By Central Council for Research in Ayurveda and Siddha (India)
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Extra info for Clinical Research Protocols for Traditional Health Sciences: Ayurveda, Siddha, Unani, Sowa Rigpa, and Others
X. CRITERIA FOR ASSESSMENT The assessment of progress & outcome of treatment are assessed on the basis of improvement in the score of ASTHMA CONTROL QUESTIONNAIRE (Anexxure-1) and VAS (ANNEX-2) and safety evaluation will be made on the basis of serial recording of the adverse events and Liver and Kidney function tests as per recorded in the proforma II B and III. XI. , New Delhi. XII. ETHICAL REVIEW Each Institutional Ethical Committee (IEC) of participating Center’s should give clearance certificate before the project is initiated.
STATISTICAL ANALYSIS Data collected on scores of ACQ (ANNEX-1) & VAS (ANNEX-2) based on which progress of treatment will be analyzed using appropriate statistical tools. X. CRITERIA FOR ASSESSMENT The assessment of progress & outcome of treatment are assessed on the basis of improvement in the score of ASTHMA CONTROL QUESTIONNAIRE (Anexxure-1) and VAS (ANNEX-2) and safety evaluation will be made on the basis of serial recording of the adverse events and Liver and Kidney function tests as per recorded in the proforma II B and III.
Age below 18 years and more than 40 years 18. Dyspnoea due to other disease like Left ventricular failure, COPD (Chronic Bronchitis, Emphysema), Upper respiratory tract obstruction, Bronchiectasis, cases of tuberculosis, interstitial lung disease/occupational Lung disease, tropical pulmonary eosinophilia etc. 19. Uncontrolled Diabetes Mellitus and Hypertension. 20. Any other systemic disorder 21. HIV positive cases 22. Pregnant/lactating mother 23. Asthmatics that need daily Salbutamol inhaler.