Back to resultsJinhua Qinggan Granules in the Treatment of COVID-19 (RCT)
Primary Purpose
COVID-19
Status
Completed
Phase
Phase 2
Locations
Pakistan
Study Type
Interventional
Intervention
Jinhua Qinggan (JHQG) Granules, Traditional Chinese Medicine
Placebo Comparator
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19
Eligibility 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:
- 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.
Sites / Locations
- Center for Bioequivalence Studies and Clinical Research (CBSCR), ICCBS, university of Karachi
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Treatment group
Control group
Arm Description
150 Cases, treated with Jinhua Qinggan (JHQG) Granules
150 Cases, Placebo treated
Outcomes
Primary Outcome Measures
Change in Primary symptom (cough)
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.
Change in Primary symptom (Fever)
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).
Time for Negative COVID-19 Test
time for Negative coronavirus (COVID-19) Test on RT-PCR
Secondary Outcome Measures
Body temperature
The onset time of fever and the complete time of defervescence.
white blood cells count
Change in white blood cells count
C-reactive protein test
Change in C-reactive protein level in blood
ferritin test
Change in ferritin level in blood
Radiology
Change in radiographic findings of the lungs.
Quality of life assessment:
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.
Full Information
NCT ID
NCT04723524
First Posted
January 22, 2021
Last Updated
June 16, 2022
Sponsor
University of Karachi
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
1. Study Identification
Unique Protocol Identification Number
NCT04723524
Brief Title
Jinhua Qinggan Granules in the Treatment of COVID-19
Acronym
RCT
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
September 22, 2020 (Actual)
Primary Completion Date
August 23, 2021 (Actual)
Study Completion Date
August 23, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Karachi
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
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Multi-center, Randomized, Double Blind and Placebo Controlled Clinical Trial
Masking
ParticipantCare Provider
Masking Description
Double blind
Allocation
Randomized
Enrollment
402 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment group
Arm Type
Experimental
Arm Description
150 Cases, treated with Jinhua Qinggan (JHQG) Granules
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
150 Cases, Placebo treated
Intervention Type
Combination Product
Intervention Name(s)
Jinhua Qinggan (JHQG) Granules, Traditional Chinese Medicine
Intervention Description
Jinhua Qinggan granules: 5g/sachet; 1 sachet each time, 3 times daily after meal, dissolve in boil water.
Intervention Type
Other
Intervention Name(s)
Placebo Comparator
Intervention Description
Jinhua Qinggan granules simulation (placebo) agent: 5g/sachet; 1 sachet each time, 3 times daily after meal, dissolve in boil water.
Primary Outcome Measure Information:
Title
Change in Primary symptom (cough)
Description
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.
Time Frame
10th day of treatment.
Title
Change in Primary symptom (Fever)
Description
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).
Time Frame
10th day of treatment
Title
Time for Negative COVID-19 Test
Description
time for Negative coronavirus (COVID-19) Test on RT-PCR
Time Frame
2nd follow-up on 10th day or 3rd follow-up for RT-PCR test on 15th day if positive on 10th day
Secondary Outcome Measure Information:
Title
Body temperature
Description
The onset time of fever and the complete time of defervescence.
Time Frame
10 days
Title
white blood cells count
Description
Change in white blood cells count
Time Frame
during the 10-day course of treatment
Title
C-reactive protein test
Description
Change in C-reactive protein level in blood
Time Frame
during the 10-day course of treatment
Title
ferritin test
Description
Change in ferritin level in blood
Time Frame
during the 10-day course of treatment
Title
Radiology
Description
Change in radiographic findings of the lungs.
Time Frame
during the 10-day course of treatment
Title
Quality of life assessment:
Description
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.
Time Frame
during the 10-day course of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Muhammad Raza Shah
Organizational Affiliation
CBSCR , ICCBS, University of Karachi
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Bioequivalence Studies and Clinical Research (CBSCR), ICCBS, university of Karachi
City
Karachi
ZIP/Postal Code
75270
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32541475
Citation
Zhang Q, Cao F, Wang Y, Xu X, Sun Y, Li J, Qi X, Sun S, Ji G, Song B. The efficacy and safety of Jinhua Qinggan granule (JHQG) in the treatment of coronavirus disease 2019 (COVID-19): A protocol for systematic review and meta analysis. Medicine (Baltimore). 2020 Jun 12;99(24):e20531. doi: 10.1097/MD.0000000000020531.
Results Reference
background
PubMed Identifier
35979216
Citation
Shah MR, Fatima S, Khan SN, Ullah S, Himani G, Wan K, Lin T, Lau JYN, Liu Q, Lam DSC. Jinhua Qinggan granules for non-hospitalized COVID-19 patients: A double-blind, placebo-controlled, and randomized controlled trial. Front Med (Lausanne). 2022 Aug 1;9:928468. doi: 10.3389/fmed.2022.928468. eCollection 2022.
Results Reference
derived
Links:
URL
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7302627/
Description
The efficacy and safety of Jinhua Qinggan granule (JHQG) in the treatment of coronavirus disease 2019 (COVID-19): A protocol for systematic review and meta analysis. Medicine (Baltimore)
Learn more about this trial
Jinhua Qinggan Granules in the Treatment of COVID-19
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