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临床试验/CTRI/2024/08/072783
CTRI/2024/08/072783尚未招募Phase 3 4

Comparative evalutaion of Efficacy of Sahacharadi Tail Uttarbasti with Bala Tail Matarbasti in the Management of Vatashthila (Benign Prostatic Hyperplasia)

Mahatma Gandhi Ayurveda College and Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年8月28日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
A decrease in International Prostate System (I-PSS) Score

研究概览

简要总结

The study aims to compare the efficacy of Sahacharadi Tail Uttarbasti and Bala Tail Matrabasti in managing Vatashthila (Benign Prostatic Hyperplasia, BPH). Primary objectives include evaluating the efficacy of both treatments individually and comparing their effectiveness. Secondary objectives involve the pharmaceutical preparation and analysis of the medicated oils. Data will be sourced from classical texts and patients selected from the Shalyatantra OPD & IPD at Mahatma Gandhi Ayurved College, Wardha. The study design is a randomized clinical trial involving 40 patients divided into two groups: Group A receiving Sahacharadi Tail Uttarvasti and Group B receiving Bala Tail Matrabasti, both supplemented with Cap Kushmandadi Yoga. Patients will be assessed on days 0, 7, 14, and 21, with follow-ups on days 21, 28, and 35. Inclusion criteria include patients aged 35-85 with mild to moderate BPH, while exclusion criteria cover patients with severe BPH, systemic disorders, and other specific conditions. The assessment will utilize both subjective (AUA-SI or I-PSS) and objective (USG) criteria. Data analysis will involve the Wilcoxon Rank Sum Test, and the study’s results, discussion, and conclusions will be drawn post-analysis.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
35.00 Year(s) 至 85.00 Year(s)(—)
性别
Male

入选标准

  • Patients willing with Written informed Consent for will be taken.
  • Patient in the age group between 35-85years.
  • Patients with having mild to moderate BPH having Prostate size up to 50gm (Grade 3) will be included after screening.
  • Patients who are indicated for Matrabasti.

排除标准

  • 1.Patients of Grade 4 BPH i.e. above (50gm).
  • 2.Patient suffering from Systemic disorders like uncontrolled Diabetes mellitus, Tuberculosis, Hypertension.
  • 3.Urethral Stricture 4.Functional BOO (Bladder Outflow Obstruction) due to neurological conditions like CVA, Tabes Dorsalis, Parkinsonism, Disseminated Sclerosis, Loss of Neuro vesicle co-ordination, Syringomyelia, Alzheimers disease.
  • 5.Carcinoma of Prostate 6.Diverticulum of the bladder 7.Trigone Hyperplasia 8.Disability due to old age and serious systemic illness 9.Acute and chronic Retention of urine.

结局指标

主要结局

A decrease in International Prostate System (I-PSS) Score

时间窗: 1st follow up day 21 | 2nd follow up day 28 | 3rd follow up day 35

次要结局

  • an increase in quality of lie due to urinary symptoms(1st follow up day 21)

研究者

发起方
Mahatma Gandhi Ayurveda College and Hospital
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Sheetal Asutkar

Mahatma Gandhi Ayurveda College Hospital and Research Centre

研究点 (1)

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