Comparative Evaluation of Varunadya Taila Matra Basti and Trikatu Gutika in Vatashtheela (Benign Prostatic Hyperplasia).
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Relief in the symptoms like frequency of urination in day and night time, urgency of
研究概览
简要总结
BPH is a non- cancerous disease and it is a part of normal ageing process. The most widely acknowledged cause is an imbalance between androgen and estrogen. It cause symptoms like increased frequency of micturition, nocturia, urgency, hesitancy etc. and signs like enlargement in Prostate size. This study is an interventional, open level, double group trial, "Comparative Evaluation of Varunadya Taila Matra Basti and Trikatu Gutika in Vatashtheela (Benign Prostatic Hyperplasia). The case will be selected randomly from OPD/IPD of Rishikul Campus Hospital, U.A.U, Haridwar (U.K.) India. The study will be intervened under two groups of 18 patients each, with one group receiving Varunadya Taila (Matra Basti) and the other group Trikatu Gutika (orally), duration of trial will be 21 days. Assessment criteria will be done on subjective and objective parameters. Subjective parameters on the basis of International Prostate Symptom Score (IPSS) and objective parameters on residual urine volume and prostate size volume.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 50.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- Male
入选标准
- •Age-50 or above 50 years. Sex.
- •Male Patients with classical signs & symptoms of Vatashtheela.
排除标准
- •Age below 50 years.
- •Patient with acute retention.
- •Known Malignant condition of Uro-genital system.
- •Patient associated with other systemic disorders- Renal Failure, immune-compromised patients, etc.
- •Patient not willing to undergo trial.
结局指标
主要结局
Relief in the symptoms like frequency of urination in day and night time, urgency of
时间窗: Zero, 7th, 14th, 21st day and after treatment.
urination & relief in signs such as enlargement of Prostate.
时间窗: Zero, 7th, 14th, 21st day and after treatment.
次要结局
- Expected improvement in the quality of life of(patients by relief in the symptoms like decrease)
研究者
Dr Ajay Kumar Gupta
Rishikul Campus, Haridwar.