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临床试验/CTRI/2023/11/059780
CTRI/2023/11/059780尚未招募2 期

Phase II non randomized open clinical evaluation of siddha medicine maha analuruva chooranam for the management of uthiravatha suronitham (Rheumatoid arthritis)

Dr Dharani P1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年11月24日最近更新:

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
主要终点
The outcome will be mainly assessed by reduction in clinical symptoms such as severity of pain,reduction of swelling and morning stiffness.

研究概览

简要总结

Rheumatoid arthritis is an auto immune disorder and a chronic multisystem disease, with a variety of systemic manifestations.The prevalence of RA in India is 0.5-0.75 %. Females are more affected than male in the ratio of 3:1. Thus in Siddha system of medicine, there are unique combinations of medicine which have the solution to RA. One such combination is MAHA ANALURUVA CHOORANAM which will be cost effective and reliable.

The aim of the study is the management of UTHIRAVATHA SURONITHAM compared with RHEUMATOID ARTHRITIS  with the Siddha medicine MAHA ANALURUVA CHOORANAM and the objective is to determine the therapeutic efficacy and safety profile of Siddha medicine MAHA ANALURUVA CHOORANAM in the  treatment of UTHIRAVATHA SURONITHAM (RHEUMATOID ARTHRITIS )

As the literary evidences support the usage of medicine in the disease, a hyopothesis is created in such a way that the efficacy of the MAHA ANALURUVA CHOORANAM will be better solution for UTHIRAVATHA SURONITHAM (RHEUMATOID ARTHRITIS).

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
18.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • 18 to 50 years All genders Morning stiffness more than 1 hour Arthritis of more than 3 joints Symmetrical arthritis Patients positive for anti-CCP.

排除标准

  • Rheumatic fever Psoriatic arthropathy Gouty athritis Any other serious systemic illness Pregnant women and lactating mothers Type 2 diabetes mellitus The above criteria will be excluded clinically or based on the available medical reports.

结局指标

主要结局

The outcome will be mainly assessed by reduction in clinical symptoms such as severity of pain,reduction of swelling and morning stiffness.

时间窗: 3 weeks

次要结局

  • Assesing the improvement of patient from severe to moderate,moderate to mild through universal pain assessment scale (VISUAL ANALOGUE SCALE) and reduction in Anti-CCP levels which helps to ensure the wellness of patient.(7 Weeks)

研究者

发起方
Dr Dharani P
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dharani P

Government siddha medical college, Arumbakkam, Chennai 106.

研究点 (1)

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