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.
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.
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);
Parallel
Xuanhuang Runtong Tablet
DrugA synthetic tablet is mainly composed of Radix Rehmanniae, Radix Scrophulariae, Radix Angelicae Sinensis, Semen Persicae, Herba Cistanches, Fructus Cannabis, Semen Cassiae, Fructus Aurantii Immaturus and Aloe.
Xuanhuang Runtong Tablet Simulator
DrugXuanhuang Runtong Tablet Simulator
Complete Spontaneous Bowel Movement (CSBM) response rate after 4 weeks of treatment.
CSBM: The number of spontaneous bowel movements with a complete sense of evacuation without taking rescue laxatives or with the assistance of manipulation. (Taking rescue medications within 24 hours before defecation is not counted as CSBM). Weekly response: If a patient has at least 3 CSBMs in a week and an increase of at least 1 CSBM compared to the baseline, it is considered a weekly response. CSBM response: The patient meets the CSBM weekly response for at least 50% of the weeks during drug treatment (e.g., 3 out of 4 weeks). Overall CSBM response rate = Number of CSBM responders / Total number of observed patients × 100%.
Complete Spontaneous Bowel Movement (CSBM) response rate after 2 weeks of treatment.
Overall CSBM response rate = Number of CSBM responders / Total number of observed patients × 100%.
The change in the number of bowel movements (BM) at the last week compared to baseline
The patient recorded the number of BMs every day using a diary card.
The change in the number of spontaneous bowel movements (SBM) at the last week compared to baseline .
The patient recorded the number of SBMs every day using a diary card.
The change in the fecal characteristics score (using the Bristol Stool Form Scale) at the last week compared to baseline.
Bristol Stool Form Scale： Type 1 Separate hard lumps, like nuts. Type 2 Sausage-shaped but lumpy. Type 3 Like a sausage or snake but with cracks on its surface. Type 4 Like a sausage or snake, smooth and soft. Type 5 Soft blobs with clear-cut edges. Type 6 Fluffy pieces with ragged edges, a mushy stool.Type 7 Watery, no solid pieces. The 1-7 types correspond to scores of 1-7 respectively.
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