Jinhua Qinggan Granules in the Treatment of COVID-19

Phase 2

Completed

• Conditions: COVID-19
• Interventions: Combination Product: Jinhua Qinggan (JHQG) Granules, Traditional Chinese Medicine; Other: Placebo Comparator

• Registration Number: NCT04723524
• Lead Sponsor: University of Karachi

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.

Study Timeline

• Study Start: 2020-09-22
• Study First Submitted: 2021-01-22
• Study First Submitted QC: 2021-01-22
• Study First Posted: 2021-01-25
• Primary Completion: 2021-08-23
• Study Completion: 2021-08-23
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-16
• Last Update Posted: 2022-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 402

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment group	Jinhua Qinggan (JHQG) Granules, Traditional Chinese Medicine	150 Cases, treated with Jinhua Qinggan (JHQG) Granules
Control group	Placebo Comparator	150 Cases, Placebo treated

Primary Outcome Measures

Name	Time	Method
Change in Primary symptom (cough)	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)	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	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

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

Trial Locations

Locations (1)

Center for Bioequivalence Studies and Clinical Research (CBSCR), ICCBS, university of Karachi; 🇵🇰 Karachi, Pakistan