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

NCT06095258 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: Parametric LCOVID
• Study Type: interventional
• Target: 162
• Locations: 0 countries
• Sites: N/A

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 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

Long COVID

Keywords

Traditional Chinese medicine

Outcome Measures

Primary Outcomes (2)

• 5-level EQ-5D version (EQ-5D-5L)

  The 5-level EQ-5D version (EQ-5D-5L) was developed by the European Society for Quality of Life (EuroQol) and has been validated \[38\]. The EQ-5D-5L assesses a patient's quality of life by assessing five dimensions: mobility, self-care, daily activities, pain or discomfort, and anxiety or depression. Each aspect is assessed by 5 levels, namely none, mild, moderate, heavy, and very severe. In addition, patients self-rated their overall health status using a visual analog scale (EQVAS).

  4 weeks

• 5-level EQ-5D version (EQ-5D-5L)

  The 5-level EQ-5D version (EQ-5D-5L) was developed by the European Society for Quality of Life (EuroQol) and has been validated \[38\]. The EQ-5D-5L assesses a patient's quality of life by assessing five dimensions: mobility, self-care, daily activities, pain or discomfort, and anxiety or depression. Each aspect is assessed by 5 levels, namely none, mild, moderate, heavy, and very severe. In addition, patients self-rated their overall health status using a visual analog scale (EQVAS).

  8 weeks

Secondary Outcomes (7)

• Measure Yourself Medical Outcome Profile in Chinese version (CMYMOP2)

  4 weeks

• Measure Yourself Medical Outcome Profile in Chinese version (CMYMOP2)

  8 weeks

• Modified COVID-19 Yorkshire Rehabilitation Scale (C19-YRSm)

  4 weeks

• Modified COVID-19 Yorkshire Rehabilitation Scale (C19-YRSm)

  8 weeks

• Serum level change of inflammatory factors

  4 weeks

Study Arms (2)

Traditional Chinese medicine treatment group

EXPERIMENTAL

Patients in this treatment group will receive individualized TCM syndrome differentiation treatment.

Drug: Traditional Chinese medicine treatment

Western medicine control group

ACTIVE COMPARATOR

Patients in this control group will receive conventional Western medicine symptomatic treatment from general Western medicine practitioners.

Drug: Western medicine treatment

Interventions

Traditional Chinese medicine treatment DRUG

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.

Also known as: CM group

Traditional Chinese medicine treatment group

Western medicine treatment DRUG

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.

Also known as: WM group

Western medicine control group

Eligibility Criteria

• Age: 6 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Interventions

streptococcal polysaccharide type III group B

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Hongwei Zhang, PhD

  School of Chinese Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hongwei Zhang, PhD

CONTACT

39439845; zhanghw@cuhk.edu.hk

Cho Wing Lo

CONTACT

35053476; louislo@cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome data collectors are blinded throughout the study. Patients will be specifically instructed not to disclose specific treatment received to outcome data collectors.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Model Details: 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.

Study Record Dates

• First Submitted: October 20, 2023
• First Posted: October 23, 2023
• Study Start: December 1, 2023
• Primary Completion: November 30, 2025
• Study Completion: February 28, 2026
• Last Updated: October 26, 2023

Record last verified: 2023-10