CTRI/2025/12/098985招募中不适用
Effect of two polyherbal Unani formulations used for Waja al Mufasil (Rheumatoid Arthritis/L-4) on serum biomarkers, inflammasomes activation, pyroptosis and endothelial dysfunction - A clinical and in-vitro study to understand their mechanism of action
Central Council of Research in Unani Medicine1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2026年1月1日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 48
- 试验地点
- 1
研究概览
简要总结
The present study will help to establish the possible mechanism of action of the herbal Unani formulations. This type of study will help to understand the molecular mechanism of these unani formulations used for wajalmufasil (rhematoid arthritis). this type of study will provide scientific validation and will help to create evidence-based recommendations for these unani formulations. This type of study will be the essential prerequisite
for a larger sample size mechanistic study. Moreover, this type of study will help guide the clinical and therapeutic management of RA and ultimately benefit the broader
population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
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.
- •ACR-EULAR criteria with moderate disease activity only.
- •Definite clinical synovitis (pain, swelling, tenderness) in at least 1 joint.
- •A total score of atleast 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 0-3).
排除标准
- •Rheumatoid arthritis with extra-articular manifestations, joint deformities, and advanced radiological lesions (e.g., Joint subluxation and collapse).
- •Obese patients BMI
- •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 before 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 the study drug or any of its ingredients.
研究者
Towseef Amin Rafeeqi
CCRUM-Regional Research Institute of Unani Medicine Srinagar
研究点 (1)
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