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
Dl) _______________ 18. Globulin (g. /dl) _______________ 19. A/G Ratio _______________ 20. S. Bilirubin (mg. /dL) Total Direct Indirect 21. SGPT. (IU/L) 22. SGOT (IU/L) 23. Alk. Phosphates (KA units) _______________ 24. X-ray chest PA View (‘0’ WEEK only) 25. ECG (0, 4 week & if symptoms suggest sos) 26. Any other Remarks _________________________________________________ Date: ________________ Signature of the Investigator: _______________________ 30 ASSESSMENT OF SAFETY AND THERAPEUTIC EFFICACY OF SHIRISHADI KWATHA IN THE MANAGEMENT OF MILD PERSISTENT ASTHMA (TAMAKA SHWASA) Drug: Study Code: PROTOCOL & CASE REPORT FORMS (CRF) CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA 31 Blank 32 CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA ASSESSMENT OF SAFETY AND THERAPEUTIC EFFICACY OF SHIRISHADI KWATHA IN THE MANAGEMENT OF MILD PERSISTENT ASTHMA (TAMAKA SHWASA) I.
Educational status: Illiterate (1) 9. A. (8) Field work (2) Occupation: Desk work(1) Field work with physical labour (3) Field work with intellectual (4) (6) Indicate nature of work: ........................................................................... 10. ): ____________________________ of the participant and Head of the family Chief complaints with duration (in days) Yes (1) 11. Cough (Dry/Productive) 13 No (0) Duration (in days) 12. Sputum - Thick and scanty/Mucoid/ Mucopurulent/Streaks with blood 13.
Haffkine Institute, Bombay 6. , New Delhi. 33 II. OBJECTIVE Primary Objective: To evaluate the comparative efficacy of Shireeshadi kwatha & sustained-release theophylline in the mild persistent asthma. Secondary Objective: To evaluate the safety of Shireeshadi kwatha in the patients of mild persistent asthma. III. CENTRE: CCRAS centers in collaboration with other centers IV. SAMPLE SIZE AND METHODS Sample Size: 250 (125 patients in each group) Treatment: A. ). B. Treatment period: 1. ) contains Albizzia Lebbeck (Shirish) , Solanum Surattence (Kantkari), Adhatoda Vasica leaves (Vasa), Hedychium Spicatum (Shati) and equal in quantity.