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临床试验/CTRI/2020/04/024876
CTRI/2020/04/024876尚未招募2 期

A Comparative Pharmaceutico-Analytical and Clinical study of Mritasanjeevana Rasa and its modified formulation on Amavata (Rheumatoid Arthritis)

National Institute of Ayurveda Jaipur1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2020年1月10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
30
试验地点
1
主要终点
Alteration in Disease Activity Score (DAS28)

研究概览

简要总结

Amavata which resembles with Rheumatoid arthritis is a disease with high prevalence in middle age group, especially females. Rasashastra, pharmaceutical branch of Ayurveda provides potent and fast-acting medications against Amavata. This study aims at evaluating clinical efficacy of Mritasanjeevana Rasa (MRC) and its modified formulation (MRM) on Amavata (Rheumatoid Arthritis). AIM To comparatively evaluate clinical effect of MRC and MRM on Amavata (Rheumatoid Arthritis) OBJECTIVES 1. To review literature on Mritasanjeevana Rasa. 2. To prepare classical formulation of Mritasanjeevana Rasa (MRC) and modified formulation of Mritasanjeevana Rasa (MRM) 3. To analyze the prepared samples of both formulations 4. To assess changes in signs and symptoms of Amavata 5. To assess changes in investigatory parameters Null Hypothesis (H0) – There is no significant efficacy of MRC and MRM on Amavata. Alternative Hypothesis (H1) – MRC and MRM are significantly effective on Amavata.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Patients present with classical signs & symptoms of Amavata.
  • Patients willing to give informed consent to participate for 28 days.

排除标准

  • Patients present with systemic diseases like Diabetes mellitus, Cardiac Disease, Hypertension, etc.
  • Patients on prolonged ( > 6 weeks) medication with corticosteroids, etc.

结局指标

主要结局

Alteration in Disease Activity Score (DAS28)

时间窗: 28 days

次要结局

  • Changes in signs and symptoms(28 days)

研究者

发起方
National Institute of Ayurveda Jaipur
申办方类型
Government medical college

研究点 (1)

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