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临床试验/CTRI/2024/02/063232
CTRI/2024/02/063232尚未招募3 期

Assessment of efficacy of methotrexate with ayurvedic preparation (Singhnad guggul, Rasna saptak kwath, Erand oil) versus methotrexate with placebo in early rheumatoid arthritis: an exploratory double-blind randomized placebo-controlled trial

Prativa Priyadarshani Sethi1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2024年3月10日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
160
试验地点
1
主要终点
DAS28ESR ≤3.2

研究概览

简要总结

Rheumatoid arthritis (RA) is a chronic autoimmune disorder affecting small joints. Mortality and morbidity rates are higher due to cardiovascular events. Early, aggressive treatment with disease-modifying anti-rheumatic drugs (DMARDs) is crucial. Ayurveda, an ancient Indian system, is being explored as an adjunct therapy. While some studies support its efficacy, others are inconclusive. Meta-analyses suggest combining Ayurveda with conventional DMARDs improves pain, function, and inflammation. The aim of this study is to investigate whether combination ofmethotrexate with ayurvedic preparation (Singhnad guggul, Rasna sapthak kwath, Erand oil) would result in better efficacy compared to methotrexate alone among patients with early rheumatoid arthritis over 24 weeks. We hypothesize that Methotrexate with Ayurveda will yield better responses and low disease activity at 24 weeks than methotrexate alone.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Double

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • age more than 18years, early RA within 1 year of diagnosis.

排除标准

  • 未提供

结局指标

主要结局

DAS28ESR ≤3.2

时间窗: Baseline and 24 weeks

DAS28CRP ≤3.2

时间窗: Baseline and 24 weeks

次要结局

  • DAS28ESR ≤ 2.6(DAS28CRP ≤ 2.6)

研究者

发起方
Prativa Priyadarshani Sethi
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Prativa Priyadarshani Sethi

All India Institute of Medical sciences, Rishikesh

研究点 (1)

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