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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04723524
Recruitment Status : Completed
First Posted : January 25, 2021
Last Update Posted : June 22, 2022
Sponsor:
Collaborators:
Indus Hospital and Health Network
Dow University Hospital, Mission Rd, Gulzar-e-Hijri, Scheme 33, Karachi. Tel: (92-21) 38771111
Dr. Ruth K.M. Pfau Civil Hospital, Karachi
Information provided by (Responsible Party):
Dr. Muhammad Raza Shah, University of Karachi

Study Description
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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 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.

Condition or disease Intervention/treatment Phase
COVID-19 Combination Product: Jinhua Qinggan (JHQG) Granules, Traditional Chinese Medicine Other: Placebo Comparator Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 402 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Multi-center, Randomized, Double Blind and Placebo Controlled Clinical Trial
Masking: Double (Participant, Care Provider)
Masking Description: Double blind
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : September 22, 2020
Actual Primary Completion Date : August 23, 2021
Actual Study Completion Date : August 23, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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).

  3. 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


Secondary Outcome Measures :
  1. Body temperature [ Time Frame: 10 days ]
    The onset time of fever and the complete time of defervescence.

  2. white blood cells count [ Time Frame: during the 10-day course of treatment ]
    Change in white blood cells count

  3. C-reactive protein test [ Time Frame: during the 10-day course of treatment ]
    Change in C-reactive protein level in blood

  4. ferritin test [ Time Frame: during the 10-day course of treatment ]
    Change in ferritin level in blood

  5. Radiology [ Time Frame: during the 10-day course of treatment ]
    Change in radiographic findings of the lungs.

  6. 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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04723524


Locations
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Pakistan
Center for Bioequivalence Studies and Clinical Research (CBSCR), ICCBS, university of Karachi
Karachi, Pakistan, 75270
Sponsors and Collaborators
University of Karachi
Indus Hospital and Health Network
Dow University Hospital, Mission Rd, Gulzar-e-Hijri, Scheme 33, Karachi. Tel: (92-21) 38771111
Dr. Ruth K.M. Pfau Civil Hospital, Karachi
Investigators
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Principal Investigator: Muhammad Raza Shah CBSCR , ICCBS, University of Karachi
More Information
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Additional Information:

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Dr. Muhammad Raza Shah, Professor, University of Karachi
ClinicalTrials.gov Identifier: NCT04723524    
Other Study ID Numbers: CRO-003-TCM- JHQG -2020/3.0
First Posted: January 25, 2021    Key Record Dates
Last Update Posted: June 22, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases