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Radioprotective Effect of Chinese Herbal Medicine on Oral Mucositis

NCT05040425 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2021-09-10

No results posted yet for this study

Summary

This protocol describes a randomized, double-arm, parallel-group, open-label controlled study that aims to evaluate the efficacy of Chinese herbal medicine on head and neck cancer patients with oral mucositis toxicities and quality of life during radiotherapy.

Conditions

Interventions

DRUG

Zi-Yin-Liang-Ge-San

Zi-Yin-Liang-Ge-San is composed of five herb ingredients, namely Rx. Scutellariae (Huang Qin), Rx. Glycyrrhizae (Gan Cao), Hb. Dendrobii (Shi Hu), Rx. Ophiopogonis (Mai Men Dong), and Hb. Menthae Haplocalycis (Bo He). It is orally administrated trice daily from the first day to the end of RT in the treatment group, aiming to prevent and manage the OM. ZYLGS is manufactured as a concentrated herbal extract, constituted 4 g per packet, and origin from pharmaceutical companies in Taiwan with good manufacturing practice (GMP).

Sponsors & Collaborators

  • National Research Institute of Chinese Medicine, Ministry of Health and Welfare

    collaborator OTHER_GOV

  • Chang Gung Memorial Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-30
Primary Completion
2022-08-17
Completion
2023-04-01

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05040425 on ClinicalTrials.gov