CTRI/2020/10/028491Not yet recruitingPhase 2
PhaseII non randomized clinical study on sooli kanam (Bronchial asthma) with evaluation of siddha trial drug - Kannaiku atthi nei
Government siddha medical college chennai1 site in 1 country40 target enrollmentStarted: October 25, 2020Last updated:
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- clinical assesment of bronchial asthma is carried out on the basis of modified asthma scale, and comparing the clinical symptoms before and after treatment
Study Overview
Brief Summary
This is an phase II open single non randomized study to evaluate the official Siddha formulaiton "Kannaiku atthi nei" internally for Bronchial asthma (sooli kanam) . The trial drug is given 2 to 5 ml twice a day for 21 days. clinical trial conducted after conducting pre-clinical toxicity study. The trial drug Kannaiku atthi nei is mentioned in kumbamuni balavagadam book. During the trial study related data will be recorded and documented. after the completion of the trial all the data will be analysed statistically.
Study Design
- Study Type
- Interventional
- Allocation
- Not Applicable
- Masking
- Not Applicable
Eligibility Criteria
- Ages
- 3.00 Year(s) to 12.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •age 3 to 12 years cough without expulsion wheezing dyspnea rhinitis.
Exclusion Criteria
- •primary complex hypersensitivity pneumonitis lung abscess cystic fibrosis bronchiolitis.
Outcomes
Primary Outcomes
clinical assesment of bronchial asthma is carried out on the basis of modified asthma scale, and comparing the clinical symptoms before and after treatment
Time Frame: 21 days
Secondary Outcomes
- it is assessed by comparing the safety parameters before and after treatment(21 days)
Investigators
Study Sites (1)
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