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.
Combination Product: Jinhua Qinggan (JHQG) Granules, Traditional Chinese Medicine
Jinhua Qinggan granules: 5g/sachet; 1 sachet each time, 3 times daily after meal, dissolve in boil water.
Other: Placebo Comparator
Jinhua Qinggan granules simulation (placebo) agent: 5g/sachet; 1 sachet each time, 3 times daily after meal, dissolve in boil water.
Inclusion Criteria:
- 1) Between the ages of 18-75 years, both male and female.
- 2) Confirmed Coronavirus infection by real time RT-PCR.
- 3) Mild cases of Coronavirus having main symptoms with minimum 2 grade (as mentioned
in 7.1.6).
- 4) The subject has signed the informed consent form;
Exclusion Criteria:
- 1) Younger than 18 years or older than 75 years.
- 2) Patients with moderate or critical Coronavirus infection confirmed by real time
RT-PCR; cases meeting any of the following criteria:
1. Lung lesions
2. Respiratory failure and requiring mechanical ventilation
3. Shock
4. With other organ failure that requires ICU cares.
- 3) Severe primary health conditions associated with cardiovascular, cerebrovascular,
pulmonary, hepatic, renal, endocrine and hematological diseases, hematopoietic system
(above grade II of cardiac function; ALT & AST are 1.5 times higher than the normal
value; Creatinine above the upper limit of normal value) and mental illness or serious
diseases affecting their survival, such as cancer or AIDS;
- 4) With severe cardiopulmonary dysfunction, cardiopulmonary insufficiency.
- 5) Subjects, who took other antiviral, antibacterial, cough relieving, expectorant and
antiasthmatic drugs within 3 days prior to the visit (including β2 receptor agonists,
anticholinergic agents, theophylline drugs, glucocorticoids, expectorant and Chinese
Medicine.)
- 6) Allergic individuals and those who are known to be allergic to experimental drugs
- 7) Pregnant women, lactating women or fertile women who are ready to conceive in 3
months.
- 8) Subject, who has participated in the past 1 month in another clinical study.
- 9) Subjects who are not suitable for the clinical trial based on investigators'
judgment.
Center for Bioequivalence Studies and Clinical Research (CBSCR), ICCBS, university of Karachi
Karachi, Pakistan
Muhammad Raza Shah, Principal Investigator
CBSCR , ICCBS, University of Karachi