COVID-19
Conditions
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.
Interventions
COMBINATION_PRODUCTJinhua Qinggan (JHQG) Granules, Traditional Chinese Medicine
Jinhua Qinggan granules: 5g/sachet; 1 sachet each time, 3 times daily after meal, dissolve in boil water.
OTHERPlacebo Comparator
Jinhua Qinggan granules simulation (placebo) agent: 5g/sachet; 1 sachet each time, 3 times daily after meal, dissolve in boil water.
Sponsors
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
University of Karachi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Masking description
Double blind
Intervention model description
Multi-center, Randomized, Double Blind and Placebo Controlled Clinical Trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| ferritin test | during the 10-day course of treatment | Change in ferritin level in blood |
| Body temperature | 10 days | The onset time of fever and the complete time of defervescence. |
| 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. |
| Radiology | during the 10-day course of treatment | Change in radiographic findings of the lungs. |
| white blood cells count | during the 10-day course of treatment | Change in white blood cells count |
| C-reactive protein test | during the 10-day course of treatment | Change in C-reactive protein level in blood |
Countries
Pakistan
Outcome results
None listed