Trials / Recruiting
RecruitingNCT05709249
Xian-Lian-Jie-Du Optimization Decoction As an Adjuvant Treatment for Prevention of Recurrence of Colon Cancer
Efficacy of Xian-Lian-Jie-Du Optimization Decoction As an Adjuvant Treatment for Prevention of Recurrence of Stage IIIB/IIIC Colon Cancer：a Study Protocol for a Randomized Controlled Trial
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 730 (estimated)
- Sponsor
- Jiangsu Famous Medical Technology Co., Ltd. · Industry
- Sex
- All
- Age
- 20 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
This study is designed as a multi-center, randomized, double-blind, placebo-controlled trial. Subjects in the intervention group will be treated with XLJDOD compound granule. Subjects in the control group will be treated with placebo (XLJDOD mimetic agent).
Detailed description
Subjects in the intervention group will be treated with XLJDOD compound granule. Treatment will begin within 3 months after standard adjuvant chemotherapy and compliance will be continuously monitored. XLJDOD will be taken twice a day, infused with warm water, 1 hour after lunch and dinner. One course of treatment will take 28 days in 1 month, and 2- to 3-day rest. Treatment will continue for 6 courses. Subjects in the control group will be treated with placebo (XLJDOD mimetic agent). The course of placebo in control group will be in accordance with that of XLJDOD in intervention group.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | XLJDOD compound granule | Treatment will begin within 3 months after standard adjuvant chemotherapy and compliance will be continuously monitored. XLJDOD will be taken twice a day, infused with warm water, 1 hour after lunch and dinner. One course of treatment will take 28 days in 1 month, and 2- to 3-day rest. Treatment will continue for 6 courses. |
| DRUG | placebo (XLJDOD mimetic agent) | The course of placebo in control group will be in accordance with that of XLJDOD in intervention group. |
Timeline
- Start date
- 2022-12-01
- Primary completion
- 2027-04-01
- Completion
- 2028-04-01
- First posted
- 2023-02-02
- Last updated
- 2024-12-30
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05709249. Inclusion in this directory is not an endorsement.