RecruitingPhase 3NCT05709249

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


Sponsor

Jiangsu Famous Medical Technology Co., Ltd.

Enrollment

730 participants

Start Date

Dec 1, 2022

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 20 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a traditional Chinese herbal medicine formula called Xian-Lian-Jie-Du Decoction, taken after standard chemotherapy, can help prevent colon cancer from coming back in people who have completed surgery and adjuvant treatment. **You may be eligible if...** - You have had surgery for colon cancer (stage IIIB or IIIC) confirmed by pathology, with all cancer removed and at least 3 months of standard chemotherapy completed - You are between 20 and 80 years old - You are enrolled within 3 months of finishing chemotherapy - You are in generally good health with no signs of cancer returning **You may NOT be eligible if...** - You have had another cancer in the past 5 years (besides certain minor skin or cervical cancers) - You have had radiation, targeted therapy, or immunotherapy as part of your cancer treatment - You have been taking anti-cancer Chinese herbal medicines for more than 3 months after surgery or within 1 month before enrollment - You have serious heart, kidney, liver, or blood disorders - You are allergic to any ingredients in the herbal formula Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGXLJDOD 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.

DRUGplacebo (XLJDOD mimetic agent)

The course of placebo in control group will be in accordance with that of XLJDOD in intervention group.


Locations(1)

Jiangsu Province Hospital of Traditional Chinese Medicine

Nanjing, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05709249


Related Trials