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临床试验/CTRI/2024/07/070823
CTRI/2024/07/070823尚未招募2 期

A Phytochemical In Silico and Clinical Study of Mustadi Gana Kwatha and Swadamstradi Taila in the management of Benign Prostatic Hyperplasia

Faculty of Ayurveda Institute of Medical SciencesBanaras Hindu University1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2024年8月10日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
25
试验地点
1
主要终点
Disease specific subjective parameters based on IPSS score

研究概览

简要总结

On the basis of previous data and disease prevalence a total sample size of 25 has calculated after statistical analysis.Patients with signs and symptoms of BPH will be selected from OPD/IPD of department of Shalya Tantra and included in a single interventional group. Complete evaluation will be done by clinical examination, hematological, biochemical, radiological, urine analysis and uroflowmetry studies. Patients will be treated with Kala Basti for a period of 15 days;10 anuvasana basti with Swadamstradi Taila and 5 kashaya basti with Mustadi Gana Kashaya. After completion of therapy it will be assessed by subjective and objective parameters including urine flowrate(UFR), Post Voidal Residual Urine(PVRU) and size of prostate by USG. Statistical  analysis, Phytochemical ,In Silico study will be conducted on a computer through computational simulations. The biochemical, biophysical, biosaftey ,toxicity study and theraputics of Mustadi Gana Kashaya and Swadamstardi Taila will be studied.

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
40.00 Year(s) 至 80.00 Year(s)(—)
性别
Male

入选标准

  • diagnosed cases of BPH, without acute retention of urine all grades of BPH without acute retention of urine.

排除标准

  • Patients with bladder neck stenosis acute urinary retention known case of systemic diseases like TB Hepatitis B HIV Hepatitis C Cardiac diseases uncontrolled DM urethral stricture Neurogenic bladder ARF and CRF veneral diseases.

结局指标

主要结局

Disease specific subjective parameters based on IPSS score

时间窗: Basti will be administered for a period of 15 days followed by follow up every 4 weeks for a period of 12 weeks

objective parameters like weight of prostate and PVRU by USG whole abdomen with prostate and PVRU

时间窗: Basti will be administered for a period of 15 days followed by follow up every 4 weeks for a period of 12 weeks

次要结局

  • Relief in signs and symptoms of BPH(for a period of 3months)

研究者

发起方
Faculty of Ayurveda Institute of Medical SciencesBanaras Hindu University
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Saradhi R

Banaras Hindu University

研究点 (1)

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