NCT07816172尚未招募2 期
A Randomised, Double-blind, Placebo-controlled Trial to Evaluate the Effects of Macanity on Urinary Health in Males Experiencing Lower Urinary Tract Symptoms
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Change from baseline to the end of the study period in IPSS
研究概览
简要总结
The goal of this study is to evaluate the effects of Macanity on urinary health in males experiencing LUTS. Males aged over 40 years of age who experience LUTS will be recruited and assigned to a study treatment which they will take for 12 weeks. They will have 3 remote visits over 12 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Adult males > 40 years of age experiencing LUTS
- •Generally healthy
- •BMI 18-32 kg/m2
- •Moderate International Prostate Symptom Score (IPSS) score: 8-
- •IPSS quality of life (QoL) score >3
- •Able to provide informed consent
- •Agree to not participate in another clinical trial while enrolled in this trial
排除标准
- •Have a serious illness e.g. mood disorders such as depression or bipolar disorder, anxiety, neurological disorders such as MS, kidney disease, liver disease, heart conditions, hypertension
- •Have an unstable illness e.g. diabetes and thyroid gland dysfunction, uncontrolled hypertension with diastolic blood pressure > 100 mmHg
- •Prostate specific antigen (PSA) testing > 2 years ago
- •Have used a drug/supplement for benign prostatic hyperplasia (BPH) or other urological symptoms within the last 30 days
- •Have had a urinary infection in the last 30 days or have, chronic urinary tract infections, or diagnosed chronic prostatitis
- •Have had urogenital surgery within the last 6 months
- •Have had bladder biopsy and/or cystoscopy and biopsy within the past 30 days.
- •Have been diagnosed with chronic persistent local pathology (e.g. interstitial cystitis, bladder stones)
- •Current malignancy including prostatic cancer (excluding Basal Cell Carcinoma) or chemotherapy or radiotherapy treatment for malignancy within the previous 2 years
- •Currently taking Coumadin (Warfarin), Heparin, Dalteparin, Enoxaparin or other anticoagulation therapy including low dose aspirin; antihypertensive medications, tetracyclic antidepressants, thyroid medications
- •Active smokers, nicotine use or drug (prescription or illegal substances) abuse
- •Chronic past and/or current alcohol use (>21 alcoholic drinks per week)
- •Allergic to any of the ingredients in active or placebo formula, or an allergy to cruciferous vegetables
- •Participants who are currently participating in any other clinical trial or who have participated in any other clinical trial during the past 1 month
- •Any condition which in the opinion of the investigator makes the participant unsuitable for inclusion
研究组 & 干预措施
Macanity
Experimental
Participants will take 2 capsules containing Macanity each day for 12 weeks
干预措施: Maca Root (Dietary Supplement)
Placebo
Placebo Comparator
Participants will take 2 capsules containing placebo each day for 12 weeks
干预措施: Placebo (Other)
结局指标
主要结局
Change from baseline to the end of the study period in IPSS
时间窗: Baseline to 12 weeks
Change from baseline to the end of the study period in overall IPSS score, IPSS QoL score and individual IPSS items between baseline and each assessment time.
次要结局
- Change from baseline to the end of the study period in urinary symptoms and their effect on QoL(Baseline to 12 weeks)
- Change from baseline to the end of the study period in overall improvement via the PGI-C(week 6 and week 12)
- Change from baseline to the end of the study period in Self-Assessment Questionnaire(Week 6, week 12)
- Change from baseline to the end of the study period in Safety via AE monitoring(Baseline to 12 weeks)
研究者
研究点 (1)
Loading locations...
相似试验
尚未招募
不适用
To see which of the two nasal treatments works better in frozen shoulderCTRI/2026/03/106439Dr Padmaja P Deshpande280
尚未招募
2/3 期
A Randomized Controlled Clinical Study to Evaluate the Efficacy of Hinguvachadi tablet and tablet Mefanamic acid and Dicylomine in the management of painful menstruation.CTRI/2024/11/076238Tilak Ayurveda Mahavidyalaya60
尚未招募
不适用
To evaluate the proper emetic symptoms of Madanaphala varti against conventionally used emetic drug in AcneCTRI/2024/10/075152Vaidyaratnam PS Varier Ayurveda College26
尚未招募
2/3 期
A Clinical Trial to study the effects of two therapies, Marmachikitsa and Agnikarma in the management of Tennis Elbow.CTRI/2024/06/068671Dr Nirmala Chandrabhanji Apaturkar128
尚未招募
2/3 期
Study to assess the efficacy of Jatipatradi kwath gandusha in management of Pittaj Mukhapaka with special Reference to Aphthous StomatitisCTRI/2024/10/074734Dr Vrushali Eknath Tandale120