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A study on the efficacy of traditional chinese patent medicines for constipation

Clinical study on the efficacy, safety, and cost-effectiveness of Qihuangtongmi Soft Capsules for constipation treatment

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN15490908
Enrollment
260
Registered
2025-12-31
Start date
2025-12-17
Completion date
Unknown
Last updated
2026-01-12

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

Conditions

Constipation Digestive System

Interventions

Experimental Group: Qi Huang Tong Mi Soft Capsules, taken orally 30 minutes after meals, 3 capsules per dose, twice daily
Control Group: Ma Ren Run Chang Soft Capsules, taken orally, 8 capsules per dose, twice daily
A random allocation sequence will be generated using R statistical software with a 1:1 allocation ratio. The sequence will be implemented using sequentially numbered, sealed envelopes. A third party w

Sponsors

Rongchang Pharmaceutical (Zibo) Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Meets Western medical diagnostic criteria for constipation 2.Meets Traditional Chinese Medicine diagnostic criteria for heat-type constipation 3. No constipation medication taken within 2 weeks prior to enrollment; fewer than 3 spontaneous bowel movements per week prior to enrollment 4.Aged between 18 and 70 years, inclusive, any gender 5.Voluntarily participate and sign the informed consent form after understanding the full trial process

Exclusion criteria

Exclusion criteria: 1. Patients with severe primary diseases or malignancies affecting the heart, lungs, kidneys, brain, hematopoietic system, endocrine system, etc. 2.Patients with known allergies to any drug components or those with an allergic constitution (e.g., allergic to two or more drugs or foods) 3.Constipation caused by intestinal stricture due to organic intestinal lesions (e.g., obstructive diseases, gastrointestinal tumors, inflammatory bowel disease, intestinal tuberculosis) or defecation disorders caused by severe organic anal lesions, as diagnosed by the investigator 4.Patients with drug-related constipation: those who have regularly used medications explicitly indicated to cause constipation in the prescribing information (e.g., antispasmodics, antidiarrheals, nonsteroidal anti-inflammatory drugs) within 4 weeks prior to screening, or who cannot discontinue such medications during the study period 5. Women patients during pregnancy and lactation, male subjects and fertile women subjects who are unwilling or unable to adopt effective contraceptive measures during the trial 6. Participants who have enrolled in other drug clinical trials within 3 months prior to screening 7. Other circumstances deemed inappropriate for participation in this trial by the investigator

Countries

China

Contacts

Public ContactJinkai Xu
xujinkai@cnrc.cn+86 18810689823

Outcome results

None listed

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