Community Based, Multicentered, Randomized, Double Blinded, Placebo controlled Clinical trial of Trachyspermum Copticum Extract Against Stable Angina

Abstract

Introduction: Trachyspermum copticum (Carom seeds) has been reported to have anti-platelet aggregatory, hypolipidemic and anti-oxidant effects. In the present study ,this was evaluated for its efficacy in the management of stable angina.
Patients and Methods. A prospective double blind, randomized, placebo controlled, multicentered interventional study was conducted with patients of stable angina randomized in two groups (100 in each) in Lahore urban community for a period of 6 weeks. In trial group, patients were treated with oral T.copticum extract for 6 weeks in addition to their conventional medical therapy. In placebo group similar preparation was given to the patients alongwith conventional therapy taking already. Anginal symptoms (chest pain, chest tightness, difficulty in breathing, nausea, light headedness and anxiety) were evaluated after every fortnightly i.e.after 2,4 and 6 weeks regarding their presence.
Results: In this trial 200 patients of stable angina were randomly placed in two groups i.e T.copticum (trial) and placebo. There was found no difference in both groups regarding age and sex. All patients were adults. There was significant improvement in the angina signs/symptoms in the T.copticum group as
compared with placebo group(p<0.0001) after the completion of trial period. Regarding safety profile ,there was no difference found in the routine examination before and after trial in both groups, however lipid profile was improved in the T.copticum group.
Conclusion: T.copticum extract significantly improved patients with stable angina.