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NCT07534995
A Prospective, Multicenter, Randomized, Parallel-controlled, Superiority Trial
Phase 3 trial testing the Shouhui Tongbian Capsule in OIC in 270 participants. Not yet recruiting.
30 December 2027
Quick facts
| Lead sponsor | First Teaching Hospital of Tianjin University of Traditional Chinese Medicine |
|---|---|
| Phase | Phase 3 |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 270 |
| Start date | 30 May 2026 |
| Primary completion | 30 December 2027 |
| Estimated completion | 30 December 2027 |
Drugs / interventions tested
- the Shouhui Tongbian Capsule
- Lactulose (LACTULOSE) — full drug profile →
Conditions studied
- OIC — all drugs for OIC →
Sponsor
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Who can join
Adults 18 to 85, any sex, with OIC. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study intends to design and conduct a prospective, multicenter, randomized, parallel-controlled, superiority trial to evaluate the symptom-relieving effects of Shouhui Tongbian Capsule on opioid-induced constipation (OIC) in cancer patients, including defecation frequency, stool consistency, symptom scores, quality of life and other indicators, and to systematically observe its safety in clinical application. Through analysis of intestinal flora, the mechanism of Shouhui Tongbian Capsule in regulating intestinal function will be revealed. By screening the optimal population for Shouhui Tongbian Capsule in the treatment of OIC, evidence will be provided for optimizing individualized medication. The primary efficacy endpoint is the proportion of responders at week 2 of treatment, defined as an increase of ≥1 in the average weekly number of spontaneous bowel movements (SBMs) compared with baseline and at least one SBM during that week. Secondary endpoints include weekly number of SBMs, weekly number of complete spontaneous bowel movements (CSBMs), Bristol Stool Form Scale score, straining score, Patient Assessment of Constipation-Symptoms (PAC-SYM) score, and Patient Assessment of Constipation-Quality of Life (PAC-QOL) score. Safety endpoints mainly include the incidence of adverse events and changes in vital signs, electrocardiography, routine blood and urine tests, as well as liver and renal function before and after treatment. Meanwhile, based on clinical study data, the characteristics of the optimal population for Shouhui Tongbian Capsule in treating OIC will be identified to further enrich the application scenarios of this capsule for OIC.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07534995
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Related trials
Other First Teaching Hospital of Tianjin University of Traditional Chinese Medicine trials
Trials by the same sponsor.
- NCT07262710 — Association of Angiotensin-Converting Enzyme Inhibitors and Angiotensin Receptor Blockers With Post-Stroke Pneumonia: A · not yet recruiting
- NCT06537440 — Electroacupuncture for Opioid-Induced Constipation in Cancer Patients: A Randomized Clinical Trial · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07534995 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
- Last refreshed: 16 April 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07534995.
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