An Open-Label Randomized Controlled Trial to Compare the Clinical Efficacy and Safety of Alpha Blocker Versus Alpha Blocker + Melatonin 3 mg in the Treatment of Men Having Nocturia Associated with Benign Prostatic Hyperplasia

Fourrts (India) Laboratories Pvt.Limited1 个研究点分布在 1 个国家目标入组 60 人开始时间: 2024年10月14日最近更新: 2024年9月27日

试验速览

阶段: 3 期
状态: 尚未招募
发起方
入组人数: 60
试验地点: 1
主要终点: 1. Change in the number of nocturnal voids per night from baseline to 12 weeks post study

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study aims to evaluate the efficacy and safety of an alpha blocker alone compared to an alpha blocker combined with melatonin in treating nocturia associated with Benign Prostatic Hyperplasia (BPH).

Inclusion Criteria:

Participants must be 50 years or older.
Must have nocturia with at least two nocturnal voids per night, with each episode preceded and followed by sleep.
International Prostate Symptom Score (IPSS) greater than 7.
Nocturia symptoms present for at least one month prior to enrollment.
Diagnosis of Benign Prostatic Hyperplasia (BPH) based on medical history.
Ability and willingness to provide written informed consent.

Exclusion Criteria:

Known structural problems or anomalies of the urinary tract, or recent pharmacological interventions for nocturia (including melatonin).
Presence of stress or urge incontinence, or a history of urinary tract infections.
Allergy, hypersensitivity, or contraindications to melatonin, or significant health conditions like uncontrolled diabetes or malignancies.
Use of medications affecting urination or sleep, regular smoking, alcohol abuse, or participation in another clinical trial within the past 30 days.

Sixty men meeting the eligibility criteria will be randomly assigned to two groups:

Group 1: Alpha blocker (Tamsulosin 0.4 mg or Silodosin 8 mg)
Group 2: Alpha blocker plus melatonin (3 mg).

Participants will take their assigned medication orally before bedtime for 12 weeks and maintain a bladder diary to record nocturia episodes.
Primary outcomes include

changes in the number of nocturnal voids,
International Prostate Symptom Score (IPSS),
urination frequency, and Quality of Life (SF-12).

Safety will be assessed by monitoring adverse events and conducting laboratory tests

Complete Blood Count,
Random Blood Sugar,
HbA1c,
Renal Function Test, and
Liver Function Test).

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 80.00 Year(s)（—）
性别: Male

入选标准

•Age 50 years or older
•Clinical diagnosis of nocturia, defined as at least 2 nocturia episodes per night, with each episode preceded and followed by sleep
•International Prostate Symptom Score (IPSS) greater than 7
•Nocturia symptoms present for a minimum of one month prior to enrollment
•Willingness and ability to provide written informed consent.

排除标准

•Known structural problems or embryological anomalies of the urinary tract (including urethral stenosis)
•Pharmacological intervention for nocturia (including melatonin) within one month preceding enrollment
•Presence of stress or urge incontinence History of urinary tract infections (based on medical records)
•Known allergy, hypersensitivity, proven inefficiency, or contraindications to melatonin or its excipients
•History of cardiopulmonary or cerebral diseases, hepatic or renal dysfunction, or hypertension HbA1c greater than eight percent
•Uncontrolled diabetes mellitus, diabetes insipidus, or clinically significant microalbuminuria
•History of malignancy (including prostate cancer), chemotherapy, or radiotherapy
•Use of medications that might cause disturbances in urination or sleep (such as diuretics, tranquilizers, or hypnotics)
•Use of corticosteroids, sleeping pills, or antidepressants
•Use of medications that interact with the pharmacokinetics of melatonin (such as carbamazepine, quinolones, rifampicin, cimetidine, or estrogen) within one month preceding enrollment Regular cigarette smoking (at least one per day or equivalent)
•Alcohol abuse (more than four drinks on any day or more than fourteen drinks per week)
•Autoimmune disease or use of immunosuppressive drugs
•Rare hereditary conditions such as galactose/lactose intolerance or galactose malabsorption
•History of Rapid Eye Movement (REM) sleep disorder
•Neurological or psychological abnormalities Participation in another clinical trial within the past thirty days
•Any other condition(s) that, in the opinion of the Investigator, would make the patient unsuitable for the study.