Clinical Trial Details (PDF Generation Date :- Fri, 26 Oct 2018 15:38:53 GMT) CTRI Number Last Modified On 13/03/2015 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2015/03/005638 [Registered on: 16/03/2015] - Trial Registered Prospectively No Interventional Unani Single Arm Trial To evaluate the Safety and efficacy of two Unani formulations Majun Jograj Gugal and Raughan-e-Malkangani in Waja al-mafasil (Rheumatoid Arthritis) Clinical Validation of Unani Pharmacopoeial formulations Majun Jograj Gugal and Raughan-e-Malkangani in Waja al-mafasil (Rheumatoid Arthritis) Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) Details Contact Person (Scientific Query) Details Contact Person (Public Query) WM/RA/MJGRM CLNVAL/CCRUM 14-15 Designation Affiliation Protocol Number Details of Principal Investigator PROF RAIS UR RAHMAN DIRECTOR GENERAL Phone 01128521981 Fax Email Designation Affiliation Phone 9810161758 Fax Email Designation Affiliation Central Council for Research in Unani Medicine (CCRUM) Janakpuri West DELHI 110058 drrahman002@gmail.com Details Contact Person (Scientific Query) DR KHALID M SIDDIQUI DEPUTY DIRECTOR GENERAL Central Council for Research in Unani Medicine (CCRUM) Janakpuri West DELHI 110058 ccrum507@gmail.com Details Contact Person (Public Query) DR PRADEEP KUMAR RESEARCH OFFICER SCIENTIST III Central Council for Research in Unani Medicine (CCRUM) Janakpuri West DELHI page 1 / 6
Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Details of Ethics Committee Regulatory Clearance Status from DCGI Health Condition / Problems Studied 110058 Phone 01128521981 Fax Email drpradeepkumar2001@gmail.com Source of Monetary or Material Support > Infrastructural support 1.Central Research Institute, Lucknow 2.Regional Research Institute of Unani Medicine Patna, 3.Clinical Research Unit, Kurnool Monetary Support : Central Council for Research in Unani Medicine, New Delhi Type of Sponsor nil List of Countries of Principal Investigator DR A V ALVI DR MOHD TARIQ KHAN DR WASIM AHMAD Primary Sponsor Details Central Council for Research in Unani Medicine New Delhi Janakpuri, New Delhi-110058. Research institution NA of Site Site Phone/Fax/Email Central Research Institute, Lucknow Clinical Research Unit Regional Research Institute of Unani Medicine (RRIUM), Patna C-39, MAAKAILA SECTOR C, SITAPUR ROAD YOGNA, LALA LATPAT RAI WARD Lucknow UTTAR PRADESH CANTONMENT GENERAL HOSPITAL, BEGUM BRIDGE (SOTI GANJ) Meerut UTTAR PRADESH Guzri, Patna City Patna BIHAR 09455282012 abalvi@rediffmail.com 08266001184 doctormtk@gmail.com 09555904810 mwasimahmed95@gm ail.com of Committee Approval Status Date of Approval Is Independent Ethics Committee? Central Research Institute, Lucknow Clinical Research Unit Regional Research Institute of Unani Medicine (RRIUM), Patna Status Not Applicable Health Type Patients Submittted/Under Review Submittted/Under Review No No Approved 04/12/2014 No Date Condition Waja al-mafasil (Rheumatoid Arthritis) page 2 / 6
Intervention / Comparator Agent Inclusion Criteria Type Details Intervention Majun Jograj Gugal and Raughan-e-Malkangani Comparator Agent nil NA Age From Age To Gender Details 18.00 Year(s) 65.00 Year(s) Both Inclusion Criteria 1.Majun Jograj Gugal: Dose five grams twice daily orally after meals for a period of 12 weeks 2.Raughan-e-Malkangani: Dose- Quantity sufficient local application on the affected joint (Lukewarm application on affected joint) for a period of 12 weeks Patients of either sex in the age group 18-65 years. Patients having Waja al-mafasil (rheumatoid arthritis) as defined by the following ACR-EULAR criteria (Annexure IV): 1) Definite clinical synovitis (pain, swelling, tenderness) in at least 1 joint 2) Absence of an alternative diagnosis for the observed synovitis (arthritis) 3) A total score of at least 6 from the individual scores in 4 domains: a. Number and site of involved joints (range 0-5) b. Serological abnormalities (range 0-3) c. Elevated acute-phase reactants (range 0-1) d. Duration of symptoms (range 0-1) Exclusion Criteria Details Exclusion Criteria Rheumatoid arthritis with extra-articular manifestations, joint deformities, and advanced radiological lesions (e.g. joint subluxation and collapse). Obese subjects (BMI?30) History or clinical evidence of any systemic inflammatory condition other than RA such as, juvenile chronic arthritis, spondyloarthropathy, IBD, psoriatic arthritis, active vasculitis, or gout that may interfere with evaluation. History or clinical evidence of any serious systemic illness, DM, TB, disseminated/ complicated herpes zoster (e.g., multi-dermatomal involvement, ophthalmic zoster, CNS involvement, or post-herpetic neuralgia), HIV infection or any other serious and/ or unstable illness that, in the opinion of the investigator, could constitute a risk when taking study drug or could interfere with the interpretation of data. Are currently receiving or have received intra-articular treatment (e.g., corticosteroids or hyaluronic acid), oral or parenteral corticosteroids, or NSAIDs within 2 weeks of study entry and DMARDs or IFN therapy within 4 weeks prior to study entry or are anticipated to require IFN therapy during the study. Screening laboratory test values, including SGOT, SGPT, ALP, S. creatinine, B. urea, and uric acid outside the reference range (raised >3 times the ULN) that, in the opinion of the investigator, could pose an unacceptable risk to the participant. History of hypersensitivity to study drug or any of its ingredients. Pregnant and lactating women H/o Addiction (alcohol, drugs) Method of Generating Random Sequence Not Applicable page 3 / 6
Method of Concealment Blinding/Masking Primary Outcome Outcome Timepoints Improvement in signs and symptoms of Waja al-mafasil (Rheumatoid Arthritis) 12 WEEKS Secondary Outcome Outcome Timepoints Haematological and biochemical assessments for safety? Improvement in the feeling of well-being of the patient 12 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 01/04/2015 Years=2 Months=0 Days=0 Not Applicable Not Yet Recruiting nil This study is designed as a multicentric open trial in patients with Waja al-mafasil (Rheumatoid Arthritis). Patients will receive the study drug Majun Jograj Gugal as oral and Raughan-e-Malkangani as local application twice daily for a period 12 weeks. All the laboratory parameters will be recorded at baseline and at the end of the study. Composition of Majun Jograj Gugal (NFUM-I, Page 129-30) S. No. Ingredients Botanical Quantity 1. Muqil Commiphora mukul 750 g 2. Post-e-Halela Kabli Terminalia chebula 170 g 3. Post-e-Balela Terminalia bellerica 170 g 4. Aamla Emblica officinalis 170 g page 4 / 6
5. Waj-e-Turki Acorus calamus 15 g 6. Baharangi Clerodendrum serratum 15 g 7. Atees Aconitum heterophyllum 15 g 8. Kutki Picrorhiza kurroa 15 g 9. Filifil Daraz Piper longum 15 g 10. Maror Phali Helictres isora 15 g 11. Baobarang Embelia ribes 15 g 12. Inderjao Talkh Holerrhena antidysenterica 15 g 13. Tukhm-e-Sambhalu Vitex negundo 15 g 14. Zeera Safaid Cuminum cyminum 15 g 15. Zeera Siyah Carum carvi 15 g 16. Tukhm-e-Karafs Apium graveolens 15 g 17. Hilteet Ferula foetida 15 g 18. Peepal Chab Piper chaba 15 g 19. Sheetraj Hindi Plumbago zeylancia 15 g 20. Filfil Moya Piper longum 15 g 21. Zanjabil Zingiber officianale 15 g 22. Qand Safaid --- 2.4 kg 23. Raughan Zard --- QS 24. Raughan-e-Sarson Brassica campestris QS Composition of Raughan-e-Malkangani (NFUM-I, Page 197) page 5 / 6
Powered by TCPDF (www.tcpdf.org) PDF of Trial S. No. Ingredients Botanical Quantity 1. Malkangani Celastrus paniculatus QS page 6 / 6