CTRI/2023/07/055433招募中3 期
Efficacy of traditional Ayurvedic formulation (Divya Trighan) in patients with Hyperuricemia: a single-arm, open-label, prospective, observational study.
Patanjali Research Institute governed by Patanjali Research Foundation Trust1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年7月31日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- To assess the change in Uric acid levels after treatment with Divya Trighan in patients with Hyperuricemia.
研究概览
简要总结
This study is a single arm,open-label, prospective, observational study.Participants will be enroled for 6 months.The primary outcome includes improvement in laboratory parameters after 2 months of interventions. Secondary outcomes include assessment of quality of life of the patient
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •The subject with raised uric acid level in blood or urine (male: ≥ 8.5 mg/dl and female ≥ 7.3mg/dl)
- •Males or Females of age limit 18 to 60 years.
- •Patient agrees to provide informed consent.
- •Patient willing to participate in the study and ready to comply with study protocols.
- •No alcohol or drug dependency.
排除标准
- •Pregnancy or lactation, intent to become pregnant.
- •The subject with complications of pre-existing comorbidities or surgical intervention or undergone dialysis in last 3 month.
- •The subject with known history of uncontrolled DM and HTN.
- •The subject not willing to provide consent.
- •The subject not willing to comply with the protocol.
结局指标
主要结局
To assess the change in Uric acid levels after treatment with Divya Trighan in patients with Hyperuricemia.
时间窗: Baseline, 4 weeks, 8 weeks
次要结局
- •Change in the Quality of life of patients with SF-36 questionnaire(day 1,day 30,day 60)
研究者
研究点 (1)
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