Jinhua Qinggan Granules in the Treatment of COVID-19

COVID-19 Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04723524
• Other study ID #: CRO-003-TCM- JHQG -2020/3.0
• Status: Completed
• Phase: Phase 2
• Start date: September 22, 2020
• Est. completion date: August 23, 2021

Study information

• Verified date: June 2022
• Source: University of Karachi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 402
• Est. completion date: August 23, 2021
• Est. primary completion date: August 23, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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 ß2 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.

Related Conditions & MeSH terms

• COVID-19

Intervention

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.

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

Locations

Country	Name	City	State
Pakistan	Center for Bioequivalence Studies and Clinical Research (CBSCR), ICCBS, university of Karachi	Karachi

Sponsors (4)

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

Country where clinical trial is conducted

Pakistan, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	10th day of treatment.
Primary	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).	10th day of treatment
Primary	Time for Negative COVID-19 Test	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	Body temperature	The onset time of fever and the complete time of defervescence.	10 days
Secondary	white blood cells count	Change in white blood cells count	during the 10-day course of treatment
Secondary	C-reactive protein test	Change in C-reactive protein level in blood	during the 10-day course of treatment
Secondary	ferritin test	Change in ferritin level in blood	during the 10-day course of treatment
Secondary	Radiology	Change in radiographic findings of the lungs.	during the 10-day course of treatment
Secondary	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.	during the 10-day course of treatment

External Links

•   Exploring the active components and mechanism of Jinhua Qinggan Granules in treatment of coronavirus disease 2019 (COVID-19) based on network pharmacology and molecular docking technology
•   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)