China Aoxing Completes Menstrual Pain Drug Clinical Study
- Posted on 07 January 2010
China Aoxing Pharmaceutical Company, a pharmaceutical company specializing in the research, development, manufacturing and distribution of narcotic and pain-management products, has announced that it completed a Phase II clinical study for oral TJSL capsules, a novel investigational drug to treat Primary Dysmenorrhea (PD) , or menstrual pain, in adult women.
The Phase II clinical study was a 12-week, multi-center, randomized, double-blind and placebo-controlled study to evaluate the safety and efficacy of TJSL capsules among 240 patients with primary dysmenorrheal. Subjects were between 18 and 35 years old enrolled at four leading university teaching hospitals in metropolitan areas of China. Subjects received TJSL capsules or placebos, three times a day for ten days, starting at one week prior to each menstrual cycle or period.
The primary endpoints that were used to evaluate the efficacy were the sum of pain score differences, measured by Visual Analogue Scale (VAS), as well as symptom improvement during menstruation over three menstrual cycles.
TJSL is a capsule form of selected herbal medicines. Its mechanism of action deserves further investigation, but appears to be its capability of reversing the effects of endometrial prostaglandin, reducing the frequency and strength of uterine contraction as well as providing pain relief, based on in vivo study.
