The clinical trial is designed to be randomized, double blind, placebo controlled, to evaluate the effectiveness and safety of Jinhua Qinggan granules (JHQG) on mild-category patients of COVID-19 in Pakistani population with the age limit of 18-75 years, at10th day comprehensive follow-up. The informed consent form must be signed by the subjects before their participation in the trial.
The course of treatment is 10 days, and the visit points are set on the 1st and 10th day, in which 10th day is follow-up. Patients will be assessed by using seven-category ordinal scale and clinical signs and symptoms on 1st and 10th day. If the subject recovers and checks out within 10 days, they will be recorded once before checking out. All effectiveness and safety inspection items will be done once before the trial and once at follow-up point i.e. 10th day. In case of any new abnormality or abnormality aggravation after the treatment, should be followed up until normal or stable.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
402
Jinhua Qinggan granules: 5g/sachet; 1 sachet each time, 3 times daily after meal, dissolve in boil water.
Jinhua Qinggan granules simulation (placebo) agent: 5g/sachet; 1 sachet each time, 3 times daily after meal, dissolve in boil water.
Center for Bioequivalence Studies and Clinical Research (CBSCR), ICCBS, university of Karachi
Karachi, Pakistan
Change in Primary symptom (cough)
A grading symptom from 0-6 will be used to assess the symptom (Cough) where the score will be 0 for No cough, 2 for Intermittent cough, 4 for Cough mildly impacting the daily work and 6 Frequent cough or paroxysmal cough seriously impacting the work and life.
Time frame: 10th day of treatment.
Change in Primary symptom (Fever)
A grading symptom from 0-6 will be used to assess the improvement of main clinical symptom (Fever) where the score will be 0 for No fever ≤ 37 °C (98.6°F), 2 for body temperature \> 37°C (98.6°F) to ≤ 38°C (100.4°F), 4 for body temperature \> 38°C (100.4°F) to ≤ 39°C (102.2°F) and 6 for body temperature \> 39°C (102.2°F) to ≤ 40°C (104°F).
Time frame: 10th day of treatment
Time for Negative COVID-19 Test
time for Negative coronavirus (COVID-19) Test on RT-PCR
Time frame: 2nd follow-up on 10th day or 3rd follow-up for RT-PCR test on 15th day if positive on 10th day
Body temperature
The onset time of fever and the complete time of defervescence.
Time frame: 10 days
white blood cells count
Change in white blood cells count
Time frame: during the 10-day course of treatment
C-reactive protein test
Change in C-reactive protein level in blood
Time frame: during the 10-day course of treatment
ferritin test
Change in ferritin level in blood
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Time frame: during the 10-day course of treatment
Radiology
Change in radiographic findings of the lungs.
Time frame: during the 10-day course of treatment
Quality of life assessment:
The quality of life of the product will be assessed by using the Patient's Quality of Life Assessment Questionnaire (QOL). The QOL questionnaire is divided into three parts: Psychology, Physiology, and Society. The score of each section is calculated by the sum of score of the part divided by the number of questions. The total is the sum of the three parts, and the minimum importance difference (MID) is 1.3, which means that if the QOL questionnaire score before and after treatment in the same patient rises by 1.3, it indicates that the treatment is effective. At the same time, the higher the QOL score, the lighter the illness is.
Time frame: during the 10-day course of treatment