Jinhua Qinggan Granules in the Treatment of COVID-19 (RCT)

University of Karachi

Status and phase: Completed; Phase 2

Conditions: COVID-19

Treatments: Other: Placebo Comparator; Combination Product: Jinhua Qinggan (JHQG) Granules, Traditional Chinese Medicine

Study type: Interventional

Funder types: Other

Identifiers

NCT04723524

CRO-003-TCM- JHQG -2020/3.0

Details and patient eligibility

About

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.

Full 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 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.

Enrollment: 402 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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402 participants in 2 patient groups, including a placebo group

Treatment group

Experimental group

Description:

150 Cases, treated with Jinhua Qinggan (JHQG) Granules

Treatment:

Combination Product: Jinhua Qinggan (JHQG) Granules, Traditional Chinese Medicine

Control group

Placebo Comparator group

Description:

150 Cases, Placebo treated

Treatment:

Other: Placebo Comparator