A comparative clinical study of Panchsam Churna and Vaishvanar Churna with Maharasnadi Kwath in Amavata
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Changes in Clinical presentation of Amavata assessed through-
研究概览
简要总结
This is an open-label, double-arm comparative clinical trial to evaluate the efficacy of Panchsama Churna and Vaishvanar Churna with Maharasnadi Kwath in the management of Amavata (rheumatoid arthritis). A total of 60 patients fulfilling the EULAR criteria for RA will be randomly divided into two groups of 30 each. One group will receive Panchsama Churna with Maharasnadi Kwath, and the other will receive Vaishvanar Churna with Maharasnadi Kwath for 30 days. The efficacy will be assessed based on subjective symptoms like sandhi shool, sandhi jadyata, jwar, sparshasahtya, DAS-28, RAPID-3, RA factor, CRP, grip strength, and foot pressure. Follow-ups will be done on Day 15 and Day 30. The aim is to compare both regimens and provide a cost-effective, safe, and efficient Ayurvedic intervention for Amavata.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with classical features of Amavata like Angmard, Aruchi, Trishna, Aalasya, Gaurava, Jwar, Shotha, Stabdhta.
- •Patients who fullfill the EULAR Classification Criteria for RA with less than 5 years of chronicity.
- •Patients of either sex and socio-economic status with age between 20 and 65 years.
- •Willing and able to participate in the study and ready to sign informed consent form.
排除标准
- •1 Patients with uncontrolled Hypertension (more than 160/100 mm of Hg) and diabetes mellitus 2 Patients diagnosed with other types of arthritis like gouty arthritis, tuberculous arthritis etc.
- •3 Patients with bone deformities like Swan neck deformity, Boutonniere deformity and rheumatic nodules 4 Patients on prolonged medication with corticosteroids, antidepressants, anticholinergics, etc.
- •or any other drugs that may have an influence on the outcome of the study.
- •5 Patients who have a past history of any major systemic disorder like CA, CRF, Liver cirrhosis, CAD etc.
- •6 Pregnant and lactating mother.
结局指标
主要结局
Changes in Clinical presentation of Amavata assessed through-
时间窗: base line assessment ( day 0) | mid treatment assessment (day 15) | post treatment assessment (day 30)
1. Change in DAS 28 Score
时间窗: base line assessment ( day 0) | mid treatment assessment (day 15) | post treatment assessment (day 30)
2. Change in RAPID 3 Score
时间窗: base line assessment ( day 0) | mid treatment assessment (day 15) | post treatment assessment (day 30)
3. Improvement in Objective Parameters like RA Factor and CRP
时间窗: base line assessment ( day 0) | mid treatment assessment (day 15) | post treatment assessment (day 30)
4. Change in Subjective Parameters like- Sparshasahyata, Sandhishoth, Gauravata, Aruchi, Jwar, Sandhi shool
时间窗: base line assessment ( day 0) | mid treatment assessment (day 15) | post treatment assessment (day 30)
次要结局
- improvement in quality of life assessed through patient reported feedbackregarding daily activities and overall wellbeing(base line assessment ( day 0))
研究者
Pranika Singh
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan