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临床试验/CTRI/2025/07/090087
CTRI/2025/07/090087尚未招募3 期

Evaluation of Efficacy of Varunadi Kwatha in the Management of Vatasthila w.s.r. to Benign Prostatic Hyperplasia.

Vaidya Yagya Dutt Sharma Ayurved Mahavidyalaya1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年7月4日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
Change of Frequency of Micturition , Change in Nocturia episodes,change in IPSS Score

研究概览

简要总结

Vatasthila has symptoms similar to Benign Prostatic Hyperplasia (BPH), which is a non-malignant enlargement of the prostate gland commonly seen in elderly males. BPH includes obstructive and irritative urinary symptoms like urinary retention, nocturia, urgency, and incomplete bladder evacuation. In Ayurveda, Vatasthila is described under Mutraghata. Modern treatments have side effects and surgical complications. Varunadi Kwatha, mentioned in Chakradatta Ashmari Adhyaya, has Kaphahara, Lekhana, and Mutrala properties. It acts through Vatanulomana, Shothahara, and Deepana effects. A randomized, single-blind, controlled clinical trial will be conducted on 40 patients for 45 days. Follow-ups will be on Day 15, 30, and 45. Assessment will be based on IPSS score, urinary frequency, urgency, nocturia, prostate size, and residual urine volume.

研究设计

研究类型
Interventional
分配方式
Other
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

  • 1.Patients age between 40 to 70 years 2.USG suggestive of BPH 3.Patients not willing for surgery 4.Post-voidal residual urine upto 100 ml 5.Frequency of urine more then 2 times and less than 5 times at night.

排除标准

  • 1.Patitents age below 40 or above 70 years 2.Cases of BPH in which surgery is indicated 3.Patients diagnosed with carcinoma of the prostate 4.Patients having acute urinary retention 5.Cases with Severe UTI 6.Patients with urethral stricture.

结局指标

主要结局

Change of Frequency of Micturition , Change in Nocturia episodes,change in IPSS Score

时间窗: Baseline (Day 0), 15th Day, 30th Day, and 45th Day (End of Treatment)

次要结局

  • To assess cost-effectiveness of Varuna Kwatha.(To evaluate reduction in symptom recurrence.)

研究者

发起方
Vaidya Yagya Dutt Sharma Ayurved Mahavidyalaya
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Vimal Kumar

Vaidya Yagya Dutt Sharma Ayurved Mahavidhalaya Khurja district Bulandshahar GT road

研究点 (1)

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