An Ayush healthcare initiative to improve immunity status through bala raksha kit in pediatric age group
Phase 3
- Registration Number
- CTRI/2022/05/042475
- Lead Sponsor
- Director ALL INDIA INSTITUTE OF AYURVEDA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. Age 5-10 yr of both sexes.
2. Paediatric subjects will be selected irrespective of the socioeconomic status.
3. Those who are willing to participate in the study.
4. Written informed assent/consent is documented.
Exclusion Criteria
1. Suffering from any other systemic illness and infectious disease, Severe malnutrition
2. Those who are not able to come for regular follow ups.
3. Those who are not willing to participate in the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Morbidity incidence reduction <br/ ><br>2. Sustain of Seropositivity (Quantitative analysis) <br/ ><br>3. Incidence/IgG positivity of COVID-19 in Seronegative participantsTimepoint: baseline, 03 months, 06 months <br/ ><br> <br/ ><br>
- Secondary Outcome Measures
Name Time Method 1. Changes of Natural Killer cell activity <br/ ><br>2. Changes of Cytokines (Inspection item pro-inflammatory <br/ ><br>cytokines-IL-1, IL-6, IL-18, IL-33, anti-inflammatory cytokines-IL-37, IL-38 TNF-α, Th1, <br/ ><br>Th2) <br/ ><br>3. Changes in Serum IgA, IgE, IgM, and IgG responses <br/ ><br>4. Changes in Biochemical parameters-CBC, Hb, ESR, LFT, KFT, Lipid profile, CRP, CD-4, CD-8 Cytotoxic T-cell function tests. <br/ ><br>5. Improvement in Anthropometric parameters (Weight, Height, MUAC, Skinfold thickness)Timepoint: baseline, 03 months, 06 months <br/ ><br>