To evaluate the Safety and efficacy of two Unani formulations Majun Jograj Gugal and Raughan-e-Malkangani in Waja‘al-Mafasil (Rheumatoid Arthritis)

Phase 2

Not yet recruiting

• Conditions: Rheumatoid arthritis with rheumatoid factor, unspecified, Waja‘al-Mafasil (Rheumatoid Arthritis),

• Registration Number: CTRI/2015/03/005638
• Lead Sponsor: Central Council for Research in Unani Medicine New Delhi

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. 

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

|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)

| | | | |

| --- | --- | --- | --- |

|**S. No.**

**Ingredients**

**Botanical Name**

**Quantity**

|1.

Malkangani

*Celastrus paniculatus*

QS

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01-04
• Last Update Posted: 2018-04-12

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• •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

• •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).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement in signs and symptoms of Waja‘al-Mafasil (Rheumatoid Arthritis)	12 WEEKS

Secondary Outcome Measures

Name	Time	Method
Haematological and biochemical assessments for safety	ï‚· Improvement in the feeling of well-being of the patient

Trial Locations

Locations (3)

Central Research Institute, Lucknow; 🇮🇳 Lucknow, UTTAR PRADESH, India

Clinical Research Unit; 🇮🇳 Meerut, UTTAR PRADESH, India

Regional Research Institute of Unani Medicine (RRIUM), Patna; 🇮🇳 Patna, BIHAR, India

Central Research Institute, Lucknow

🇮🇳Lucknow, UTTAR PRADESH, India

DR A V ALVI

Principal investigator

09455282012

abalvi@rediffmail.com