the study protocol was assessed once a week by telephone interviews and every two weeks by counting the number of capsules returned.