This study evaluates efficacy of'" Malva sylvestris" in patients with functional constipation from Iran.
Inclusion criteria:Men and women aged 18–65 years with a history of chronic constipation are eligible for the study. Functional constipation was defined according to the criteria of the Rome III as having at least two or more of the following, during 25% of defecation times: 1, straining; 2, lumpy or hard stools; 3, sensation of incomplete evacuation; 4, manual manoeuvres to facilitate defecation; and 5, fewer than three defecations per week. These criteria should have been fulfilled for the 3 previous months with symptom onset at least 6 months prior to diagnosis.
Exclusion criteria includes patients with any of the following conditions: Patients with alarming symptoms (fever, recent weight loss , and anaemia), drug-induced constipation, those with coexisting secondary causes of chronic constipation, including endocrine, metabolic, or neurological disorders, patients with a history of gastrointestinal surgery(exception of appandectomy and cholecystectomy),those with a diagnosis of constipation dominant IBS.
This study is Double-blind, randomized, placebo-controlled clinical trial. 110 patients are assigned to two treatment groups , malva sylvestris or placebo groups.The malva sylvestris or placebo is given as syrup with the same shape and colour, twice daily after breakfast and after lunch for 4 weeks.
The primary outcome measures are , defaecation rate, stool consistency according to the Bristol Stool Form scale, difficulty on defaecation, sensation of incomplete evacuation, or a need for digital manipulation to facilitate evacuation, are evaluated at baseline, 2 and 4 weeks later.