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CTRI Number  CTRI/2022/01/039486 [Registered on: 17/01/2022] Trial Registered Prospectively
Last Modified On: 14/01/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Unani 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To Study the effect of Unani Compound Formulation in patients with Waja‘al-Mafasil (Rheumatoid Arthritis) 
Scientific Title of Study   Clinical Study of Waja‘al-Mafasil (Rheumatoid Arthritis) with Therapeutic Efficacy Evaluation of Unani Compound Formulation in its Management  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Atiba Jan 
Designation  PG Scholar 
Affiliation  Regional Research Institute of Unani Medicine (RRIUM) 
Address  Department of Moalajat RRIUM Naseem Bagh Campus of University of Kashmir Srinagar Jammu and Kashmir India

Srinagar
JAMMU & KASHMIR
190006
India 
Phone  7889431573  
Fax    
Email  aatibajan124@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shameem Ahmad Rather 
Designation  Reader 
Affiliation  Regional Research Institute of Unani Medicine (RRIUM) 
Address  Department of Moalajat RRIUM Naseem Bagh Campus of University of Kashmir Srinagar Jammu and Kashmir India

Srinagar
JAMMU & KASHMIR
190006
India 
Phone  7889584083  
Fax    
Email  shameem.rather.sr@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Towseef Amin Rafeeqi  
Designation  Research Officer (Biochemistry) 
Affiliation  Regional Research Institute of Unani Medicine(RRIUM) 
Address  Department of Moalajat RRIUM Naseem Bagh Campus of University of Kashmir Srinagar Jammu and Kashmir India

Srinagar
JAMMU & KASHMIR
190006
India 
Phone  9149998380  
Fax    
Email  towseef@gmail.com  
 
Source of Monetary or Material Support  
Central Council for Research in Unani Medicine New Delhi 
 
Primary Sponsor  
Name  Central Council for Research in Unani Medicine New Delhi 
Address  Regional Research Institute of Unani Medicine (RRIUM)University of Kashmir Srinagar CCRUM New Delhi 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Atiba Jan  Regional Research Institute of Unani Medicine (RRIUM)  Maolajat OPD-1,Ground Floor,Department of Moalajat,RRIUM,Naseem Bagh Campus University of Kashmir Hazratbal.
Srinagar
JAMMU & KASHMIR 
7889431573

aatibajan124@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, RRIUM,Srinagar  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M05||Rheumatoid arthritis with rheumatoid factor, (2) ICD-10 Condition: M057||Rheumatoid arthritis with rheumatoid factor without organ or systems involvement,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Sulfasalazine  Sulfasalazine 500mg Tablet twice a day will be given orally, 12 hourly after the meals for 45 days.  
Intervention  Unani Compound Formulation   Unani Compound formulation contains Suranjan Talkh (Colchicum luteum Baker-Dried Corm-1 part), Zanjabeel (Zingiber officinale Rosc. Dried Rhizome- 1 part) and Aelva ( Aloe barbadensis Mill. Dried Exudate- 2 part). All these ingredients will be ground together and sieved through 100 No. mesh to make a fine powder (Safoof). 7g of this Safoof will be given orally once a day after the meals in the evening with Luke warm water for 45 days. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Patients irrespective of gender will be selected for the study.
2. Patients in the age group of 18 to 65 years fulfilling the criteria of the New American College of Rheumatology-European League Against Rheumatism 2010 for the diagnosis of rheumatoid arthritis.
3. Patients, who are ready to sign the informed consent, follow the protocol and willing to participate in the clinical study voluntarily.
4. Patients with features of preclinical rheumatoid arthritis, established rheumatoid arthritis and presence of active disease will be included in the study.

 
 
ExclusionCriteria 
Details  1. Patients below 18 years and above 65 years of age.
2. Patients who fail to follow up.
3. Patients who fail to give written consent.
4. Women who are pregnant, planning pregnancy, or breast feeding.
5. Patients having other types of arthritis.
6. Patients with the history of any systemic illness like uncontrolled diabetes, malignant hypertension, cardiovascular diseases, severe blood disorders and impaired renal function or patient with any other severe chronic or acute disease interfering with attendance for therapy.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Pain intensity, Swollen joint count, Morning stiffness and Fatigue.The Data for these subjective parameters will be recorded on 0,7th,15th,30th and 45th day.

 
45 Days 
 
Secondary Outcome  
Outcome  TimePoints 
DAS 28 (Disease Activity Score), DAS 28-CRP, Erythrocyte Sedimentation Rate (ESR), Quantitative C -reactive protein (CRP), Quantitative Rheumatoid factor (RF) , Quantitative Anti-citrullinated protein antibody (ACPA/Anti-CCP),and Interleukin 6(IL-6).The data for these objective parameters including serum biomarkers will be recorded on 0th and 46th day of the study.The ECG, Haematological and Biochemical assessment will be done before and after the study in view of safety evaluation.
The Data for remaining objective parameters i.e.Tender joint count and HAQ disability index score will be recorded on 0,7th,15th,30th and 45th day.

 
45 days 
 
Target Sample Size   Total Sample Size="42"
Sample Size from India="42" 
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)   25/01/2022 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Rheumatoid arthritis is a chronic inflammatory autoimmune disease of unknown etiology characterized by symmetric polyarthritis. The hallmark of persistently active rheumatoid arthritis is that it often results in articular cartilage damage, bone destruction, and functional disability. The prevalence of this disease is approximately 0.8–1.0% in Europe and the Indian subcontinent, with a female-to-male ratio of 3:1. In India, the prevalence of this disease is 0.5% to 0.75%.It is said that one in 12 women and one in 20 men will develop rheumatoid arthritis during their lifetime. Etiology of rheumatoid arthritis remains elusive although it appears that genetics, immunological derangement, infections, environmental and hormonal factors (In females) are all involved in the complex . This disease affects people between 25 and 55 years of age, after which it plateaus until the age of 75 and then decreases. The typical presentation of rheumatoid arthritis is pain, inflammation of joints, tendons and bursae, joint swelling, tenderness, and early morning stiffness lasting more than one hour that eases with physical activity, associated with constitutional symptoms of fatigue, malaise, loss of appetite and weight loss. It is a systemic disorder, thus may also lead to a variety of extra-articular manifestations .

In the Unani system of medicine it is not mentioned under the heading of Rheumatoid Arthritis but the disease has been vividly described by various Unani physicians under a generalized term Waja‘al-Mafasil. The causes of rheumatoid arthritis described in modern medicine are different from the causes explained in the Unani system of medicine. The conventional medications used for the treatment of this disease may be divided into broad categories: non steroidal anti-inflammatory drugs; gluco-corticoids, conventional disease modifying antirheumatic drugs including Hydroxychloroquine, Sulfasalazine, and Methotrexate; and biologic disease modifying antirheumatic drugs. However, they are frequently associated with a fair degree of moderate to severe side effects including gastritis, peptic ulcer disease, renal function impairment in case of non steroidal anti-inflammatory drugs and corticosteroids, nausea, diarrhea, headache, rashes, cardiotoxicity, blood dyscrasia, irreversible retinal damage, hepatotoxicity, neurological deficit, granulocytopenia, hemolytic anemia, myelo-suppression in case of disease modifying antirheumatic drugs.Thus there is a gross requirement for alternative treatment. The Unani compound formulation  containing Suranjan Talkh (Colchicum luteum Baker), Zanjabeel (Zingiber officinale Rosc.)and Aelva (Aloe barbadensis Mill.) is mentioned to be used in Waja‘al-Mafāṣil in the Bayaz-e-Khass of Hakeem Sharief Khan. The principle of treatment aims at restoring the normal temperament and correcting the imbalance in the Khilá¹­ (humour) through Imāla (Diversion of morbid material) and Istifrāgh (Evacuation of morbid material). Significant anti-arthritic activity of this Unani pharmacopoeial formulation has been studied in albino rats. Thus in order to provide safe and more effective treatment for rheumatoid arthiritis the present study entitled "Clinical Study of Waja‘al-Mafāṣil (Rheumatoid Arthritis) with Therapeutic Efficacy Evaluation of Unani Compound Formulation in its Management” is designed.

 
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