Evaluation of safety and therapeutic efficacy of VAYU KEELAGA ILAKAM (Internal medicine) with ERUKKATHY THYLAM (External medicine) in the treatment of UTHIRA VATHA SURONITHAM(Rheumatoid arthritis).
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Assessment of pain will be Universal pain Assessment Scale.Other clinical signs and symptoms will be assessed by gradation method.
研究概览
简要总结
It is a single non randomized open -label trial to determine the Safety and Therapeutic efficacy of VAYU KEELAGA ILAKAM (internal medicine ) with ERUKKATHY THYLAM (external medicine) in patients with UTHIRA VATHA SURONITHAM (Rheumatoid arthritis).In the trial 30 Rheumatoid arthritis patients will be recruited and the trial drug vayu keelaga ilakam ,kottai pakkalavu (5 gm)will be administrated orally after food twice a day and Erukkathy thylam( required quantity ) will be applied over the affected joints for a periods of 45 days.During the study period all the study related data will be recorded and documented in a separate trial master file for each and every patients.During the trial period if the patient develop any adverse effect he/she will be immediately referred to the chairman,pharmaco-Vigilance Committee ,NIS.If it will be mild event ,the patient will be treated in OPD-NIS.if the event will be reserve ,the patient will be referred to nearby Government Hospital and the investigator will be take over the patient,until he/she will get recovery.the treatment will be provided with free of cost.the entire trial will be monitored by the research monitoring Committee of NIS.During this trial all the safety and efficacy parameters will be recorded in the CRF. After completion of the trial all the study related data will be analysed statistically. The outcome of this trial will be published in Indian Journal of Medical Research.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 20.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Insidious onset of polyarthritis with pain in the joints,Prolonged morning stiffness ( for 6 weeks or longer),Swelling of multiple involved joints (for 6 weeks or longer),Slow progressive signs of inflammation ,e.g.pain,Tenderness,warmth,eythymatous > 6 weeks,Symmetrical joints involvement,Swelling especially in inter phalangeal joints,RA factor positive or Negative,Patients willing to admission in IPD or willing to attend OPD,Patients willing to undergo Radiological investigations and other laboratory investigations,Patient willing to sign the informed consent stating that she/he will consciously stick to the treatment during 48 days but can opt out the trial his/her own conscious discretion.
排除标准
- •Pregnancy and lactation,Tubercular arthritis,Any other serious systemic illness like Cancer,Cardiac Diseases,osteoarthritis,Psoriatic arthritis,Gouty arthritis,Diabetic Mellitus,Hypertension,Characteristic deformities of hands ans feet in Rheumatoid arthritis,Systemic complication of Rheumatoid arthritis.
结局指标
主要结局
Assessment of pain will be Universal pain Assessment Scale.Other clinical signs and symptoms will be assessed by gradation method.
时间窗: After the 48 days of treatment , pain will be assessed by Universal pain Assessment Scale.Other clinical signs and symptoms will be assessed by gradation method.
次要结局
- secondary outcome will be assessed by comparing the parameters ,before and after treatment (laboratory investigations such as RA factor,ESR,CRP,ASO titre ,Anti-CCP,X-ray affected joints AP and Lateral view),reduction of clinical symptoms.(45 days)