Status:
NOT_YET_RECRUITING
A Practical RCT of TCM in the Treatment of LCOVID and Analysis of Syndrome Types and Medication Characteristics.
Lead Sponsor:
Chinese University of Hong Kong
Conditions:
Long COVID
Eligibility:
All Genders
6-80 years
Phase:
PHASE2
Brief 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 conventi...
Detailed Description
The novel coronavirus has caused a global pandemic since the end of 2019. As of November 27, 2022, 637 million people have been diagnosed worldwide and more than 6 million people have died. Studies ha...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2026
Estimated Enrollment :
162 Patients enrolled
Trial Details
Trial ID
NCT06095258
Start Date
December 1 2023
End Date
February 28 2026
Last Update
October 26 2023
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