Clinical Trial Details (PDF Generation Date :- Fri, 12 Apr 2019 04:54:41 GMT) CTRI Number Last Modified On 03/12/2018 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2014/01/004283 [Registered on: 06/01/2014] - Trial Registered Retrospectively No Interventional Unani Single Arm Trial To evaluate the Safety and efficacy of Unani formulations in the treatment of (Pustules/Boils) Validation of Unani Pharmacopoeial formulations in Busoor-e-Jild (Pustules/Boils) Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) Details Contact Person (Scientific Query) NIL Designation Affiliation NIL Details of Principal Investigator Dr Abdul Hannan Joint Director Phone 01128521981 Fax 01128522965 Email Designation Affiliation Central Council for Research in Unani Medicine (CCRUM), Delhi Central Council for Research in Unani Medicine (CCRUM), Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri, New Delhi South DELHI 110058 ccrum605@gmail.com Details Contact Person (Scientific Query) Dr Abdul Hannan Joint Director Central Council for Research in Unani Medicine (CCRUM), Delhi Central Council for Research in Unani Medicine (CCRUM), Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri, New Delhi Details Contact Person (Public Query) DELHI 110058 Phone 01128521981 Fax 01128522965 Email ccrum605@gmail.com Details Contact Person (Public Query) Dr Abdul Hannan page 1 / 7
Designation Affiliation Joint Director Central Council for Research in Unani Medicine (CCRUM), Delhi Central Council for Research in Unani Medicine (CCRUM), Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri, New Delhi Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Details of Ethics Committee DELHI 110058 Phone 01128521981 Fax 01128522965 Email ccrum605@gmail.com Source of Monetary or Material Support > Infrastructural support : 1. Regional Research Institute of Unani Medicine(RRIUM), BHADRAK 2. Regional Research Centre, Allahabad 3. Clinical Research Unit, Burhanpur Monetary Support : Central Council for Research in Unani Medicine (CCRUM), New Delhi Type of Sponsor nil List of Countries of Principal Investigator Dr Mujahid Sami Dr Zubair Ahmad Khan DR MAHE ALAM Primary Sponsor Details Central Council for Research in Unani Medicine CCRUM New Delhi Delhi-110058 Research institution of Site Site Phone/Fax/Email Clinical Research Unit, Burhanpur Regional Research Centre Allahabad Regional Research Institute of Unani Medicine, Bhadrak Ganpati Naka Burhanpur West Nimar MADHYA PRADESH B- 501/4, G.T.B. Nagar ( Opp. Dulhan Place) Allahabad Allahabad UTTAR PRADESH Motel Chhak, Mathasahi, Bhadrak-756100 (Odisha) Bhadrak ORISSA 09827541428 mahajankk@rediffmail.c om 05322551808 05322655105 rrcallahabad@gmail.co m 06784240289 06784240289 mahealam_234@yahoo.co.in of Committee Approval Status Date of Approval Is Independent Ethics Committee? CRU, Burhanpur, Institutional Ethics Committee, Burhanpur, Approved 30/03/2013 No page 2 / 7
Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Inclusion Criteria M.P. Dr. Mujahid Sami, Principal Investigator RRC, Allahabad, Institutional Ethics Committee, Allahabad U.P., Dr. Zubair Ahmad Khan, Principal Investigator RRIUM Bhadrak Institutional Ethics Committee, Bhadrak, Dr. Mahe Alam, Principal Investigator Status Health Type Approved 13/03/2013 No Approved 15/03/2013 No Date No Date Specified Condition Patients Busoor-e-Jild (Pustules/Boils) Patients Other specified local infections of the skin and subcutaneous tissue Type Details Intervention 1. Majoon-e-Ushba 2.Arq Murakkab Musaffi Khoon Comparator Agent NIL NIL Age From Age To Gender Details 5.00 Year(s) 60.00 Year(s) Both Inclusion Criteria 1. Majoon-e-Ushba - 12gm orally daily 2.Arq Murakkab Musaffi Khoon - 25 ml orlly twice daily Both the agents are being given to the same patient Duration of therapy : 06 weeks 1. Patients of either sex in the age group of 5 to 60 years. 2. Frequent occurrence of the following 3. Vesicles (a vesicle is a small blister, as on the skin. Vesicles are less than.5 centimeters in diameter) 4. Papules (Small solid rounded bumps rising from the skin that are each usually less than 1 centimeter in diameter (less than 3/8 inch across) 5. Pustules (Small solid rounded bumps rising from the skin that are each usually less than 1 centimeter in diameter (less than 3/8 inch across) 6. Macules (Flat, distinct, colored area of the skin less than 1 cm in diameter) Exclusion Criteria Method of Generating Random Sequence Method of Details Exclusion Criteria 1. Age 5 years and 60 years 2. Patients with diseases/ disorders requiring long term treatment 3. Patients with Diabetes mellitus 4. Patients with other inflammatory skin conditions like localized abscess/ carbuncles/ boils. 5. Pregnancy and Lactation page 3 / 7
Concealment Blinding/Masking Primary Outcome Outcome Timepoints Improvement in signs and symptoms 6 WEEKS Secondary Outcome Outcome Timepoints Hematological and biochemical assessments for safety 6 WEEKS Target Sample Size Phase of Trial Phase 2 Date of First Enrollment () Date of First Enrollment (Global) Estimated Duration of Trial Recruitment Status of Trial (Global) Recruitment Status of Trial () Publication Details Brief Summary Total Sample Size=300 Sample Size from =300 02/11/2011 No Date Specified Years=2 Months=0 Days=0 Open to Recruitment NIL This study is designed as a multicentric open trial in patients with Busoor-e-Jild (Pustules/Boils) After screening, Patients will be enrolled if they satisfy inclusion and exclusion criteria. The clinical follow-up will be carried out weekly for the 1st month and every 2 weeks for the rest of the study.this includes subjective assessment of general well being and physical examination. The total duration of treatment will be 06 weeks.. Laboratory parameters for safety assessment will be conducted at baseline and end of study. Composition of Majoon-e-Usba 1. Sana 80 g 2. Sandal Surakh 60 gm. 3. Sandal Safaid 60 gm. 4. Chobchini 60 gm. page 4 / 7
5. Gul-e-Surkh 60 gm. 6. Darchini 40 gm. 7. Kababchini 40 gm. 8. Gaozaban 40 gm. 9. Atimoon 40 gm. 10. Bisfayaj 40 gm. 11. Post-e-Balela 20 gm. 12. Sumbul-ut-Teeb 20 gm. 13. Halela Siyah 15 gm. 14. Post-e-Halela Zard 10 gm. 15. Asal OR Qand Safaid 2 kg. Sharbat Murakkab Musaffi Khoon 1. Burada Aabnoos 50 g. 2. Burada Sheesham 50 g. 3. Burada Sandal Surkh 100 g. page 5 / 7
4. Burada Sandal Safaid. 5. Barg e Hina 6. Barg e Neem 2 7. Brahm dandi 8. Post Halela Zard. 9. Chiraita talkh 50 g. 10. Sarphoka 50 g. 11. Shahtara 100 g 12. Unnab 250 g. 13. Gul Mundi 14. Gul Neelofer 15. Neel Kanthi 16. Halela Siyah neem Kofta page 6 / 7
Powered by TCPDF (www.tcpdf.org) 17. Water 5ltrs page 7 / 7