跳至主要内容
临床试验/CTRI/2020/10/028751
CTRI/2020/10/028751已完成不适用

Single Blind Randomized Experimental Study to Assess the Efficacy of Simarouba glauca 6C, 12C and 30C in the Treatment of Rheumatoid Arthritis Patients

Vinayaka Missions Homoeopathic Medical College and Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2020年1月11日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
Reduction in Serum Rheumatoid Factor and Erythrocyte Sedimentation Rate levels of each Patient after the completion of treatment

研究概览

简要总结

Rheumatoid arthritis (RA) isthe most common inflammatory arthritis and autoimmune disease that isassociated with progressive disability, systemic complications, early death andsocioeconomic costs.[1]

RA occurs in 0.5-1.0% of the adult population worldwideand is more common in women.[2,3] Its Indian prevalence is rangingbetween 0.19-2.50%. The peak incidence is between the ages of 20 and 40, themost productive years of adulthood.[3,4]

Complex aetiological factors like genotype(50%),environment, age, gender, family history, smoking, etc., can cause RA. These triggersentail several inflammatory cascades leading to persistent synovial inflammationand associated damage to articular cartilages.[5] About80% of RA patients are Seropositive for Rheumatoid Factor (Normal range: 0-20 U/ml)and its presence predicts a more aggressive & destructive course.[6]

Patients often complain of pain & early morning jointstiffness lasting >1 hour. Typically the small joints of hands and feet are affectedwith a polyarticular (>5 joints) symmetric distribution. Later it may affectthe large joints.[7]

The confirmative diagnosis may be done with ‘2010American College of Rheumatology / European League against RheumatismClassification Criteria for RA’.[8]

RA has a significant negative impact on the ability toperform daily activities, including work & household tasks, and health relatedquality of life. The goal of treatment in RA patients is to eliminate symptoms,slow disease progression and optimize quality of life.

Simarouba galuca (Lakshmi Taru) is a herb wellknown for its medicinal uses including Rheumatoid Arthritis.[10,11] RecentIn-vitro studies have evidenced the anti-inflammatory activity of its extractsin Arthritis Models.[12,13] But no evidence is available for itsHuman Use. This information intended me to do a Comparative Experimental Studyof this medicine in different Homoeopathic potencies, to check itsEffectiveness and Anti-inflammatory property in RA patients.

Bibliography:

**1.**McInnes IB, Schett G. The pathogenesis of rheumatoid arthritis. NewEngland Journal of Medicine. 2011-Dec 8;365(23):2205-19.

**2.**Smolen JS, Aletaha D, et.al. Rheumatoid arthritis. Lancet[Internet].2016; 388 (10055):2023-2038.

**3.**Handa R, et.al. Literature review of rheumatoid arthritis inIndia. International journal of rheumatic diseases. 2016-May;19(5):440-51.

4. Carmona L, et.al.(2010). Rheumatoid arthritis. Best Practice & Research ClinicalRheumatology, 24(6):733-45.

**5.**Scott DL, et.al. (2010). Rheumatoid arthritis. The Lancet,376(9746):1094-1108.

**6.*Firestein GS. Evolving concepts of rheumatoid arthritis. Nature.*2003-May;423(6937):356-61.

**7.**Ankoor S. et.al. Rheumatoid Arthritis. Harrison’s Principles ofInternal Medicine. 19th Edition. McGraw Hill. 2015:2136-37.

**8.**Aletaha D, et al. 2010 Rheumatoid arthritis classificationcriteria: American College of Rheumatology/European League Against Rheumatismcollaborative initiative. Arthritis & rheumatism. 2010-Sep;62(9):2569-81.

9.https://www.medassignments.com/rheumatoid-arthritis-7111 (Last accesses 20.07.2020)

**10.**Sharanya VK, et.al. A pharmacological review on simarouba glauca.Int.J.Pharma.Res.Rev. 2016-Jun;5:32-6.

11. Bhattacharyya RK, Debbarma N, et.al.  Medicinal plants-Simarouba glauca and Dilleniaindica. *Int.J. Minor Fruits, Medicinal and Aromatic Plants.*2018;4(2):42-5.

研究设计

研究类型
Interventional
分配方式
Other
盲法
Participant Blinded

入排标准

年龄范围
25.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • Clinically Diagnosed Patients fulfilling the 2010 American College of Rheumatology / European League Against Rheumatism Classification Criteria for Rheumatoid Arthritis.

排除标准

  • Patients with Systemic Complications and Deformities.
  • Patients with Extra-articular manifestations.
  • Patients under Chronic medication for Rheumatoid Arthritis.

结局指标

主要结局

Reduction in Serum Rheumatoid Factor and Erythrocyte Sedimentation Rate levels of each Patient after the completion of treatment

时间窗: 90 Days

次要结局

  • Reduction in the ‘Rheumatoid Arthritis Impact of Disease (RAID) Questionnaire Score’(90 Days)

研究者

发起方
Vinayaka Missions Homoeopathic Medical College and Hospital
申办方类型
Private medical college

研究点 (1)

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