CTRI/2024/06/068939尚未招募不适用
A Prospective Interventional Open label Single-centre Single arm Study to Evaluate the Efficacy and Safety of CoQ10 Capsules in Subject suffering with Oligospermia
M/s Synthite Industries Private Limited1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年6月26日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- 1 Percent change in sperm count/concentration sperm motility from
研究概览
简要总结
The study is designed as Prospective, Interventional, Open label, Single-centre, Single arm. Participants enrolled in this prospective, interventional, open-label, single-center, single-arm study will receive the CoQ10 Capsule along with defined SoC, a formulation comprising all-natural Coenzyme Q10. The treatment regimen is designed to assess the safety and efficacy of this capsule in individuals experiencing low sperm count and quality. The treatment duration will be 3 months, with each participant taking 2 capsules a day (after breakfast and after dinner). Various parameters will be assessed including Quality of Life questionnaires, Hematology, Biochemistry, and Liver function. Adverse Events (AE) and Serious Adverse Events (SAE) will be monitored and documented throughout the study duration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- Male
入选标准
- •1 Male participants aged 18 to 50 years 2 Diagnosis of oligospermia, confirmed by semen analysis showing a sperm concentration of less than 15 million sperm per milliliter or through medical history of the subjects 3 Willingness to provide informed consent to participate in the study 4 Ability to comply with the study protocol including attending study visits and completing study-related assessments.
- •5 Stable sexual partner or intention to engage in heterosexual intercourse for the duration of the study 6 Willingness to refrain from using other fertility treatments or supplements during the study period 7 Adequate understanding of the study procedures and willingness to follow the investigators instructions.
排除标准
- •History and drug alcohol abuse smoking
- •BMI greater than 30 kg per m2
- •History of cancer chemotherapy
- •History of significant medical conditions that could affect fertility or interfere with study participation including severe cardiovascular disease uncontrolled hypertension renal failure liver disease or malignancy
- •Contraindication for the use of CoQ10
- •Genital disease (cryptorchidism current genital inflammation or varicocele)
- •Known history of human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS) related illness and or known history of Hepatitis B virus (HBV) defined by presence of hepatitis B surface antigen (HBsAg) and or known history of Hepatitis C virus (HCV) defined by presence of hepatitis C antibody (HCVAb)
- •Genital trauma or surgery to the reproductive system
- •Hepatobiliary disease
- •Significant renal insufficiency
- •Occupational exposures to reproductive toxins
- •Endocrine abnormality
- •Recent or current sexually transmitted infection
- •Use of cytotoxic drugs
- •Use of immunosuppressants
- •Clinically relevant systemic disease (e g Insulin dependent diabetes adrenal dysfunction organic intracranial lesion, or hypothalamic tumor) or serious illness (Neoplasia)
- •Daunorubicin, Doxorubicin, Blood Pressure Medications Warfarin Timolol atorvastatin cerivastatin lovastatin pravastatin simvastatin gemfibrozil tricyclic antidepressant medications (including amitriptyline amoxapine clomipramine desipramine doxepin imipramine nortriptyline protriptyline and trimipramine) multivitamins or any vitamin supplementation except Folic acid 18.Use of anticonvulsants 19.Use of androgens or antiandrogens 20.History of central nervous system injury 21.Neurological or psychiatric disease to potentially compromise study data collection.
- •22.Abnormal COH screening blood done for both partners, including prolactin thyroid stimulating hormone prior to participation in study 23Treatment of erectile dysfunction with any drugs during the past 4 weeks 24 Current supplementation with ingredients being tested unless 1month washout period.
结局指标
主要结局
1 Percent change in sperm count/concentration sperm motility from
时间窗: 1 Screening to EOT at week 12
次要结局
- 1 Change in Hormonal Levels(2 Improvement in Total IIEF-EF score)
研究者
Dr Shubhangi Shahare
Eras Bharti Hospital
研究点 (1)
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