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
|
|
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
|
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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.
|
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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-MafÄá¹£il 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 ImÄla (Diversion of morbid material) and IstifrÄgh (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-MafÄá¹£il (Rheumatoid Arthritis) with Therapeutic Efficacy Evaluation of Unani Compound Formulation in its Management†is designed. |