Validation of immune booster potential of Kabasura Kudineer
- Registration Number
- CTRI/2020/11/029137
- Lead Sponsor
- Central Council for Research in Siddha
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1. Adult Male or Female subjects above the age of 18 years to 68 years
2.Subjects who are found to be COVID negative at the time of study recruitment and from healthcare sector
3. Subjects who are ready to provide written or digital informed consent and who are willing to participate and follow the protocol requirements of the clinical study
1. Subjects with uncontrolled diabetes and hypertension
2. Subjects who has chronic respiratory diseases with oxygen saturation
3. Severe liver disease underlying liver cirrhosis or alanine aminotransferase elevated over 5 times
4. Known allergy or hypersensitivity to study drug
5. Known severe renal impairment creatinine clearance or having received continuous renal replacement therapy hemodialysis or peritoneal dialysis
6. Pregnant or lactating women
7. Subjects having any medical or surgical condition that would require immediate medical or surgical intervention at the time of screening
8. Subjects having immune compromised status like HIV Hepatitis Tuberculosis Cancer etc based on their clinical records
9. Subjects taking Steroid treatment and or any kind of immunosuppressive therapy
10. Subjects participating in any other clinical study or having participated in any other study 1 month prior to screening in the present study.
11. Subjects having a past history of allergy to any medicine that is part of the Siddha intervention.
12. Other conditions which in the opinion of the investigators makes the patient unsuitable for enrolment or could interfere with his participation in and completion of the protocol
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Comparative assessment of occurrence of COVID-19 infection in healthy volunteers taking Kabasura kudineer with control arm administered with lemon water <br/ ><br>Timepoint: 1st week 2nd week 3rd week 4th week <br/ ><br>
- Secondary Outcome Measures
Name Time Method Comparative assessment in subjects taking Siddha drug- Kabasura kudineer and those taking lemon waterin the following <br/ ><br>1. Total blood count liver and renal function test <br/ ><br>2. Levels of TH1 cell mediated immune markers <br/ ><br>3. Levels of TH2 humoral immune response markers <br/ ><br>4. Functional assay marker for inflammatory cytokine release <br/ ><br>5. Level of Inflammatory marker <br/ ><br>6. Level of Anti Covid IgG antibodyTimepoint: 1st week 4th week