A prospective open labelled, single arm, non-randomized, single centric, phase II clinical trial to determine the effectiveness of PIRAPPAN KIZHANGU KUDINEER in the management of UTHIRAVATHA SURONITHAM (RHEUMATOID ARTHRITIS)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
研究概览
简要总结
This is a prospective open labelled, single arm, non-randomized, single centric, PHASE II ,clinical trial to determine the effectiveness of PIRAPPAN KIZHANGU KUDINEER in the management of UTHIRAVATHA SURONITHAM (RHEUMATOID ARTHRITIS). After purifcation of trial drug, Pirappan kizhangu kudineer will be prepared and administered at the dosage of 60ml twice a day orally for 48 days for 40 patients (20 OP and 20 IP patients). The primary outcome will be to evaluate the therapeutic effectiveness of siddha herbal Pirappan kizhangu kudineer in the management of Uthiravatha suronitham (Rheumatoid arthritis). The secondary outcome will be to collect various siddha literatures and ,modern journals for literature review of Uthiravatha suronitham, to perform physicochemical, phytochemical, biochemical analysis of Pippan kizhangu kudineer,to evaluate safety profile for acute toxicity of Pirappan kizhangu kudineer, to evaluate pharmacological activities of Pirappan kizhangu kudineer,to study other co factors releated to disease like age,sex,dietary habits, family history and socioeconomic status , to evaluate siddha parameters (including envagai thervu) for uthiravatha suronitham, to evaluate modern parametric changes,to assess the quality of life of uthiravatha suronitham patients,to document bio statistical analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 20.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •1.Pain and early morning stiffness more than one hour .
- •2.Those who are willing to participate in this study 3.RA Factor test positive 4.Anti CCP positive 5.CRP elevated 6.ESR elevated.
排除标准
- •1.other degenerating joint diseases-osteoarthritis ,seronegative spondylo arthritis ,ankylosing spondylitis 2.Infectious joint diseases like tuberculosis,chronic poly arthritis in chickungunia viral infection 3.Metabolic joint diseases like gout .
- •4.patient who is on DMARD.(eg.methotrexate).
- •5.Pregnancy and lactating mother.
- •6.Chronic renal &liver diseases patients 7.Malignancy.
研究者
Dr R RAJA LAKSHMI
Government Siddha Medical College and Hospital, Palyamkottai
