Clinical Validation of Unani Pharmacopoeal formulation Habb-e-Suranjan in Waja ul Mafasil (Rheumatoid Arthritis)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 240
- 试验地点
- 3
- 主要终点
- Improvement in sign and symptoms of Waja ul Mafasil (Rheumatoid Arthritis)
研究概览
简要总结
This study is a multicentric 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. 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-Suranjan(NFUM-I, Page 33)
| S. No. |
Ingredients
Botanical / English Name
Quantity
|1.
Suranjan Shirin
Colchicum autumnale Linn.
1 Part
|2.
Post-i Halela Zard
Terminalia citrina
1 Part
|3.
Shahm-i Hanzal
Citrullus colocynthis (Linn.) Schrad.
1 Part
|4.
Muqil
C. mukul (Hook. ex Stocks) Engl.
1 Part
|5.
Turbud
Operculina turpethum (Linn.) S.
1 Part
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of either sex in the age group 18-65 years.
- •Patients having Waja‘al-MafÄsil (Rheumatoid arthritis) as defined by the following ACR-EULAR criteria (Annexure IV): (i) Definite clinical synovitis (pain, swelling, tenderness) in at least 1 joint (ii) Absence of an alternative diagnosis for the observed synovitis (arthritis) (iii) 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).
排除标准
- •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, HIV infection etc
- •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.
结局指标
主要结局
Improvement in sign and symptoms of Waja ul Mafasil (Rheumatoid Arthritis)
时间窗: Six Weeks
次要结局
- Hematological and biochemical assessments for safety(6 weeks)