A study on the efficacy of traditional chinese patent medicines for constipation
| ISRCTN | ISRCTN15490908 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15490908 |
| Sponsor | Rongchang Pharmaceutical (Zibo) Co., Ltd. |
| Funder | Investigator initiated and funded |
- Submission date
- 23/12/2025
- Registration date
- 31/12/2025
- Last edited
- 29/12/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Digestive System
Plain English summary of protocol
Background and study aims
As a common functional gastrointestinal disease, constipation affects about 20% of the general population worldwide and has a serious negative impact on the quality of life of patients. Qihuangtongmi soft capsule has been used in the treatment of constipation for many years, but the evidence-based medicine (EBM) level is low and the strong evidence is insufficient. The aim of this study was to evaluate the efficacy of qihuangtongmi soft capsule in the treatment of constipation.
Who can participate?
Adults aged 18-70 years with a diagnosis of constipation.
What does the study involve?
Participants were divided into two allocation groups, the treatment group received Qi Huang Tong mi soft capsules, the control group received Maren Runchang soft capsules.
What are the possible benefits and risks of participating?
Participating in the study may improve symptoms of constipation, and the information will help researchers and doctors better treat other patients with similar conditions in the future. However, there are potential risks. The study drug may have side effects that the team will closely monitor.
Where is the study run from?
The trial is conducted at three clinical trial centers. The leading unit is Affiliated Hospital of Shandong University of Traditional Chinese Medicine. The study is sponsored by Pharmaceutical (Zibo) Co., Ltd.
When is the study starting and how long is it expected to run for?
December 2025 to December 2026.
Who is funding the study?
Investigator initiated and funded.
Who is the main contact?
Dr Yang Wang, wangyang@cnrc.cn
Contact information
Public, Scientific
No. 17 Lanyan Avenue, High-Tech Zone, Zibo City, Shandong Province
Zibo
255000
China
| Phone | +86 18810689823 |
|---|---|
| xujinkai@cnrc.cn |
Principal investigator
No. 17 Lanyan Avenue, High-Tech Zone, Zibo City, Shandong Province
zibo
255000
China
| Phone | 15901133922 |
|---|---|
| wangyang@cnrc.cn |
Study information
| Primary study design | Interventional | |
|---|---|---|
| Allocation | Randomized controlled trial | |
| Masking | Open (masking not used) | |
| Control | Active | |
| Assignment | Parallel | |
| Purpose | Treatment | |
| Participant information sheet | 48718_PIS_V1.2_26Nov2025.pdf | |
| Scientific title | Clinical study on the efficacy, safety, and cost-effectiveness of Qihuangtongmi Soft Capsules for constipation treatment | |
| Study objectives | Using MaRen Runchang Soft Capsules as the control medication, this study investigates the effects of Qihuang Tongmi Soft Capsules on changes in the frequency of complete spontaneous bowel movements and stool consistency scores, aiming to evaluate its efficacy in treating constipation. | |
| Ethics approval(s) |
Approved 10/12/2025, Ethics Committee of the Affiliated Hospital of Shandong University of Traditional Chinese Medicine (No. 16369 Jingshi Road, Jinan, Shandong Province, jinan, 250014, China; +86 0531-68616733; sdzyydxfsyyllwyh@163.com), ref: AF/SC-08/03.0 | |
| Health condition(s) or problem(s) studied | Constipation | |
| Intervention | Experimental Group: Qi Huang Tong Mi Soft Capsules, taken orally 30 minutes after meals, 3 capsules per dose, twice daily; treatment for 7 days; Control Group: Ma Ren Run Chang Soft Capsules, taken orally, 8 capsules per dose, twice daily; treatment for 7 days; 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 will assign participants to either group A or group B according to the random numbers, and the allocation will be concealed from the investigators responsible for patient recruitment. The randomization code, including the initial seed and block size, as well as the corresponding treatments for groups A and B, will be documented. | |
| Intervention type | Drug | |
| Phase | Not Applicable | |
| Drug / device / biological / vaccine name(s) | Qi Huang Tong Mi Soft Capsules, Ma Ren RunChang Soft Capsules | |
| Primary outcome measure(s) |
| |
| Key secondary outcome measure(s) |
| |
| Completion date | 16/12/2026 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 70 Years |
| Sex | All |
| Target sample size at registration | 260 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 17/12/2025 |
| Date of final enrolment | 23/12/2025 |
Locations
Countries of recruitment
- China
Study participating centres
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 1.2 | 26/11/2025 | 29/12/2025 | No | Yes |
Additional files
- 48718_PIS_V1.2_26Nov2025.pdf
- Participant information sheet
Editorial Notes
24/12/2025: Study’s existence confirmed by the Ethics Committee of the Affiliated Hospital of Shandong University of Traditional Chinese Medicine, China.
