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

• Status: Not yet recruiting
• Trial end date: 2026-02-28
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chinese University of Hong Kong

Criteria

Inclusion Criteria:

• Chinese subjects with age between 6 and 80 years old;

• For those who have recovered from COVID-19, it has been more than 28 days since the date of diagnosis (the diagnosis is confirmed by rapid antigen test or positive nucleic acid test of deep throat saliva or nose/throat swab);

• The average score of the modified COVID-19 Yorkshire Rehabilitation Scale (C19-YRSm) is above 2 (i.e. above the moderate level).

Exclusion Criteria:

• People who have not been infected with COVID-19;

• People who are still positive for COVID-19;

• Known history of some certain serious medical disease, which is in an unstable state or even affects basic survival, such as cardiovascular disease, liver or renal dysfunction, diabetes, cancer, cerebrovascular disease, blood disorders;

• Known impaired hematological characteristics or impaired liver/kidney function;

• People with mild cognitive impairment, that is, those whose age/education matching percentile in the score of the Hong Kong version of Montreal Cognitive Assessment (HK-MoCA) is lower than 16; or those who cannot truthfully fill out the questionnaire due to mental and psychological factors;

• Have used any drugs or other treatment methods for the treatment of COVID-19 in the past week, such as acupuncture, massage, scraping, cupping, etc.;

• Known history of allergy to any traditional Chinese medicine.