NCT05040425|UnknownPhase 2DMC
Loading search results
Sponsor study identifier
interventional
200
0 countries
N/A
Study Start
August 30, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
August 17, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
April 1, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 1, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 30, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
September 3, 2021
Actual (reported)September 10, 2021
Actual (reported)August 17, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
April 1, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Degree of oral mucositis
The degree was graded by the NHI Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0)
During the radiotherapy course, up to 6 weeks
Mucositis pain
100-mm-visual analog scale (VAS, 0-100)
During the radiotherapy course, up to 6 weeks
Health related-QoL (1)
Baseline, 4th week, and 6th week of radiotherapy completion
Health related-QoL (2)
Baseline, 4th week, and 6th week of radiotherapy completion
Body mass index (BMI)
During the radiotherapy course, up to 6 weeks
Traditional Chinese medicine constitution
Baseline, 4th week, and 6th week of radiotherapy completion
Electrical body conductivity
Baseline, 4th week, and 6th week of radiotherapy completion
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).
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
First Submitted
September 3, 2021
First Posted
September 10, 2021
Study Start
August 30, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Contact the study team to confirm eligibility.
Primary Completion
August 17, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
April 1, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
September 10, 2021
Record last verified: 2021-08
The datasets during and/or analyzed during the current study available from the corresponding author on reasonable request.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: