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A phase II clinical randomized controlled study of a traditional Chinese medicine compound for the treatment of acute radiation-induced esophagitis

A phase II clinical randomized controlled study of a traditional Chinese medicine compound for the treatment of acute radiation-induced esophagitis

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400092981
Enrollment
Unknown
Registered
2024-11-26
Start date
2023-12-26
Completion date
Unknown
Last updated
2024-12-02

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

Conditions

acute radiation-induced esophagitis

Interventions

Test group:Esophagitis prescription was given 2ml tid orally.Generally, the drug was given 5 days a week and rested for 2 days for 4 consecutive weeks, followed up for 1 month.
Control group:The control group was given Lining glue 10pm 3G tid+ sucralfate 10ml tid+ fluconazole 200mg QD orally.usually given 5 days a week for 2 days rest for 4 weeks, and were followed up for 1

Sponsors

The First Affiliated Hospital of Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1) 18-75 years old; 2) Lung / esophageal cancer patients with radiotherapy indications; 3) ECOG score 0-1; 4) ability to drink water or take oral Chinese medicine granules; 5) expect to survive more than 48 weeks; 6) voluntarily and sign informed consent

Exclusion criteria

Exclusion criteria: 1) esophageal stenting has been performed. 2) when the patients were enrolled in the study, they could not eat at all. Unable to swallow or take oral test drugs. 3) pregnant and lactating women. 4) known or suspected to be allergic to tested drugs or to any drug given in connection with this trial. 5) Drug abuse and medical, psychological or social conditions may interfere with patients' participation in the study or affect the evaluation of the results of the study. 6) patients who the researchers believe are not suitable for the study.

Design outcomes

Primary

MeasureTime frame
Pain disappearance time;

Secondary

MeasureTime frame
Safety index;Curative effect index;Esophagography;Nutritional status;Psychological evaluation;Taste evaluation;

Countries

China

Contacts

Public ContactBaoguo Sun

The First Affiliated Hospital of Sun Yat-sen University

Sunbaoguo666@126.com+86 133 1613 4352

Outcome results

None listed

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