Ignite Creation Date:
2025-12-25 @ 12:08 AM
Ignite Modification Date:
2025-12-25 @ 10:08 PM
Study NCT ID:
NCT06095258
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-10-26
First Post:
2023-10-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Practical RCT of TCM in the Treatment of LCOVID and Analysis of Syndrome Types and Medication Characteristics.
Sponsor:
Chinese University of Hong Kong
Organization:
Study Overview
Official Title:
A Practical Clinical Randomized Controlled Trial of Traditional Chinese Medicine in the Treatment of Long COVID and an Analysis of Syndrome Types and Medication Characteristics of Traditional Chinese Medicine
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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).
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).
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 have reported that about 10%-20% of people will continue to have some post-infection symptoms after being infected with the new coronavirus. The World Health Organization (WHO) named it the Post COVID-19 Condition or Long COVID. The main symptoms of Long COVID include severe fatigue, shortness of breath, heart damage (such as myocarditis), cognitive impairment, sleep disturbance, post-traumatic stress disorder syndrome, muscle pain, decreased concentration, headache, impaired taste, and smell, etc.
In the face of the ongoing epidemic and more and more people being infected, people are increasingly concerned about the long-term impact of the new coronavirus infection. At present, western medicine is trying to adopt symptomatic treatment for some main symptoms of COVID-19. In addition, people are also trying many non-drug treatments, such as exercise, pulmonary rehabilitation training, cognitive behavioral therapy, etc.
Traditional Chinese medicine (TCM) has been strongly involved in the treatment and prevention of COVID-19 and the recovery of COVID-19 infection in the early stages of the epidemic. In order to cope with the fifth wave of the epidemic in Hong Kong, in April 2022, the Chinese government's Anti-epidemic Chinese Medicine Expert Group in Hong Kong launched the "Guidelines on the Rehabilitation of Traditional Chinese Medicine during the Recovery Period of Coronavirus Disease 2019 (Trial Version)". However, there is a lack of clinical research evidence that has practical guiding value for the TCM syndrome diagnosis and medication in long COVID patients. Secondly, there is a lack of reliable research evidence on the clinical effectiveness of individualized Chinese medicine treatment of long COVID. Thirdly, there is a lack of large-scale research data on patients with long COVID from clinical treatment. Fourthly, there is a lack of comparative research evidence between traditional Chinese medicine and conventional Western medicine.
Therefore, this study will be conducted in order to understand the possible advantages or disadvantages of traditional Chinese medicine compared with Western medicine; improve the efficacy of traditional Chinese medicine in the treatment of long COVID; and promote the application of traditional Chinese medicine in the field of long COVID treatment.
In the face of the ongoing epidemic and more and more people being infected, people are increasingly concerned about the long-term impact of the new coronavirus infection. At present, western medicine is trying to adopt symptomatic treatment for some main symptoms of COVID-19. In addition, people are also trying many non-drug treatments, such as exercise, pulmonary rehabilitation training, cognitive behavioral therapy, etc.
Traditional Chinese medicine (TCM) has been strongly involved in the treatment and prevention of COVID-19 and the recovery of COVID-19 infection in the early stages of the epidemic. In order to cope with the fifth wave of the epidemic in Hong Kong, in April 2022, the Chinese government's Anti-epidemic Chinese Medicine Expert Group in Hong Kong launched the "Guidelines on the Rehabilitation of Traditional Chinese Medicine during the Recovery Period of Coronavirus Disease 2019 (Trial Version)". However, there is a lack of clinical research evidence that has practical guiding value for the TCM syndrome diagnosis and medication in long COVID patients. Secondly, there is a lack of reliable research evidence on the clinical effectiveness of individualized Chinese medicine treatment of long COVID. Thirdly, there is a lack of large-scale research data on patients with long COVID from clinical treatment. Fourthly, there is a lack of comparative research evidence between traditional Chinese medicine and conventional Western medicine.
Therefore, this study will be conducted in order to understand the possible advantages or disadvantages of traditional Chinese medicine compared with Western medicine; improve the efficacy of traditional Chinese medicine in the treatment of long COVID; and promote the application of traditional Chinese medicine in the field of long COVID treatment.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: