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临床试验/CTRI/2025/02/080464
CTRI/2025/02/080464尚未招募2/3 期

AN OPEN-LABEL RANDOMISED CONTROL CLINICAL TRIAL TO ASSESS THE EFFICACY OF PANCHASAMA CHURNA ALONG WITH MAHARASNADI KWATHA AND SIMHANADA GUGGULU IN THE MANAGEMENT OF PAIN IN AMAVATA (RHEUMATOID ARTHRITIS) AFTER VIRECHANA AND IN SILICO EVALUATION OF PANCHASAMA CHURNA

Dr Anju S Raj1 个研究点 分布在 1 个国家目标入组 132 人开始时间: 2025年3月12日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
132
试验地点
1
主要终点
• Reduction in Universal pain assessment

研究概览

简要总结

the study is a randomised control clinical trial to assesse the efficacy of Panchasama churna along with Maharasnadi kwatha and Simhanadagugguluin the management of pain in Amavata (Rheumatoid arthritis) after *Virechana .*Primary endpoint will beReduction in Universal pain assessment. Secondary endpoint will be Reduction of RA factor, CRP, ESR ,Improvement in DAS 28 scor , To provide relief in the cardinal symptoms of Amavata (RA) , Improvement in the quality of life of Amavata patients by using SF 36. Total partcipant for the trial will be 136 .

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

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

入选标准

  • Patients aged 21 to 60 years wishing to participate in the trial with a diagnosis of rheumatoid arthritis.
  • Includes both seropositive and seronegative cases.
  • Patients having the clinical manifestation of Amavata (RA) according to Ayurvedic classics -Sandhishool (pain), Shotha (swelling), Sparshasahata (tenderness) and Stabdhata (stiffness),Vrishichikadansavata vedana(pain like scorpion sting), Agnimandya (poor digestion) , Aruchi(anorexia), Gaurav(Feeling of heaviness of body),Utsaha Hani(lack of interest),Mukha vairasya(Perverted taste).

排除标准

  • patients unwilling to participate pregnant and lactating women Patients with major complications such as extra-articular manifestations are also excluded.
  • Patients with other systemic complications of RA like RHD, Rheumatic fever, pleural pericardial disease.
  • Patients diagnosed with other arthritis like gouty arthritis, tuberculous arthritis, and psoriatic arthritis.
  • patients with poorly controlled diabetes and hypertension patients who is taking medicines for modern ailments.

结局指标

主要结局

• Reduction in Universal pain assessment

时间窗: baseline,after virechana ,4 weeks after virechana

次要结局

  • Reduction of RA factor, CRP, ESR(Improvement in DAS 28 score)

研究者

发起方
Dr Anju S Raj
申办方类型
Research institution
责任方
Principal Investigator
主要研究者

Dr Anju S Raj

All India Institute of Ayurveda

研究点 (1)

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