| CTRI Number |
CTRI/2020/07/026543 [Registered on: 14/07/2020] Trial Registered Prospectively |
| Last Modified On: |
09/07/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Treatment of Arthritis (pain in joints) by Unani medicine Habb-e-Irq un Nisa |
|
Scientific Title of Study
|
Clinical Validation of Unani Pharmacopoeial Formulation Habb-e-Irq un Nisa in Waja‘al-MafÄsil (Rheumatoid Arthritis) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| WM/RA/HIN/CLNVAL/CCRUM/ 18-19, Version 1, 11-04-19 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof Asim Ali Khan |
| Designation |
Director General |
| Affiliation |
Central Council for Research in Unani Medicine (CCRUM) |
| Address |
Room No 523, Vth Floor
Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri
South West
DELHI
110058
India |
| Phone |
01128525715 |
| Fax |
|
| Email |
unanimedicine@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Naheed Parveen |
| Designation |
Assistant Director |
| Affiliation |
Central Council for Research in Unani Medicine (CCRUM) |
| Address |
Room No. 507, 5th Floor,
Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri
South West
DELHI
110058
India |
| Phone |
9213511298 |
| Fax |
|
| Email |
ccrum507@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pradeep Kumar |
| Designation |
Research Officer (Pathology) S-IV |
| Affiliation |
Central Council for Research in Unani Medicine (CCRUM) |
| Address |
Room no. 516, 5th Floor, Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri
South West
DELHI
110058
India |
| Phone |
8800263300 |
| Fax |
|
| Email |
drpradeepkumar2001@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Infrastructural support : 1 Central Research Institute of Unani Medicine (CRIUM), Lucknow 2. Regional Research Institute of Unani Medicine (RRIUM), Patna 3. Regional Research Centre (RRC), Allahabad 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 Mohd Tariq |
Central Research Institute of Unani Medicine (CRIUM) |
Research OPD Room Waja‘al-MafÄsil (Rheumatoid Arthritis)
Basaha, Kursi Road
Lucknow
UTTAR PRADESH |
8299875352
drtariqnium@gmail.com |
| Dr Mohd Ehsan Ansari |
Regional Research Centre (RRC) |
Research OPD Room Waja‘al-MafÄsil (Rheumatoid Arthritis)
B-501/4, G T B Nagar (Opposite Dulhan Palace)
Allahabad
UTTAR PRADESH |
8887801120
dr.mehsan.ansari786@gmail.com |
| Dr Mumtaz Ahmad |
Regional Research Institute of Unani Medicine (RRIUM) |
Research OPD Room Waja‘al-MafÄsil (Rheumatoid Arthritis)
Guzri, Patna City
Patna
BIHAR |
9140843920
mumtazahmad1966@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Central Research Institute of Unani Medicine (CRIUM), Lucknow |
Submittted/Under Review |
| Regional Research Centre (RRC), Allahabad |
Submittted/Under Review |
| Regional Research Institute of Unani Medicine (RRIUM), Patna |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M059||Rheumatoid arthritis with rheumatoid factor, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Habb-e-Irq un Nisa |
2 Tablets Orally Daily To be taken with water after meals for 12 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-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) |
|
| 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. Known case 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. |
|
|
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 of Waja‘al-MafÄsil (Rheumatoid Arthritis) |
12 Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Haematological and biochemical assessment for safety assessment |
Investigations will be done at baseline and end of treatment. After 12 weeks of treatment. |
|
|
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 3 |
|
Date of First Enrollment (India)
|
18/07/2020 |
| 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
|
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‘al-MafÄsil (Rheumatoid Arthritis). After screening, Patients will be enrolled if they satisfy inclusion and exclusion criteria. The patients will be treated with Unani pharmacopoeial formulation Hab-e-Irq un Nisa two tablets orally daily with water after meals for 12 weeks. The patients will be assessed at every 2 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. Composition of Hab-e-Irq un Nisa | S.No. | Ingredients | Botanical Name | Quantity | | 1. | Sibr | Aloe Barbadensis | 3.5 g | | 2. | Post Halela Zard | Terminalia Chebula | 3.5 g | | 3. | Suranjan Shireen | Colchicum Luteum | 3.5 g | |