| CTRI Number |
CTRI/2018/08/015451 [Registered on: 23/08/2018] Trial Registered Prospectively |
| Last Modified On: |
07/12/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Unani medicine Habb-e-Suranjan in Waja ul Mafasil (Rheumatoid Arthritis) |
|
Scientific Title of Study
|
Clinical Validation of Unani Pharmacopoeal formulation Habb-e-Suranjan in Waja ul Mafasil (Rheumatoid Arthritis) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| WM/ RA/ HS/ CLNVAL/CCRUM 16-17 version 1 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Naheed Parveen |
| Designation |
Assistant Director |
| Affiliation |
Central Council for Research in Unani Medicine (CCRUM) |
| Address |
Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri
South West
DELHI
110058
India |
| Phone |
|
| Fax |
|
| Email |
ccrum507@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Naheed Parveen |
| Designation |
Assistant Director (Unani) |
| Affiliation |
Central Council for Research in Unani Medicine (CCRUM) |
| Address |
Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri
South West
DELHI
110058
India |
| Phone |
|
| Fax |
|
| Email |
ccrum507@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pradeep Kumar |
| Designation |
Research Officer Scientist IV (Path) |
| Affiliation |
Central Council for Research in Unani Medicine (CCRUM) |
| Address |
Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri
South West
DELHI
110058
India |
| Phone |
|
| Fax |
|
| Email |
drpradeepkumar2001@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
Source of Monetary or Material Support
Infrastructural support : 1 Regional Research Institute of Unani Medicine (RRIUM), Srinagar 2. Regional Research Institute of Unani Medicine(RRIUM), Bhadrak 3. Regional Research Centre, Silchar Monetary Support : Central Council for Research in Unani Medicine (CCRUM), New Delhi |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Unani Medicine CCRUM New Delhi |
| Address |
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
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Akhtar Hussain Jamali |
Regional Research Centre |
Research OPD Room Waja ul Mafasil (Rheumatoid Arthritis)
S M Dev Hospital, Silchar
Cachar
ASSAM |
8811907160
crukxj522@gamail.com |
| Dr Huma |
Regional Research Institute of Unani Medicine |
Research OPD Room Waja ul Mafasil (Rheumatoid Arthritis) Naseem Bagh Campus, University of Kashmir
Srinagar
JAMMU & KASHMIR
Srinagar
JAMMU & KASHMIR |
01942414604
rrium.srinagar@gmail.com |
| Dr Mohammad Naseem |
REGIONAL RESEARCH INSTITUTE OF UNANI MEDICINE |
Research OPD Room Waja ul Mafasil (Rheumatoid Arthritis) Chandbali Bye Pass Road
Bhadrak
ORISSA
Bhadrak
ORISSA |
06784251289
naseemrrium@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Regional Research Centre, Silchar |
Approved |
| Regional Research Institute of Unani Medicine, Bhadrak |
Approved |
| Regional Research Institute of Unani Medicine, Srinagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
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 |
Habb-e-Suranjan |
Habb-e-Suranjan Pill (360 mg each) One Twice daily Oral To be taken with water after meals for 6 weeks
|
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of either sex in the age group 18-65 years.
2. Patients having Waja‘al-MafÄsil (Rheumatoid arthritis) as defined by the following ACR-EULAR criteria (Annexure IV):
(i) Definite clinical synovitis (pain, swelling, tenderness) in at least 1 joint
(ii) Absence of an alternative diagnosis for the observed synovitis (arthritis)
(iii) 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)
|
|
| ExclusionCriteria |
| Details |
1. Rheumatoid arthritis with extra-articular manifestations, joint deformities, and advanced radiological lesions (e.g. joint subluxation and collapse).
2. Obese subjects (BMI ≥30)
3. 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.
4. History or clinical evidence of any serious systemic illness, DM, TB, HIV infection etc
5. 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.
6. Screening laboratory test values, including S. Creatinine, BUN, S. Bilirubin outside the reference range, and SGOT, SGPT raised >2.5 times the ULN.
7. History of hypersensitivity to study drug or any of its ingredients.
8. 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 sign and symptoms of Waja ul Mafasil (Rheumatoid Arthritis) |
Six Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Hematological and biochemical assessments for safety |
6 weeks |
|
|
Target Sample Size
|
Total Sample Size="240"
Sample Size from India="240"
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)
|
24/08/2018 |
| 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) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is 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 at every two weeks. 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 on completion of the protocol therapy.
|
S. No.
|
Ingredients
|
Botanical /
English Name
|
Quantity
|
|
1.
|
Suranjan Shirin
|
Colchicum autumnale Linn.
|
1 Part
|
|
2.
|
Post-i Halela Zard
|
Terminalia citrina
|
1 Part
|
|
3.
|
Shahm-i Hanzal
|
Citrullus
colocynthis (Linn.)
Schrad.
|
1 Part
|
|
4.
|
Muqil
|
C.
mukul (Hook.
ex Stocks) Engl.
|
1 Part
|
|
5.
|
Turbud
|
Operculina
turpethum (Linn.)
S.
|
1 Part
|
|