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A Practical RCT of TCM in the Treatment of LCOVID and Analysis of Syndrome Types and Medication Characteristics.

NCT06095258 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 162

Last updated 2023-10-26

No results posted yet for this study

Summary

This is a multi-center, outcome assessor-blinded, practical randomized controlled trial, aiming to compare the actual clinical effectiveness of individualized traditional Chinese medicine and conventional Western medicine in the treatment of long COVID.

Totally 162 patients with long COVID recruited into the study will be randomly assigned to the traditional Chinese medicine treatment group or the Western medicine control group. Patients in the treatment group will receive individualized TCM syndrome differentiation treatment, and patients in the control group will receive conventional Western medicine symptomatic treatment from general Western medicine practitioners for 4 weeks. All patients were followed up once a week (±2 days) during treatment period and followed up by 4 weeks (±2 days) after the treatment. Outcome measurements will be conducted at baseline, the end of treatment (week 4 ±2 days) and the follow-up visit (week 8 ±2 days).

Conditions

Interventions

DRUG

Traditional Chinese medicine treatment

About four to six Chinese medicine practitioners with five to twenty years of clinical work experience will be responsible for patient diagnosis and prescription treatment, and use a uniformly designed data collection form to record the patient's medical history, clinical symptoms and signs, tongue and pulse conditions, and other information. Patients in the treatment group will receive individualized Chinese medicine treatment prescriptions. Patients in the control group received conventional Western medicine treatment, and about 3 to four Western medicine practitioners with five to twenty years of work experience will be responsible for the conventional medicine prescription. The treatment of the two groups will last for four weeks, and the patients will be followed up for four weeks after the treatment. A patient diary will be provided to all participants for recording the drug compliance and any adverse event during the treatment period.

DRUG

Western medicine treatment

Western medicine doctors will mainly use symptomatic drugs to treat long COVID. For example, cough medicine (such as codeine), bronchodilators (such as ventolin), expectorants (such as fluimucil) and so on are used to treat cough, shortness of breath, or other respiratory symptoms. Non-steroidal anti-inflammatory painkillers (such as panadol) are often used for treating headaches, and sedative-hypnotic drugs (such as stilnox) are often used to treat insomnia.

Sponsors & Collaborators

  • Chinese University of Hong Kong

    lead OTHER

Principal Investigators

  • Hongwei Zhang, PhD · School of Chinese Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-01
Primary Completion
2025-11-30
Completion
2026-02-28

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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 NCT06095258 on ClinicalTrials.gov