Treatment of Pain in joints with Unani medicine Habb e Mafasil and Zamad e Muhallil
- Conditions
- Rheumatoid arthritis, unspecified,
- Registration Number
- CTRI/2023/04/051555
- Lead Sponsor
- Central Council for Research in Unani Medicine CCRUM New Delhi
- Brief Summary
This study is designed as a single centric open 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 every two weeks for 12 weeks. This includes subjective assessment of general well being and physical examination . 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.
**Composition of *Habb-e-Mafasil***
| | | | |
| --- | --- | --- | --- |
|**S. No.**
**Ingredients**
**Botanical / English Name**
**Quantity**
|1.
Suranjan Talkh
*Colchicum luteum* Baker.
10 g
|2.
Sibr
*Aloe vera* Linn.
10 g
|3.
Turbud Safaid
*Operculina turpethum* Linn.
10 g
|4.
Sana
*Cassia angustifolia* Vahl.
10 g
|5.
Afsanteen
*Artemisia absinthium* Linn.
10 g
|6.
Namak Sanbhar
Sanbhar Salt
10 g
|7.
Shahm-e-Hanzal
*Citrullus colocynthis* Linn.
10 g
|8.
Ajmod
*Apium graveolens* Linn.
10 g
|9.
Aab-e-Garm
Warm Water
Q.S.
**Composition of *Zamad-e-Muhallil***
| | | | |
| --- | --- | --- | --- |
|**S. No.**
**Ingredients**
**Botanical / English Name**
**Quantity**
|1.
Ikleel-ul-Malik
*Astragalus hamosus* Linn.
1 kg.
|2.
Babuna
*Matricaria Chamomilla* Linn.
1 kg
|3.
Asgand Nagori
*Withania somnifera* Linn.
1 kg
|4.
Mako
*Solanum nigrum* Linn.
1 kg
|5.
Tukhm Khatmi
*Althaea officinalis* Linn.
1 kg
|6.
Rewand Chini
*Rheum emodi* Linn.
1 kg
|7.
Muqil
*Commiphora wightii* Arn.
250 g
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 240
- Patients of either sex in the age group 18-65 years.
- Patients having Wajaul Mafasil (RA) as defined by the following ACR-EULAR criteria: Definite clinical synovitis (pain, swelling, tenderness) in at least 1 joint 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: Number and site of involved joints (range 0-5) Serological abnormalities (range 0-3) Elevated acute-phase reactants (range 0-1) Duration of symptoms (range 0-1).
- Rheumatoid arthritis with extra-articular manifestations, joint deformities, and advanced radiological lesions (e.g. joint subluxation and collapse).
- Obese subjects (BMI ≥30) 3.
- 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, HIV infection etc 5.
- 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 S.
- Creatinine, BUN, S.
- Bilirubin outside the reference range, and SGOT, SGPT raised >2.5 times the ULN.
- History of hypersensitivity to study drug or any of its ingredients.
- Pregnant and lactating women.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method the efficacy of study drugs will be assessed on the basis of improvement in symptoms i.e. VAS (0-100 mm) for joint pain and DAS28 (0-10) for clinical disease activity. At every 2 weeks, i.e. at days 14, 28, 42, 56, 70 and on 84
- Secondary Outcome Measures
Name Time Method Haematological and biochemical assessment for safety assessment At baseline and after 12 weeks
Trial Locations
- Locations (1)
Regional Research Institute of Unani Medicine (RRIUM)
🇮🇳Bhadrak, ORISSA, India
Regional Research Institute of Unani Medicine (RRIUM)🇮🇳Bhadrak, ORISSA, IndiaDr Mohd TariqPrincipal investigator8984112448drtariqbdk@gmail.com