Status:
COMPLETED
Jinhua Qinggan Granules in the Treatment of COVID-19
Lead Sponsor:
University of Karachi
Collaborating Sponsors:
Indus Hospital and Health Network
Dow University Hospital, Mission Rd, Gulzar-e-Hijri, Scheme 33, Karachi. Tel: (92-21) 38771111
Conditions:
COVID-19
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
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 P...
Detailed Description
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 s...
Eligibility Criteria
Inclusion
- 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
- 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:
- Lung lesions
- Respiratory failure and requiring mechanical ventilation
- Shock
- 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.
Key Trial Info
Start Date :
September 22 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 23 2021
Estimated Enrollment :
402 Patients enrolled
Trial Details
Trial ID
NCT04723524
Start Date
September 22 2020
End Date
August 23 2021
Last Update
June 22 2022
Active Locations (1)
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1
Center for Bioequivalence Studies and Clinical Research (CBSCR), ICCBS, university of Karachi
Karachi, Pakistan, 75270