| CTRI Number |
CTRI/2023/04/051555 [Registered on: 12/04/2023] Trial Registered Prospectively |
| Last Modified On: |
11/04/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Treatment of Pain in joints with Unani medicine Habb e Mafasil and Zamad e Muhallil |
|
Scientific Title of Study
|
Clinical validation of Unani Pharmacopoeial formulation Habb e Mafasil and Zamad e Muhallil in Waja ul Mafasil (Rheumatoid arthritis) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| WM/RA/HMZM/CLNVAL/CCRUM /21-22, version 01, 18/12/2022 |
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. 502, 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, 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, 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 Regional Research Institute of Unani Medicine (RRIUM), Kolkata 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 = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mohd Tariq |
Regional Research Institute of Unani Medicine (RRIUM) |
Chandbali By-pass Road, Near Rural Police Station
Bhadrak
ORISSA |
8984112448
drtariqbdk@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Regional Research Institute of Unani Medicine, Bhadrak |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M069||Rheumatoid arthritis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Habb-e-Mafasil |
2 pills (500mg each) thrice daily orally to be taken with water after meals for 12 weeks |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Zamad-e-Muhallil |
Powder QS twice daily locally to be applied lukewarm on affected area after mixing with water to make paste for 12 weeks |
|
|
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 Wajaul Mafasil (RA) as defined by the following ACR-EULAR criteria:
Definite clinical synovitis (pain, swelling,
tenderness) in at least 1 joint
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:
Number and site of involved joints (range 0-5)
Serological abnormalities (range 0-3)
Elevated acute-phase reactants (range 0-1)
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 |
| the efficacy of study drugs will be assessed on the basis of improvement in symptoms i.e. VAS (0-100 mm) for joint pain and DAS28 (0-10) for clinical disease activity. |
At every 2 weeks, i.e. at days 14, 28, 42, 56, 70 and on 84 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Haematological and biochemical assessment for safety assessment |
At baseline and after 12 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 3 |
|
Date of First Enrollment (India)
|
13/04/2023 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is designed as a single centric 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 for 12 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 Habb-e-Mafasil
|
S.
No.
|
Ingredients
|
Botanical
/ English Name
|
Quantity
|
|
1.
|
Suranjan Talkh
|
Colchicum luteum Baker.
|
10 g
|
|
2.
|
Sibr
|
Aloe vera Linn.
|
10 g
|
|
3.
|
Turbud Safaid
|
Operculina
turpethum Linn.
|
10 g
|
|
4.
|
Sana
|
Cassia
angustifolia Vahl.
|
10 g
|
|
5.
|
Afsanteen
|
Artemisia
absinthium Linn.
|
10 g
|
|
6.
|
Namak Sanbhar
|
Sanbhar Salt
|
10 g
|
|
7.
|
Shahm-e-Hanzal
|
Citrullus
colocynthis Linn.
|
10 g
|
|
8.
|
Ajmod
|
Apium
graveolens Linn.
|
10 g
|
|
9.
|
Aab-e-Garm
|
Warm Water
|
Q.S.
|
Composition of Zamad-e-Muhallil
|
S.
No.
|
Ingredients
|
Botanical
/ English Name
|
Quantity
|
|
1.
|
Ikleel-ul-Malik
|
Astragalus hamosus Linn.
|
1 kg.
|
|
2.
|
Babuna
|
Matricaria Chamomilla Linn.
|
1 kg
|
|
3.
|
Asgand Nagori
|
Withania
somnifera Linn.
|
1 kg
|
|
4.
|
Mako
|
Solanum nigrum
Linn.
|
1 kg
|
|
5.
|
Tukhm Khatmi
|
Althaea
officinalis Linn.
|
1 kg
|
|
6.
|
Rewand Chini
|
Rheum
emodi Linn.
|
1 kg
|
|
7.
|
Muqil
|
Commiphora
wightii Arn.
|
250 g
|
|