CTRI/2021/05/033713
Completed
Phase 2
Clinical Evaluation of Immunomodulatory Effect of Swarnaprashan in Children: A Prospective Open Label Study
ational Institute of Ayurveda Jaipur Rajasthan0 sites30 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- ational Institute of Ayurveda Jaipur Rajasthan
- Enrollment
- 30
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Children aged from 2\-5 years of either sex
- •2\. Childern with recurrent respiratory infections
- •3\. Childern with recurrent G.I.T. diseases
- •4\. Children with recurrent fever
- •5\. Children with recuurent episodes of diarrhea
- •6\. Children with other recurrent diseases
Exclusion Criteria
- •1\. Subjects suffering from major systemic illness necessitating long term treatment
- •2\. Subjects with evidence of malignancy
- •3\. Subject with aspartate amino transferase(AST) and or alanine amino transferase ALT \>3 Times of the upper normal limit and renal dysfunction (Sr. creatinine \>1\.2mg/dl), uncontrolled pulmonary dysfunction( asthmatic and COPD patients) .
- •4\. Co\-morbidity like TB, UTI and bleeding disorders etc
- •5\. Congenital anomalies and hereditary disease.
- •6\. Pulmonary or abdominal tuberculosis.
- •7\. H/O hypersensitivity to any of the trial drug or any of its ingredients.
- •8\. Subjects who have completed participation in any other clinical trial during the past six months.
- •9\. Any contraindications mentioned for Lehan karma in Kashyap Samhita.
Outcomes
Primary Outcomes
Not specified
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