Post COVID-19 Clinical Trial
Official title:
Special Chinese Medicine Out-patient Programme for Discharged COVID-19 Patients: An Observational Study
According to the ongoing observational studies and the Chinese Medicine practice guideline
for COVID-19 patients, the discharged patients with COVID-19 still exhibits certain clinical
symptoms such as fatigue, poor appetite, short of breath, palpation, and poor sleep, which
could be recognized as two main Patterns in Chinese Medicine, Qi Deficiency of Lung and
Spleen and Qi & Yin Deficiency. Based on this, pulmonary rehabilitation to improve lung
function upon discharged was proposed. Therefore, even patients with COVID-19 were discharged
from hospitals, there are symptoms with significant clinical syndromes in Chinese Medicine
perspectives. These symptoms, in terms of syndrome, which could link with the body
constitutions, could be due to pre-COVID-19 infection, suffering from infection, or a
consequence of post-infection.
This observational study is a rehabilitation programme to elucidate i) whether body
constitution is linking with the infection of COVID-19; ii) whether TCM can help the recovery
of discharged COVID-19 patients.
This is an observational multi-centered study that will be conducted in the government
subsidized tri-partite CM out-patient clinics (Chinese Medicine Clinic cum Training and
Research Centres, "CMCTRs").
The study contains two parts as follows:
1. Retrospective Syndrome Survey: Retrospective information will be collected from
participants using semi-structured interview and measuring the baseline body
constitution before the rehabilitation treatment under the Programme, with the
self-developed Body Constitutions Questionnaire.
2. TCM therapeutic assessment: The improvement of clinical symptoms and the status of body
constitutions will be periodically evaluated.
Clinical CM Diagnostic Pattern & clinical characteristics assessments, lung function tests,
quality of life and no. of western medical consultations will be assessed at each visit for 9
months. Both retrospective and prospective assessments will be done for those participants
who have already joined the Rehabilitation Program in CMCTRs.
Sample Size: Estimated at 150 participants.
Treatment of the Rehabilitation Program in CMCTRs:
The treatment is based on individual Chinese Medicine syndrome and clinical symptoms based on
the Chinese Medicine practice guideline for COVID-19 patients. Two main Chinese medicine
syndromes for patients recovered from COVID-19 with the recommended prescriptions will be
included in the Rehabilitation Program.
the participants will receive three months individualized-Chinese herbal medicine treatment
in CMCTRs. After the three months treatment, they are free to either continue another
three-month treatment or enter into the follow-up period. Each participant will be assessed
every month during the treatment and three months after treatment as follow-up.
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