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

June 16, 2022 updated by: Dr. Muhammad Raza Shah, University of Karachi

Multi-center, Randomized, Double Blind and Placebo Controlled Clinical Trial on the Effectiveness and Safety of Jinhua Qinggan Granules (JHQG) for the Treatment of COVID 19 Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 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

Enrollment (Actual)

402

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
      • Karachi, Pakistan, 75270
        • Center for Bioequivalence Studies and Clinical Research (CBSCR), ICCBS, university of Karachi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment group
150 Cases, treated with Jinhua Qinggan (JHQG) Granules
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.
Placebo Comparator: Control group
150 Cases, Placebo treated
Other: Placebo Comparator
Jinhua Qinggan granules simulation (placebo) agent: 5g/sachet; 1 sachet each time, 3 times daily after meal, dissolve in boil water.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Primary symptom (cough)
Time Frame: 10th day of treatment.
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.
10th day of treatment.
Change in Primary symptom (Fever)
Time Frame: 10th day of treatment
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).
10th day of treatment
Time for Negative COVID-19 Test
Time Frame: 2nd follow-up on 10th day or 3rd follow-up for RT-PCR test on 15th day if positive on 10th day
time for Negative coronavirus (COVID-19) Test on RT-PCR
2nd follow-up on 10th day or 3rd follow-up for RT-PCR test on 15th day if positive on 10th day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body temperature
Time Frame: 10 days
The onset time of fever and the complete time of defervescence.
10 days
white blood cells count
Time Frame: during the 10-day course of treatment
Change in white blood cells count
during the 10-day course of treatment
C-reactive protein test
Time Frame: during the 10-day course of treatment
Change in C-reactive protein level in blood
during the 10-day course of treatment
ferritin test
Time Frame: during the 10-day course of treatment
Change in ferritin level in blood
during the 10-day course of treatment
Radiology
Time Frame: during the 10-day course of treatment
Change in radiographic findings of the lungs.
during the 10-day course of treatment
Quality of life assessment:
Time Frame: during the 10-day course of treatment
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.
during the 10-day course of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Karachi

Collaborators

Indus Hospital and Health Network
Dr. Ruth K.M. Pfau Civil Hospital, Karachi
Dow University Hospital, Mission Rd, Gulzar-e-Hijri, Scheme 33, Karachi. Tel: (92-21) 38771111

Investigators

  • Principal Investigator: Muhammad Raza Shah, CBSCR , ICCBS, University of Karachi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 22, 2020

Primary Completion (Actual)

August 23, 2021

Study Completion (Actual)

August 23, 2021

Study Registration Dates

First Submitted

January 22, 2021

First Submitted That Met QC Criteria

January 22, 2021

First Posted (Actual)

January 25, 2021

Study Record Updates

Last Update Posted (Actual)

June 22, 2022

Last Update Submitted That Met QC Criteria

June 16, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRO-003-TCM- JHQG -2020/3.0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on COVID-19

Clinical Trials on Jinhua Qinggan (JHQG) Granules, Traditional Chinese Medicine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Czech Republic

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe