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NCT07123116
Shenbai Granules for Preventing Recurrence of Low-Risk Colorectal Adenomas
NA trial testing Shenbai Granules in Colorectal Adenoma in 450 participants. Not yet recruiting.
30 November 2028
Quick facts
| Lead sponsor | Jiangsu Famous Medical Technology Co., Ltd. |
|---|---|
| Phase | NA |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | prevention |
| Enrollment | 450 |
| Start date | 15 August 2025 |
| Primary completion | 30 November 2028 |
| Estimated completion | 30 November 2028 |
| Sites | 1 location across China |
Drugs / interventions tested
- Shenbai Granules — full drug profile →
- Placebo
Conditions studied
- Colorectal Adenoma — all drugs for Colorectal Adenoma →
- TCM — all drugs for TCM →
- Low Risk — all drugs for Low Risk →
Sponsor
Jiangsu Famous Medical Technology Co., Ltd. — full company profile →
Who can join
Adults 40 to 75, any sex, with Colorectal Adenoma or TCM. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Shenbai Granules for Preventing Recurrence of Low-Risk Colorectal Adenomas（LRCRA）. Study Population: Post-resection patients with low-risk colorectal adenomas and Spleen Deficiency with Dampness-Heat Syndrome per TCM criteria. Sample Size: 450 subjects (1:1 randomization; 225 per arm) accounting for ≤20% dropout. Study Hypothesis (Exploratory) ： This exploratory trial aims to evaluate the potential efficacy and safety of Shenbai Granules, a TCM formula, in reducing LRCRA recurrence. Based on preliminary data suggesting a 32.64% relative risk reduction in LRCRA recurrence at 2 years, we hypothesize that Shenbai Granules may demonstrate clinically meaningful prevention of adenoma recurrence and offer a favorable safety profile in the target TCM syndrome population. No formal statistical hypothesis is tested. Statistical Analysis Analysis Sets: mITT (primary efficacy), PPS, SS (safety). Primary Analysis: Proportion difference (Newcombe method) and χ²/Fisher's exact test (stratified CMH if applicable). Sensitivity analyses: PPS, tipping-point imputation for missing data. Safety: Descriptive summaries of AEs/SAEs (MedDRA-coded), lab abnormalities.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07123116
- Europe PMC full search
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Related trials
Other trials of Shenbai Granules
Trials testing the same drug.
- NCT07129499 — Shenbai Granules for Preventing Malignant Transformation of High-risk Colorectal Adenomas · NA · not yet recruiting
- NCT03616444 — A Randomized Clinical Trial of Shenbai Granules in Reducing Recurrence of Colorectal Adenoma · Phase 2, PHASE3 · completed
Other recruiting trials for Colorectal Adenoma
Currently open trials in the same condition.
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- NCT06979232 — Enhanced White Light Endoscopy Versus Conventional White Light Endoscopy for Colorectal Adenoma Detection: A Randomized · NA · recruiting
- NCT07035691 — New bioMarkers tO straTIfy cOlorectal caNcer Referrals · recruiting
- NCT06715384 — Evaluation of a CAM System for Colorectal Polyp Size Measurement · NA · recruiting
- NCT06612281 — Evaluation of Gixam's Performance in a FIT Negative Population · Phase 2 · recruiting
Other Jiangsu Famous Medical Technology Co., Ltd. trials
Trials by the same sponsor.
- NCT07129499 — Shenbai Granules for Preventing Malignant Transformation of High-risk Colorectal Adenomas · NA · not yet recruiting
- NCT06613373 — An Exploratory Clinical Study of CDK4/6i Dalpiciclib Combined With AI Neoadjuvant Therapy for Stage II-III HR+/HER2- Bre · Phase 4 · not yet recruiting
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- NCT06136026 — Integrated Chinese and Western Medicine Specialized Disease Cohort for Colorectal Cancer · not yet recruiting
- NCT05709249 — Xian-Lian-Jie-Du Optimization Decoction As an Adjuvant Treatment for Prevention of Recurrence of Colon Cancer · Phase 3 · recruiting
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 NCT07123116 (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 Jiangsu Famous Medical Technology Co., Ltd.
- Last refreshed: 14 August 2025
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