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CTRI Number  CTRI/2013/12/004199 [Registered on: 09/12/2013] Trial Registered Retrospectively
Last Modified On: 03/12/2018
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Unani 
Study Design  Single Arm Study 
Public Title of Study   Treatment of Rheumatoid Arthiritis with Unani formulations  
Scientific Title of Study   Validation of a Unani Pharmacopoeial formulation in Waja ul Mafasil (Rheumatoid Arthritis) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Abdul Hannan  
Designation  JOINT DIRECTOR 
Affiliation  Central Council for Research in Unani Medicine (CCRUM) 
Address  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
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
New Delhi
DELHI
110058.
India 
Phone  011-28521981  
Fax  011-28522965  
Email  ccrum605@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Abdul Hannan  
Designation  JOINT DIRECTOR 
Affiliation  Central Council for Research in Unani Medicine (CCRUM) 
Address  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
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
New Delhi
DELHI
110058.
India 
Phone  011-28521981  
Fax  011-28522965  
Email  ccrum605@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Abdul Hannan  
Designation  JOINT DIRECTOR 
Affiliation  Central Council for Research in Unani Medicine (CCRUM) 
Address  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
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
New Delhi
DELHI
110058.
India 
Phone  011-28521981  
Fax  011-28522965  
Email  ccrum605@gmail.com  
 
Source of Monetary or Material Support  
Infrastructural support : 1.Regional Research Institute of Unani Medicine (RRIUM), Patna 2. Regional Research Institute of Unani Medicine(RRIUM), Chennai 3. Central Research Institute of Unani Medicine(CRIUM), Lucknow Monetary Support : Central Council for Research in Unani Medicine (CCRUM), New Delhi  
 
Primary Sponsor  
Name  Monetary Support Central Council for Research in Unani Medicine CCRUM New Delhi  
Address  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-110058.  
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR A B ALVI  Central Research Institute of Unani Medicine (CRIUM),   C-39,Maakaila Bhawan Sector-C, Sitapur Road yojana, LalaLajpat Rai Ward, Lucknow-226021 U.P.
Lucknow
UTTAR PRADESH 		 05222361720

abalvi@rediffmail.com 
DR K KABIRUDDIN AHMAD  Regional Research Institute of Unani Medicine (RRIUM), Chennai  1-west Meda Church Street, Royapuram,Chennai-600013 T.N.
Chennai
TAMIL NADU 		 04425955519

rriumchennai@gmail.com 
DR ISHTIYAQ ALAM  Regional Research Institute of Unani Medicine, Patna  Manas Path opp. Patna City Hospital Patna-800008 Bihar
Patna
BIHAR 		 0612-2631106

mailme_dralam@rediffmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
CRIUM), INSTITUTIONAL ETHICS COMMITTEE, LUCKNOW, DR A B ALVI, PRINCIPAL INVESTIGATOR  Approved 
RRIUM INSTITUTIONAL ETHICS COMMITTEE, PATNA, DR ISHTIYAQ ALAM, PRINCIPAL INVESTIGATOR  Approved 
RRIUM), INSTITUTIONAL ETHICS COMMITTEE, cHENNAI, DR K KABIRUDDIN AHMAD, PRINCIPAL INVESTIGATOR  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M057||Rheumatoid arthritis with rheumatoid factor without organ or systems involvement, Waja ul Mafasil (Rheumatoid Arthritis),  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  1. Majoon-e-Suranjan 2.Safoof suranjan 3.Raughan e Suranjan  1.Majoon-e-Suranjan 7 gm orally two times daily with water. 2.Safoof suranjan 6gm two times daily with water. 3. Raughan e Suranjan, Oil , locally,once daily All the three drugs will be given for a period of 12 weeks  
Comparator Agent  nil  nil 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  • Patients of either sex in the age group of 20-60
• Patients fulfilling the ACR criteria for rheumatoid arthritis i.e the 2010 American College of Rheumatology/European League Against Rheumatism classification Criteria for rheumatoid arthritis

 
 
ExclusionCriteria 
Details  • Patients having Gout, or complicated rheumatoid arthritis associated with deformity.
• Abnormality in any investigation done at baseline (SGOT, SGPT and ALP,Sr Creatinine, B.Urea would be considered abnormal if raised 2 ½ times the normal value )
• Overweight subjects – BMI 35
• Disorders requiring long term treatment
• Drug addicts ( Alcohol, drugs )
• Pregnant and lactating women  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Improvement in signs and symptoms   12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Hematological and biochemical assessments for safety   12 weeks 
 
Target Sample Size   Total Sample Size="300"
Sample Size from India="300" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   08/09/2012 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   This study is designed as a multicentric open trial in patients with Waja ul Mafasil (Rheumatoid Arthritis). After screening, Patients will be enrolled if they satisfy inclusion and exclusion criteria. The patients will be assessed clinically on each fortnightly follow up. This includes subjective assessment of general well being and physical examination . The total duration of treatment will be 12 weeks. . Laboratory parameters for safety assessment will be conducted at baseline and end of study.  
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