Clinical study evaluating the efficacy, safety, and cost-effectiveness of Shu Mi Capsules for constipation treatment
| ISRCTN | ISRCTN87349615 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN87349615 |
| Sponsor | Rongchang Pharmaceutical (Zibo) Co., Ltd. |
| Funder | Investigator initiated and funded |
- Submission date
- 13/01/2026
- Registration date
- 15/01/2026
- Last edited
- 14/01/2026
- 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.There is a special constipation in clinic, and its pathogenesis is related to emotion. This study mainly discusses the curative effect of Shumi capsule on constipation caused by liver qi stagnation.
Who can participate?
Adult patients aged 18 to 65 years who have been diagnosed with constipation and meet the inclusion criteria.
What does the study involve?
This study is a prospective, randomly allocated study. Participants were assigned to two groups: the treatment group received Shu Mi Capsules, while the control group received either Ma Ren Run Chang Soft Capsules or Qi Huang Tong Mi 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 pitfalls. The study drug may have side effects that the team will closely monitor.
Where is the study run from?
This study was conducted at Gansu Provincial Traditional Chinese Medicine Hospital, China.
When is the study starting and how long is it expected to run for?
January 2026 to December 2026.
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Prof Xudong Tian, xytxd@163.com
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. 418 Guazhou Road, Qilihe District, Lanzhou City, Gansu Province
Lanzhou
730050
China
| Phone | +86 15002591589 |
|---|---|
| xytxd@163.com |
Study information
| Primary study design | Interventional | |
|---|---|---|
| Allocation | Randomized controlled trial | |
| Masking | Open (masking not used) | |
| Control | Active | |
| Assignment | Parallel | |
| Purpose | Treatment | |
| Scientific title | Clinical study evaluating the efficacy, safety, and cost-effectiveness of Shu Mi Capsules for constipation treatment | |
| Study objectives | This study mainly discusses the curative effect of Shumi capsule on constipation caused by liver qi stagnation. | |
| Ethics approval(s) |
Approved 05/11/2025, Ethics Committee of Gansu Provincial Hospital of Traditional Chinese Medicine (No. 418 Guazhou Road, Qilihe District, Lanzhou City, Gansu Province, Lanzhou, 730050, China; +86 0931-2687005; 2650187322@qq.com), ref: 2025-047-01 | |
| Health condition(s) or problem(s) studied | Constipation | |
| Intervention | Experimental Group: Shu Mi Capsules, oral administration, taken 30 minutes after lunch and dinner, 6 capsules per dose, twice daily; treatment for 7 days. Control Group: Qi Huang Tong Mi Soft Capsules, taken orally 30 minutes after meals, 3 capsules per dose, twice daily; treatment for 7 days; 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) | Shu Mi Capsules, Qi Huang Tong Mi Soft Capsules, Ma Ren Run Chang Soft Capsules | |
| Primary outcome measure(s) |
| |
| Key secondary outcome measure(s) |
| |
| Completion date | 31/12/2026 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | All |
| Target sample size at registration | 90 |
| Total final enrolment | 90 |
| Key inclusion criteria | 1. Meets Traditional Chinese Medicine diagnostic criteria for constipation 2. Has had fewer than 3 spontaneous bowel movements per week prior to enrollment 3.Aged between 18 and 65 years, inclusive, any gender 4.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. 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 4. Pregnant or lactating women; male subjects; or female subjects of childbearing potential unwilling or unable to use effective contraception during the trial 5. Participants who have enrolled in other drug clinical trials within 3 months prior to screening 6. Other circumstances deemed inappropriate for participation in this trial by the investigator |
| Date of first enrolment | 12/01/2026 |
| Date of final enrolment | 13/01/2026 |
Locations
Countries of recruitment
- China
Study participating centres
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| IPD sharing plan |
Editorial Notes
14/01/2026: Study’s existence confirmed by the Ethics Committee of Gansu Provincial Hospital of Traditional Chinese Medicine, China.
