| CTRI Number |
CTRI/2015/03/005638 [Registered on: 16/03/2015] Trial Registered Prospectively |
| Last Modified On: |
04/12/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To evaluate the Safety and efficacy of two Unani formulations Majun Jograj Gugal and Raughan-e-Malkangani in Waja‘al-Mafasil (Rheumatoid Arthritis) |
|
Scientific Title of Study
|
Clinical Validation of Unani Pharmacopoeial formulations – Majun Jograj Gugal and Raughan-e-Malkangani in Waja‘al-Mafasil (Rheumatoid Arthritis) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| WM/RA/MJGRM CLNVAL/CCRUM 14-15 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
PROF RAIS UR RAHMAN |
| Designation |
DIRECTOR GENERAL |
| 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
West
DELHI
110058
India |
| Phone |
01128521981 |
| Fax |
|
| Email |
drrahman002@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR KHALID M SIDDIQUI |
| Designation |
DEPUTY DIRECTOR GENERAL |
| 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
West
DELHI
110058
India |
| Phone |
9810161758 |
| Fax |
|
| Email |
ccrum507@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR PRADEEP KUMAR |
| Designation |
RESEARCH OFFICER SCIENTIST III |
| 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
West
DELHI
110058
India |
| Phone |
01128521981 |
| Fax |
|
| Email |
drpradeepkumar2001@gmail.com |
|
|
Source of Monetary or Material Support
|
| Infrastructural support 1.Central Research Institute, Lucknow 2.Regional Research Institute of Unani Medicine Patna, 3.Clinical Research Unit, Kurnool Monetary Support : Central Council for Research in Unani Medicine, New Delhi |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Unani Medicine 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 A V ALVI |
Central Research Institute, Lucknow |
C-39, MAAKAILA SECTOR C, SITAPUR ROAD YOGNA, LALA LATPAT RAI WARD
Lucknow
UTTAR PRADESH |
09455282012
abalvi@rediffmail.com |
| DR MOHD TARIQ KHAN |
Clinical Research Unit |
CANTONMENT GENERAL HOSPITAL, BEGUM BRIDGE (SOTI GANJ)
Meerut
UTTAR PRADESH |
08266001184
doctormtk@gmail.com |
| DR WASIM AHMAD |
Regional Research Institute of Unani Medicine (RRIUM), Patna |
Guzri, Patna City
Patna
BIHAR |
09555904810
mwasimahmed95@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Central Research Institute, Lucknow |
Submittted/Under Review |
| Clinical Research Unit |
Submittted/Under Review |
| Regional Research Institute of Unani Medicine (RRIUM), Patna |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M059||Rheumatoid arthritis with rheumatoid factor, unspecified, Waja‘al-Mafasil (Rheumatoid Arthritis), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Majun Jograj Gugal and Raughan-e-Malkangani |
1.Majun Jograj Gugal: Dose five grams twice daily orally after meals for a period of 12 weeks
2.Raughan-e-Malkangani: Dose- Quantity sufficient local application on the affected joint (Lukewarm application on affected joint) for a period of 12 weeks |
| Comparator Agent |
nil |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
• Patients of either sex in the age group 18-65 years.
• 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 |
• Rheumatoid arthritis with extra-articular manifestations, joint deformities, and advanced radiological lesions (e.g. joint subluxation and collapse).
• Obese subjects (BMI ≥30)
• 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.
• History or clinical evidence 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.
• 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.
• Screening laboratory test values, including SGOT, SGPT, ALP, S. creatinine, B. urea, and uric acid outside the reference range (raised >3 times the ULN) that, in the opinion of the investigator, could pose an unacceptable risk to the participant.
• History of hypersensitivity to study drug or any of its ingredients.
• Pregnant and lactating women
• H/o Addiction (alcohol, drugs)
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in signs and symptoms of Waja‘al-Mafasil (Rheumatoid Arthritis) |
12 WEEKS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Haematological and biochemical assessments for safety
ï‚· Improvement in the feeling of well-being of the patient |
12 WEEKS |
|
|
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 2 |
|
Date of First Enrollment (India)
|
01/04/2015 |
| 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-Mafasil (Rheumatoid Arthritis). Patients will receive the study drug Majun Jograj Gugal as oral and Raughan-e-Malkangani as local application twice daily for a period 12 weeks. All the laboratory parameters will be recorded at baseline and at the end of the study.
|
S. No.
|
Ingredients
|
Botanical Name
|
Quantity
|
|
1.
|
Muqil
|
Commiphora
mukul
|
750 g
|
|
2.
|
Post-e-Halela Kabli
|
Terminalia
chebula
|
170 g
|
|
3.
|
Post-e-Balela
|
Terminalia
bellerica
|
170 g
|
|
4.
|
Aamla
|
Emblica
officinalis
|
170 g
|
|
5.
|
Waj-e-Turki
|
Acorus calamus
|
15 g
|
|
6.
|
Baharangi
|
Clerodendrum
serratum
|
15 g
|
|
7.
|
Atees
|
Aconitum
heterophyllum
|
15 g
|
|
8.
|
Kutki
|
Picrorhiza
kurroa
|
15 g
|
|
9.
|
Filifil Daraz
|
Piper longum
|
15 g
|
|
10.
|
Maror Phali
|
Helictres
isora
|
15 g
|
|
11.
|
Baobarang
|
Embelia ribes
|
15 g
|
|
12.
|
Inderjao Talkh
|
Holerrhena
antidysenterica
|
15 g
|
|
13.
|
Tukhm-e-Sambhalu
|
Vitex negundo
|
15 g
|
|
14.
|
Zeera Safaid
|
Cuminum
cyminum
|
15 g
|
|
15.
|
Zeera Siyah
|
Carum carvi
|
15 g
|
|
16.
|
Tukhm-e-Karafs
|
Apium
graveolens
|
15 g
|
|
17.
|
Hilteet
|
Ferula foetida
|
15 g
|
|
18.
|
Peepal Chab
|
Piper
chaba
|
15 g
|
|
19.
|
Sheetraj Hindi
|
Plumbago
zeylancia
|
15 g
|
|
20.
|
Filfil Moya
|
Piper longum
|
15 g
|
|
21.
|
Zanjabil
|
Zingiber officianale
|
15 g
|
|
22.
|
Qand Safaid
|
---
|
2.4 kg
|
|
23.
|
Raughan Zard
|
---
|
QS
|
|
24.
|
Raughan-e-Sarson
|
Brassica campestris
|
QS
|
|
S.
No.
|
Ingredients
|
Botanical
Name
|
Quantity
|
|
1.
|
Malkangani
|
Celastrus paniculatus
|
QS
|
|