A Single Arm Clinical Trial To Assess the Efficacy Of Navakarshika Ksheera Basti In Gouty Arthritis In Relation To Gout Impact Scale & Biomarker Serum-Urate Transporter 1
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Reduction in GIS score
研究概览
简要总结
the protocol is proposed to assess the effect of Navakarshika Ksheera Basti in Gouty arthritis in relation to Gout Impact Scale & URAT 1 biomarker. Gout is a prevalent condition that requires effective management to improve the quality of life of affected individuals. While modern science has developed effective treatments for gout, these therapies are often associated with a range of side effects, including diarrhea, elevated alanine aminotransferase (ALT) levels, hypertriglyceridemia, dry mouth, and oral ulcers. URAT1 inhibitors are among these treatments. This study aims to investigate whether the traditional treatment referred to as ’basti’ has an inhibitory effect on the URAT1 protein, which is released as a result of metabolic changes associated with gout.
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
- 35.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Clinically Diagnosed of gout using ACR/EULAR gout classification criteria.
- •Subjects fit for basti karma.
排除标准
- •In subjects where Chronicity of the disease is more than 6 years, associated Tophi & complete joint destruction/crippling deformity.
- •Participants suffering from severe systemic illness like uncontrolled DM, HTN, malignancy, autoimmune disease, Chronic Kidney Diseases etc.
- •Patients taking DMARDs & URAT 1 inhibitors for at least 6 days.
结局指标
主要结局
Reduction in GIS score
时间窗: 1st, 7th & 21st day of intervention
次要结局
- Reduction in Serum URAT 1 levels & Uric Acid levels(1st, 7th & 21st day of intervention)
研究者
Dr Sawant Sneha Dilip
Amrita School Of Ayurveda