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临床试验/CTRI/2025/01/079141
CTRI/2025/01/079141招募中2/3 期

Effect of Kalyanaka kshara with Virataradi kashaya as an adjuvant therapy for improving the quality of life in CA Prostate A pre test post test design

VPSV AYURVEDA COLLEGE KOTTAKKAL1 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2025年2月21日最近更新:

试验速览

阶段
2/3 期
状态
招募中
发起方
入组人数
11
试验地点
1
主要终点
Improve in quality of life assessed through questionnaire EORTC-QLQ-C-30 and EORTC-QLQ-PR25

研究概览

简要总结

Effect of Kalyanaka kshara with Virataradi kashaya as an adjuvant therapy for improving the quality of life in CA Prostate -A pre test -post test design. Prostate cancer is the second most commonly diagnosed cancer globally. The diagnosis as well as the treatment affect both general quality of life and health related specific quality of life including urinary, bowel and sexual domains. The objective of this study is to validate the effect of Kalyanaka kshara with Virataradi kashaya as an adjuvant therapy for improving the quality of life in CA Prostate. The European Organisation for Reasearch and Treatment of Cancer EORTC-QLQ-PR25 is a Prostate cancer specific module, supplementary to the core quality of life questionnaire EORTC-QLQ-C-30, will be used in the study. The study design will be a single group pre test -post test trial. Including 11 participants in the age group of 40 to 70 years selected from the VPSV’s Aryavaidyasala Special OP, Charitable Hospital, Kottakkal. Quality of life assessment of the participants will be done on the 0 th,31st, and 61st days. The data will be analysed using the most appropriate statistical test.

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 70.00 Year(s)(—)
性别
Male

入选标准

  • Subjects diagnosed with CA Prostate,age group of 40-70 year and with informed consent.

排除标准

  • Uncontrolled DM HbA1c greater than 7.5 HTN BP greater than 150/100 mmHg Chronic kidney diseases.

结局指标

主要结局

Improve in quality of life assessed through questionnaire EORTC-QLQ-C-30 and EORTC-QLQ-PR25

时间窗: 0th 31st and 61st days

次要结局

  • To observe whether the combination of drug affects the urine pH using urine routine examination(0th and 61st days)

研究者

发起方
VPSV AYURVEDA COLLEGE KOTTAKKAL
申办方类型
Other [Aided College ]
责任方
Principal Investigator
主要研究者

Dr Sai Nandana MC

VPSV Ayurveda College Kottakkal

研究点 (1)

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