Standardization and Clinical Evaluation of Siddha Formulations for Urolithiasis /Kalladaippu.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Expulsion of stones or Reduction in the number and size of the stones.
研究概览
简要总结
This study is a non randomized non comparative study with two Siddha formulations Sindhuvallathy Mezhugu and Kalladaippu Kudineer are available in Siddha classical texts existing for longer period. But there is no scientific data is documented about these formulations. This study aimed to evaluate the efficacy of the study drugs for urolithiasis. After the preliminary drug standardization the clinical study is Started at The National Institute of Siddha Tambaram. The primary outcome measure is either the Expulsion of stones or Changes in the number and size of the stones with 45 days drug treatment.
详细描述
Objectives:
Primary Objectives. To assess the efficacy of sindhu vallathy mezhugu and Kalladaippu kudineer in Urolithiasis.
Secondary objectives
- To standardize the study drugs.
- To observe the adverse effects if any
Methods of proposed research:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age> 18 years
- •both gender
- •diagnosed ultrasonographically/radiographically with visible calculi of >5mm
- •with or without clinical symptoms .
排除标准
- •Patients with severe pain and not responding to pain killers
- •Bilateral Calculi obstruction requiring immediate surgery,
- •Existing renal failure,
- •Pregnant and lactating women,
- •Age<18 years,
- •known hepatic and cardiac diseases,
- •Subjects those who are not willing to give informed consent
- •Women those who are planning for pregnancy .
研究组 & 干预措施
Sindhuvallathy mezhugu
Sindhuvallathy mezhugu (SVM) 500 mg Twice daily per Oral 45 days duration
干预措施: Sindhuvallathy mezhugu ( SVM) (Drug)
Kalladaippu Kudineer
Kalladaippu Kudineer (KK) 130 ml decoction Twice daily Per oral 45 days Duration
干预措施: Kalladaippu Kudineer (KK) - (Drug)
Sindhuvallathy + Kalladaippu Kudineer
Sindhuvallathy mezhu -500 mg capsules twice daily + Kalladaippu kudineer -130 ml decoction twice daily-per oral for 45 days.
干预措施: Sindhuvallathy mezhugu ( SVM) (Drug)
Sindhuvallathy + Kalladaippu Kudineer
Sindhuvallathy mezhu -500 mg capsules twice daily + Kalladaippu kudineer -130 ml decoction twice daily-per oral for 45 days.
干预措施: Kalladaippu Kudineer (KK) - (Drug)
结局指标
主要结局
Expulsion of stones or Reduction in the number and size of the stones.
时间窗: 0,15,30,45 days post drug treatment
The recruited subjects will be assessed for their parameters from base line and 15th day 30th day and 45th day of drug treatment. It will be measured either the expulsion of stones and/or reduction in number and size of stones from the baseline. The Ultra sound abdomen or X-ray will be done on 0 day and 45th day only.
次要结局
- Reduction in pain and symptom score(0 15 30 45 days)
- Changes in other investigations(0 15th 30th 45th days)
- Prevention of stone forming factors within the study period.(0,15th ,30th and 45th day)
研究者
Dr. K. Rajalakshmi
Assistant professor
Tamil Nadu Dr.M.G.R.Medical University