Jinhua Qinggan Granules in the Treatment of COVID-19 (RCT)
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|ClinicalTrials.gov Identifier: NCT04723524|
Recruitment Status : Completed
First Posted : January 25, 2021
Last Update Posted : June 22, 2022
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|Condition or disease||Intervention/treatment||Phase|
|COVID-19||Combination Product: Jinhua Qinggan (JHQG) Granules, Traditional Chinese Medicine Other: Placebo Comparator||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||402 participants|
|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|
|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|
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.
- 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.
- 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).
- 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
- Body temperature [ Time Frame: 10 days ]The onset time of fever and the complete time of defervescence.
- white blood cells count [ Time Frame: during the 10-day course of treatment ]Change in white blood cells count
- C-reactive protein test [ Time Frame: during the 10-day course of treatment ]Change in C-reactive protein level in blood
- ferritin test [ Time Frame: during the 10-day course of treatment ]Change in ferritin level in blood
- Radiology [ Time Frame: during the 10-day course of treatment ]Change in radiographic findings of the lungs.
- 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.
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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|
- 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;
- 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
- 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.
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
|Center for Bioequivalence Studies and Clinical Research (CBSCR), ICCBS, university of Karachi|
|Karachi, Pakistan, 75270|
|Principal Investigator:||Muhammad Raza Shah||CBSCR , ICCBS, University of Karachi|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||Dr. Muhammad Raza Shah, Professor, University of Karachi|
|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|
|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|
Respiratory Tract Infections
RNA Virus Infections
Respiratory Tract Diseases