About this trial
This trial is a randomized, double-blind, placebo-controlled parallel-group, multicenter Phase III clinical trial. It is to evaluate the efficacy and safety of Xuanhuang Runtong Tablets in subjects with constipation (Yin-deficiency type) after 4 weeks of treatment.
Eligibility criteria
Qualifiers
Meeting the diagnostic criteria of traditional Chinese medicine (TCM) constipation;
Meeting the TCM syndrome differentiation criteria of constipation with yin deficiency syndrome;
Both males and females are eligible, aged between 18 and 70 years old (including 18 and 70);
Willing to participate in the trial and sign the informed consent form.
Disqualifiers
Subjects with constipation or severe anal diseases causing defecation disorders diagnosed by researchers due to rectal, colonic organic diseases (such as tumors, inflammatory bowel diseases, intestinal adhesions, colon tuberculosis, etc.);
Subjects with constipation caused by central nervous system diseases (such as multiple sclerosis, Parkinson's disease, spinal cord injury, etc.) or muscle diseases (such as amyloidosis, dermatomyositis, etc.) known or identified as being caused by drugs;
Subjects with colonoscopy results showing intestinal polyps > 0.5 cm or quantity > 3 (subjects with removed intestinal polyps are not excluded, but those with tubular adenoma accompanied by high-grade intraepithelial neoplasia or those who need to re-examine colonoscopy in the near future are excluded);
Subjects who have taken drugs for treating constipation within 1 week before screening or within 5 half-lives (calculated according to the longer time);
Trial design
Treatments tested in this trial
- Xuanhuang Runtong Tablet
- Xuanhuang Runtong Tablet Simulator