| CTRI Number |
CTRI/2015/02/005561 [Registered on: 23/02/2015] 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 study the Anti Inflammatory and Anti Arthiritic effect of Majun Jograj Gugal and Raughan-e-Malkangani on Waja‘al-Mafasil (Rheumatoid Arthritis) |
|
Scientific Title of Study
|
Immunological study on Unani Pharmacopoeial drugs Majun Jograj Gugal and Raughan-e-Malkangani to validate their Anti Inflammatory and Anti Arthiritic property in the cases of 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 |
8800263300 |
| Fax |
|
| Email |
drpradeepkumar2001@gmail.com |
|
|
Source of Monetary or Material Support
|
| Infrastructural support 1.Regional Research Institute of Unani Medicine Patna 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 = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR TASLEEM AHMAD |
Regional Research Institute of Unani Medicine (RRIUM), Patna |
Guzri, Patna City
Patna
BIHAR |
09304109801
tasleem786@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| 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 |
This study will Scientifically validate, anti-inflammatory and anti-arthritic property of Majoon Jograj Goggul and Roghan Malkangani by using some immunological markers of inflammation and arthritis
|
12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
This study will help us to know the status of these Immunological markers of arthritis such as IL-1β, IL-6, IL-11, TNF-α IL-17, high sensitive C-reactive protein and rheumatoid factor in cases in cases of Waja‘ al-Mafasil (Rheumatoid Arthritis)
and its modulation by unani pharmacopoeal formulations
|
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)
|
01/03/2015 |
| 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
|
The
present proposal is open labelled and will be undertaken to scientifically
validate the efficacy claims of Unani Pharmacopoeial drugs Majoon Jograj Goggul and
Roghan Malkangani to investigate immunological tools such as IL-1b,
IL-6, TNF-a, IL-11, IL-17, Highsensitive
C-reactive proteins, Rheumatoid Arthritis factor, before and after treatment of
these Unani Pharmacopoeial drugs in the patients of waja-al-Mafasil(Rheumatoid
arthritis) registered in Regional research institute of Unani medicine Patna.
These immunological studies are proposed to strengthen the efficacy claim of
these Unani Pharmacopoeial drugs.
|
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
|
|