CTRI/2025/01/079491尚未招募2 期
Efficacy of Kabab Chini in Lower Urinary Tract Symptoms associated with Benign Prostatic Hyperplasia: A randomized, double-blind, placebo-controlled clinical trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Improvement in IPSS Score
研究概览
简要总结
Purpose: To Evaluate the Efficacy of Kabab Chini in Lower Urinary Tract Symptoms associated with Benign Prostatic Hyperplasia
Design: A randomized double-blind placebo controlled clinical trial
Intervention: A test group will be given Kabab chini 3gm in two divided doses, and a Placebo (Wheat flour) will be given in the same as of test group.
Main Outcome Measures:
The primary outcomes: Improvement in IPSS Score
Secondary outcomes: Prostate size reduction as visualized in USG, Reduction in PVR (Pre and Post), Improvement in Activities of Daily Living (ADL) assessed by BPH- specific QoL scale
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 40.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- Male
入选标准
- •Male patients of age more than 40 and less than 80 years Patients with a history of LUTS (Urgency, Frequency, Nocturia, Incontinence, Weak stream, Straining, Dribbling of urine) attributable to BPH Mild (1 to 7) and Moderate (8 to 19) cases, according to IPSS PVR less than 150 ml and weight of prostate more than 20 gm as seen in USG BPH Grade I, II and III Patients willing to give their written informed consent and are able to do follow-up.
排除标准
- •Subjects having urinary retention (PVR more than 150 ml), hematuria, urinary tract infection, renal and hepatic impairment, urinary tract calculi, and congenital deformities of the urogenital tract or any abdominopelvic pathology other than BPH Known cases of bladder or urethral strictures, neurologic bladder dysfunction, and prostate and bladder cancer Subjects with a history of use of drugs with antiandrogenic properties and prostate surgery or other invasive procedure Subjects with uncontrolled hypertension (more than 140/90 mmHg), diabetes mellitus (RBS more than 200 mg/dl), and other systemic illness Subject with Serum PSA more than 4ng/ml.
结局指标
主要结局
Improvement in IPSS Score
时间窗: 0th, 15th, 30th and 45th days
次要结局
- Prostate size reduction as visualized in USG(Reduction in PVR (Pre and Post))
研究者
Dr Ruchir Kumar
National Institute of Unani Medicine
研究点 (1)
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