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Efficacy and Safety of Shouhui Tongbian Capsule in the Treatment of Slow Transit Constipation after Marketing: a Single-Center, Open Clinical Study

Efficacy and Safety of Shouhui Tongbian Capsule in the Treatment of Slow Transit Constipation after Marketing: a Single-Center, Open Clinical Study

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300069809
Enrollment
Unknown
Registered
2023-03-27
Start date
2023-03-27
Completion date
Unknown
Last updated
2023-05-29

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

Conditions

Slow Transit Constipation

Interventions

Shouhui group:2 capsules/time, 3 times/day, take for 14 days.

Sponsors

Beijing Anorectal Hospital (Beijing Erlong Road Hospital)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1) Voluntarily sign the informed consent form; 2) Male or female aged 18-70 (including the critical value); 3) Meet the diagnostic criteria for slow transit constipation; 4) Those who are willing and able to take drugs according to the plan and follow the researcher's guidance; 5) Mentally and intellectually normal and able to express feelings well.

Exclusion criteria

Exclusion criteria: 1) Patients judged by the investigator as having organic constipation; 2) Secondary constipation with a clear cause; 3) Patients who have undergone systemic treatment and taken laxatives in the past 2 weeks; 4) Hepatic insufficiency: aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3 times the upper limit of normal value; 5) Patients with renal insufficiency: serum creatinine > 2 times the upper limit of normal value or receiving renal dialysis treatment; 6) Patients with tumor cachexia; 7) Patients with previous history of liver injury caused by Polygonum multiflorum or preparations containing Polygonum multiflorum; 8) Pregnant or pregnant women, lactating women; 9) Allergic constitution or known allergy to any component of this medicine; 10) The investigator judges that the subject's compliance is poor, and the research cannot be completed according to the requirements of the protocol.

Design outcomes

Primary

MeasureTime frame
Wexner Constipation Rating Scale;

Secondary

MeasureTime frame
PAC-QOL quality of life scale;TCM Symptom Evaluation Scale;

Countries

China

Contacts

Public ContactYuru Zhang

Beijing Anorectal Hospital (Beijing Erlong Road Hospital)

zhyr_11@163.com13611156369

Outcome results

None listed

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