Evaluate the Efficacy of Siddha Treatment in Patients with Novel Coronavirus Infectious Disease (COVID-19)
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
- Registration Number
- CTRI/2020/08/026999
- Lead Sponsor
- Indian Medicine and Homeopathy Department Chennai
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 100
1. Admitted with COVID-19 infection determined by RT-PCR.
2. Male , Non pregnant female above the age of 18 at the time of enrollment
3. Subject provides informed consent form in written or in digital form
4. COVID - 19 Positive with no clinical signs
5. COVID - 19 Positive with mild symptoms â?? Sneezing, Cough, Sore Throat, Throat Pain, Malaise, Tiredness, Fever, loss of smell, loss of taste
1.Pregnancy and breast feeding females
2.COVID - 19 Positive with Severe symptoms â?? Respiratory distress ( >24 breath per minute), Oxygen saturation < 95% at rest, Respiratory failure, Need of Mechanical Ventilation, Septic shock, Non respiratory organ failure
3. Chronic Renal Failure requiring dialysis (eGFR < 30)
4. Known cases of uncontrolled Diabetes ( >9% HbA1c)
5. Known cases of stage 3 Hypertension ( > 160/100 mmHg)
6. Subjects having any medical or surgical condition that would require immediate medical or surgical intervention at the time of screening
7. Subjects having immune compromised status like HIV, Hepatitis, Tuberculosis, Cancer etc.
8. Subjects taking Steroid treatment and or any kind of immunosuppressive therapy
9.Subjects who are participating in any other clinical study or having participated in any other study 1 month prior to screening in the present study.
10.Subjects with bleeding disorders and severe anemia (Hb <7)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary Outcomes <br/ ><br>Reduction in Viral load of Novel-cov2 at the end of treatment(0, 7 days) <br/ ><br>Reduction of incidence of clinical symptoms/parameters like fever, cough / oxygen rate, respiration rate, temperature, <br/ ><br>Assessment of levels of inflammatory markers like LDH, D-dimer, CRP, ferritin at the end of treatment (0, 7 days)Timepoint: 7 th day
- Secondary Outcome Measures
Name Time Method 1.Reduction in the incidence of complications. <br/ ><br>2.Reduction of in-hospital time. <br/ ><br>3.Laboratory markers <br/ ><br>4.Adverse events/effectsTimepoint: â®?7 th day