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Clinical Trial Details (PDF Generation Date :- Tue, 02 Apr 2019 12:10:40 GMT)

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 Trial
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 Immunological study on Unani Pharmacopoeial drugs Majun Jograj Gugal and
Study Raughan-e-Malkangani to validate their Anti Inflammatory and Anti Arthiritic property in the cases of
Waja‘al-Mafasil (Rheumatoid Arthritis)
Secondary IDs if Any Secondary ID Identifier
WM/RA/MJGRM CLNVAL/CCRUM 14-15 Protocol Number
Details of Principal Details of Principal Investigator
Investigator or overall
Name PROF RAIS UR RAHMAN
Trial Coordinator
(multi-center study) 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 Contact Details Contact Person (Scientific Query)
Person (Scientific
Name DR KHALID M SIDDIQUI
Query)
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 Contact Details Contact Person (Public Query)
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

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DELHI
110058
India
Phone 8800263300
Fax
Email drpradeepkumar2001@gmail.com
Source of Monetary or Source of Monetary or Material Support
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 Primary Sponsor Details
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 Name Address
Sponsor
NIL NA
Countries of List of Countries
Recruitment
India
Sites of Study Name of Principal Name of Site Site Address Phone/Fax/Email
Investigator
DR TASLEEM AHMAD Regional Research Guzri, Patna City 09304109801
Institute of Unani Patna
Medicine (RRIUM), BIHAR tasleem786@rediffmail.
Patna com
Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics
Committee Committee?
Regional Research Approved 04/12/2014 No
Institute of Unani
Medicine (RRIUM),
Patna
Regulatory Clearance Status Date
Status from DCGI
Not Applicable No Date Specified
Health Condition / Health Type Condition
Problems Studied
Patients Rheumatoid arthritis with rheumatoid factor,
unspecified
Patients Waja‘al-Mafasil (Rheumatoid Arthritis)
Intervention / Type Name Details
Comparator Agent
Intervention Majun Jograj Gugal and 1.Majun Jograj Gugal: Dose five
Raughan-e-Malkangani 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 Inclusion Criteria
Age From 18.00 Year(s)

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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)
Exclusion Criteria Exclusion Criteria
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 Not Applicable
Random Sequence
Method of
Concealment
Blinding/Masking
Primary Outcome Outcome Timepoints
This study will Scientifically validate, 12 weeks
anti-inflammatory and anti-arthritic property of
Majoon Jograj Goggul and Roghan Malkangani
by using some immunological markers of
inflammation and arthritis

Secondary Outcome Outcome Timepoints

This study will help us to know the status of 12 weeks
these Immunological markers of arthritis such as
IL-1?, IL-6, IL-11, TNF-? IL-17, high sensitive

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C-reactive protein and rheumatoid factor in

cases in cases of Waja‘ al-Mafasil (Rheumatoid
Arthritis)
and its modulation by unani pharmacopoeal
formulations

Target Sample Size Total Sample Size=300

Sample Size from India=300
Phase of Trial Phase 2
Date of First 01/03/2015
Enrollment (India)
Date of First No Date Specified
Enrollment (Global)
Estimated Duration of Years=2
Trial Months=0
Days=0
Recruitment Status of Not Applicable
Trial (Global)
Recruitment Status of Not Yet Recruiting
Trial (India)
Publication Details nil
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-1β, IL-6, TNF-α, 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.

Composition of Majun Jograj Gugal (NFUM-I, Page 129-30)

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

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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

Composition of Raughan-e-Malkangani (NFUM-I, Page 197)

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S. No. Ingredients Botanical Name Quantity

1. Malkangani Celastrus paniculatus QS

Procurement, storage and dispensing

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