CTRI/2018/06/014450尚未招募2 期
A prospective open labelled phase II Non randomized clinical trial on herbal formulation of NANNARI VER OORAL KUDINEER for the treatment of VALI AZHAL KEEL VAYU(Rheumatoid arthritis)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- Principal
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Therapeutic efficacy of trial drug nannari ver ooral kudineer in vali azhal keel vayu
研究概览
简要总结
The study is A Prospective Open Labelled Phase II Non Randomized clinical study to evaluate the therapeutic efficacy of NANNARI VER OORAL KUDINEER 90ml TDS for 30 days in 40 patients during the trial period of 14 month that will be contacted in Goverment Siddha Medical College and hospital Palayamkottai Tirunelveli Tamilnadu The Primary outcome will be the therapeutic efficacy of trail drug NANNARI VER OORAL KUDINEER in VALI AZHAL KEEL VAYU The secondary outcome will be the evaluation of Sidha diagnostice parameters safety of trail drug Pharmacolocical and Biochemical analysis of trail drug
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
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Symmetrical joint involvement Arthritis of 3 or more joints Florid morning stiffness and swelling that lasts for few hours or days Pain joints swelling especially in the interphalangeal joints Pain criteria score should be greater than or equal to 6.
排除标准
- •Age below 18 and above 50 years Gouty arthritis Psoriatic arthritis Mixed connective tissue disorders SLE Extra pulmonary tuberculosis Other auto immune disease Chronic kidney disease Pregnant women and lactating mothers.
结局指标
主要结局
Therapeutic efficacy of trial drug nannari ver ooral kudineer in vali azhal keel vayu
时间窗: 30 days
次要结局
- Evaluation of siddha diagnostic parameters safety of trial drug pharmacological and Biochemical analysis of trial drug(30 days)
研究者
研究点 (1)
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