China Aoxing Pharmaceutical (China Aoxing) has completed Phase II clinical study for oral TJSL capsules, an investigational drug to treat primary dysmenorrhea (PD) , or menstrual pain, in adult women. Top-line results from this study are expected to be announced in the coming weeks.
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.
The Phase II clinical study was a 12-week, multi-center, randomised, double-blind and placebo-controlled study to evaluate the safety and efficacy of TJSL capsules among 240 patients with primary dysmenorrheal.
In the study the subjects were between 18 and 35 years old enrolled at four 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.
Reportedly, the primary endpoints 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. The size of the trials was powered to achieve statistical significance between the treatment arm versus control arm.
Zhenjiang Yue, chairman and the CEO of China Aoxing, said: “We are very pleased with the results to date and the progress made in TJSL program since we acquired the product last year. We look forward to announcing the results of this trial and initiating Phase III clinical study in the coming weeks. We believe that TJSL has the potential to become a major player in the treatment of menstrual pain and enables us to serve yet another greatly underserved market segment in pain management.”