| CTRI Number |
CTRI/2025/12/098267 [Registered on: 01/12/2025] Trial Registered Prospectively |
| Last Modified On: |
25/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Treatment of pain in joints with Unani medicine itrifal muqil mullaiyan & roghan e babuna and hab suranjan & roghan suranjan. |
|
Scientific Title of Study
|
Comparative Clinical Validation study of Unani Pharmacopoeial formulation Itrifal-e-Muqil Mullaiyan & Roghan e Babuna Qawi vs Habb-e-Suranjan & Roghan e Suranjan in Waja ul Mafasil (Rheumatoid Arthritis) |
| Trial Acronym |
NILL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| WF/RA/IMM/RBQ/HS/RS/CLNVAL/CCRUM/23-24 , Version No-01 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr N Zaheer Ahmed |
| 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
South West
DELHI
110058
India |
| Phone |
01128525715 |
| Fax |
|
| Email |
drnzaheer@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ghazala Javed |
| Designation |
Assistant Director (Unani) |
| Affiliation |
Central Council for Research in Unani Medicine (CCRUM) |
| Address |
Room No. 506, Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri South West India
South West
DELHI
110058
India |
| Phone |
09811810454 |
| Fax |
|
| Email |
javed.ghazal@gmail.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 India
South West
DELHI
110058
India |
| Phone |
08800263300 |
| Fax |
|
| Email |
drpradeepkumar2001@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Infrastructural support:
1. Regional Research Institute of Unani Medicine (RRIUM),D-11/1, AbulFazal Enclave, Jamia Nagar, Okhla,New Delhi – 110 025.
2. Clinical Research Unit (CRU), Dr. Abdul Haq Unani Medical College, 40/23,Park Road,Kurnool-518 001
3. Clinical Research Unit (CRU), Department of Pharmacology Gandhi Medical College Bhopal – 462001 |
| Monetary Support : Central Council for Research in Unani Medicine (CCRUM),Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri, New Delhi-110058 |
|
|
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 Abdullah |
Clinical Research Unit, bhopal |
Research OPD room Waja ul Mafasil (Rheumatoid Arthritis),Department of Pharmacology, Gandhi Medical College
Bhopal – 462001 (M.P.)
Bhopal
MADHYA PRADESH |
97567 64198
drabdullha786@gmail.com |
| DrManchala Ashok |
Clinical Research Unit, kurnool |
Research OPD room Waja ul Mafasil (Rheumatoid Arthritis),Dr. Abdul Haq Unani Medical College, 40/23,Park Road,Kurnool-518001 (Andhra Pradesh)
Kurnool
ANDHRA PRADESH |
7013307287
dr.ashok.bums@gmail.com |
| Dr Hina Rehman |
Regional Research Institute of Unani Medicine |
Research OPD room Waja ul Mafasil (Rheumatoid Arthritis), D-11/1, AbulFazal Enclave, Jamia Nagar, Okhla, New Delhi – 110025
South
DELHI |
8297173005
Hinarehman06@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Clinical Research Unit, kurnool |
Submittted/Under Review |
| Institutional Ethical Committee, Bhopal |
Approved |
| Regional Research Institute of Unani Medicine, Delhi |
Submittted/Under Review |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M057||Rheumatoid arthritis with rheumatoid factor without organ or systems involvement, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Habb-e-Suranjan & Roghan e Suranjan |
1- Two tab (500 mg each) twice daily after meal.
2- Ointment apply locally on affected area twice a day |
| Intervention |
Itrifal Muqil Mulayyan & Roghan e Babuna Qawi |
1- Itrifal 5 gm twice daily after meal.
2- Ointment apply locally on affected area twice a day |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients fulfilling the 2010 ACR-EULAR Rheumatoid Arthritis Classification Criteria |
|
| ExclusionCriteria |
| Details |
1.Severe cases of RA (Stage III & IV) & diagnosed cases of ankylosing spondylosis/ Gout.
2.Cases with systemic manifestation of Rheumatoid arthritis.
3. Abnormality in any investigation done at baseline (SGOT, SGPT and ALP, Sr Creatinine, B. Urea would be considered abnormal if raised more than 2.5 times the normal value), also Patients with GFR less than 60 will be exclude from the study.
4. Patient with High grade fever.
5. Disorders requiring long term treatment.
6. Patient is on treatment for any illness related to Endocrine & metabolic disorders.
7. Pregnancy and lactation.
8. Drug addicts (Alcohol, drugs) |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The safety and efficacy of Unani Pharmacopeial formulation Itrifal-e-Muqil Mullaiyan & Roghan e Babuna Qawi in comparison with Habb-e-Suranjan & Roghan e Suranjan in Waja ul Mafasil (Rheumatoid Arthritis) will be carried out on the basis of DAS28 Form |
At baseline and every two weeks during the treatment period. (i.e., 0, 2nd, 4th, 6th.8th, 10th and 12th weeks).
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Haematological and biochemical investigations for safety assessment i.e., Hemogram, LFT,KFT, Urine Examination: Routine & Microscopic. |
At baseline and at the end of treatment. i.e., 0 and 12th week |
|
|
Target Sample Size
|
Total Sample Size="210"
Sample Size from India="210"
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)
|
10/12/2025 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Rheumatoid arthritis (RA) is a long-lasting
inflammatory condition of undetermined causative factors with the hallmark of
symmetric joint involvement. It is an autoimmune disorder in which the body’s
immune system attacks its own tissue, including joints. Due to the synovial
membrane being the primary target of RA, the synovium becomes inflamed and
proliferates, articular cartilage is lost, and the bone is eroded. Waja
ál-mafasil, an Arabic term made up of the terms "waja" for pain and
"mafasil" for joint, is used to explain rheumatoid arthritis in Unani
medicine. Waja ál-Mafasil is also referred to as "Hudar". The aim of
this trial is assess the safety and efficacy of Unani pharmacopoeial
formulation Itrifal-e-Muqil Mullaiyan & Roghan e Babuna Qawi vs
Habb-e-Suranjan & Roghan e Suranjan in patients of Waja-ul mafasil
(Rheumatoid Arthritis). This study is designed as a Multi
centric, Randomized, Parallel Group, Active Controlled 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 baseline and every two weeks during the treatment period. (i.e., 0, 2nd, 4th,
6th, 8th, 10th and 12th weeks).
The subjective and objective clinical observations will be recorded in the
follow-up sheet. 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 (i.e., 0 and
12th weeks).
Itrifal-e-Muqil-Mullaiyan | S. No | Ingredients | Botanical Names | Quantity | | 1. | Muqil | Commiphora mukul (Hook ex stocks) Engl. | 350gm | | 2. | Turbud Safaid | Operculina turpethum L Silva Manso. | 120gm | | 3. | Post-e-Halela Zard | Terminalia chebula Retz. | 90gm | | 4. | Post-Halela Kabli | Terminalia chebula Retz. | 90gm | | 5. | Post-e-Balela | Terminalia bellerica Roxb | 90gm | | 6. | Halela Siyah | Terminalia Chebula Retz | 90gm | | 7. | Aamla | Emblica officinalis Gaertn. | 90gm | | 8. | Mastagi | Pistacia lentiscus Linn | 50gm | | 9. | Raughan-e-Badam Shireen Or Raughan Zard | Prunus Amygdalus Dulcis | 150gm | | 10. | Asal or Qand Safaid | Honey | 3.5kg | | 11. | Aab-e-Gandana | Allium ascalonium L. | Q.S. |
Roghan e Babuna Qawi | S. No | Ingredients | Botanical Names | Quantity | | 1. | Sumbul-ut-Teeb | Nardostachys jatamansi D.Don. DC. | 12 g | | 2. | Bisbasa | Myristica fragrans Houtt. | 12 g | | 3. | Heel khurd | Elettaria cardamomum Maton | 12 g | | 4. | Hamama | Amomum racemosum L. | 12 g | | 5. | Tukhm-e-Katan | Linum usitatissimum L. | 12 g | | 6. | Ikleel-ul-Malik | Trigonella uncata Boiss. & Noe Lassen | 12 g | | 7. | Babuna | Matricaria chamomilla L. | 48 g | | 8. | Aab | Water | 12 times of all the ingredients | | 9. | Roghan-e-Kunjad | Sesamum indicum L. | Equal to all ingredients |
Comparator group Habb –e-Suranjan | S. No | Ingredients | Botanical Names | Quantity | | 1. | Suranjan | Colchicum luteum Baker. | 1 part | | 2. | Post e Halela Zard | Terminalia chebula Retz | 1 part | | 3. | Shahm e Hanzal | Citrullus colocynthis (L.) Schrad | 1 part | | 4. | Muqil | Commiphora mukul (Hook ex Stocks) Engl. | 1 part | | 5. | Trurbud | Operculina turpethum (L) Silva Manso. | 1 part | Roghan e suranjan | S. No | Ingredients | Botanical Names | Quantity | | 1. | Suranjan | Colchicum luteum Baker. | 50 g | | 2. | Aab e karafs | Apium graveolens L. | 50 g | | 3. | Chiraita | Swertia chirata Buch. Ham exWall | 50 g | | 4. | Roghan e zaitoon | Olea europaea L. | 150 g | |