Jinhua Qinggan Granules in the Treatment of COVID-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

402 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-22

Study Completion Date

2021-08-23

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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COVID-19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Multi-center, Randomized, Double Blind and Placebo Controlled Clinical Trial

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Double blind

Study Groups

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Treatment group

150 Cases, treated with Jinhua Qinggan (JHQG) Granules

Group Type EXPERIMENTAL

Jinhua Qinggan (JHQG) Granules, Traditional Chinese Medicine

Intervention Type COMBINATION_PRODUCT

Jinhua Qinggan granules: 5g/sachet; 1 sachet each time, 3 times daily after meal, dissolve in boil water.

Control group

150 Cases, Placebo treated

Group Type PLACEBO_COMPARATOR

Placebo Comparator

Intervention Type OTHER

Jinhua Qinggan granules simulation (placebo) agent: 5g/sachet; 1 sachet each time, 3 times daily after meal, dissolve in boil water.

Interventions

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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.

Intervention Type COMBINATION_PRODUCT

Placebo Comparator

Jinhua Qinggan granules simulation (placebo) agent: 5g/sachet; 1 sachet each time, 3 times daily after meal, dissolve in boil water.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No