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A single arm, self-control, multicenter clinical trial on the efficacy and safety of Maren Runchang Pill in the treatment of constipated irritable bowel syndrome (gastrointestinal heat accumulation syndrome)

A single arm, self-control, multicenter clinical trial on the efficacy and safety of Maren Runchang Pill in the treatment of constipated irritable bowel syndrome (gastrointestinal heat accumulation syndrome)

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500095358
Enrollment
Unknown
Registered
2025-01-06
Start date
2023-07-20
Completion date
Unknown
Last updated
2025-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Constipated Irritable Bowel Syndrome (Gastrointestinal Heat Accumulation Syndrome)

Interventions

Experimental group:Maren Runchang Wan, oral, 1 pill each time, twice a day
Treatment for 4 weeks

Sponsors

Dongzhimen Hospital, Beijing University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1) Meets the Western medical diagnostic criteria for Constipated Irritable Bowel Syndrome (IBS-C); 2) Traditional Chinese medicine syndrome differentiation is characterized by heat accumulation in the intestines and stomach; 3) Complete autonomous bowel movements within 2 weeks<3 times per week; 4) Age range from 18 to 65 years old (including boundary values), regardless of gender; 5) Voluntarily accept the research plan, undergo timely follow-up and follow-up, and sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1) Pregnant and lactating women, or women with family planning during the study period; 2) Suffering from diseases that affect the conduct or results of the trial, such as mental illness, gastrointestinal bleeding, intestinal obstruction, severe cardiopulmonary disease, digestive system tumors, or a history of gastrointestinal surgery; 3) Individuals who are allergic to the drugs used in this study; 4) In recent 3 days, I have used Chinese herbal decoction and traditional Chinese patent medicines and simple preparations to promote defecation, such as Maziren pill, Wenpi decoction, Simo decoction, Zengye decoction, Jichuan decoction, Huangqi decoction, Maren pill, Maren soft capsule, Maren Runchang pill, Tongbenning tablet, Zhishi Daozhi pill, Qingchang Tongbian capsule, Simo decoction oral liquid, Magnolia officinalis exhaust mixture, Qirong Runchang oral liquid, Ziyin Runchang oral liquid, Cistanche Tongbian oral liquid, Qirong Runchang oral liquid, Biantong capsule, etc; 5) Within 48 hours, use short-term laxatives such as plantain, polycarbonate calcium and wheat bran, lactulose, bisacozide, phenolphthalein, anthraquinone drugs, and castor oil; 6) Participants in other clinical trials within one month; 7) The researchers believe that it is not suitable for participants.

Design outcomes

Primary

MeasureTime frame
Response rate of complete spontaneous bowel movements (CSBM) within 4 weeks of treatment;

Secondary

MeasureTime frame
Comprehensive therapeutic effect of traditional Chinese medicine syndrome on 4 weekends of treatment;Total score of traditional Chinese medicine syndromes after 4 weeks of treatment;Score of each sub item in the 4-week treatment;VAS score for abdominal pain after 4 weeks of treatment;VAS score for urgency of defecation after 4 weeks of treatment;VAS score for abdominal distension after 4 weeks of treatment;Total score and sub scores of IBS-SSS after 4 weeks of treatment;The proportion of subjects with a total IBS-SSS score greater than 75 after 4 weeks of treatment;Treatment for 4 Weekends, IBS-QOL Score and Scores in All Dimensions;The use of remedial medication for treating constipation;

Countries

China

Contacts

Public ContactFuwen Zhang

Dongzhimen Hospital Beijing University of Chinese Medicine

zfw0205@126.com+86 130 7112 3031

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026