Clinical study to evaluate efficacy and safety of Beehj tablets in participants suffering from male infertility – An open-label, single-arm, multi-centric, non-comparative, interventional, prospective study
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 8
- 主要终点
- Changes in sperm count and motility
研究概览
简要总结
It is a clinical study to evaluate efficacy and safety of Beehj tablets in participants suffering from male infertility. The study will be conducted at 8 to 10 centers in India. The primary objective of the study will be to assess change in sperm count and motility. The secondary objectives of the study will be to assess changes in sperm morphology, erectile function, sexual desire, energy levels, premature ejaculation, changes in hormonal regulation of spermatogenesis, spontaneous achieved pregnancies, adverse events and vitals and laboratory investigations on Screening Visit (Up to 5 days), Baseline visit (Day 0), Visit 1, (Day 30), Visit 2 (Day 60), Visit 3 (Day 90), Visit 4 (Day 120)
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
- 21.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Male
入选标准
- •Sperm concentration less than 16 million per ml as per WHO Laboratory Manual for the Examination and Processing of Human Semen, Sixth Edition, 2021, 13, with or without normal sperm morphology, with or without normal total motility.
- •Subjects willing to give specimen of semen, ready to observe abstinence as per requirement of protocol, and willing to provide informed consent.
排除标准
- •Subjects having azoospermia, or aspermia, or necrospermia.
- •Subjects with clinical diagnosis of Varicocele & Hydrocele (If required USG with color doppler of testes will be done to confirm the diagnosis)
- •Subjects with history of undescended testis.
- •Subjects with inguinal hernia or other clinical condition on physical examination which may have relation to low sperm count
- •Subjects with accessory gland infection
- •Known cases of Diabetes Mellitus Type 2 (DM2), Uncontrolled Hypertension (HTN), Uncontrolled Thyroid dysfunction, chronic kidney disease (CKD), Liver Cirrhosis, Cardiac Ailments, psychological disorders currently on medication, epilepsy (convulsions), STDs including HIV and Hepatitis B
- •Presence of pus cells in semen (Pyospermia), absence of fructose in semen and Semen liquefaction time greater than 30 minutes, history of testicular or scrotal tumours, cysts, or obstruction
- •Subjects with severe form of sexual dysfunction and history of presence of significant alcoholism or drug abuse within the past 1 year and significant smoking (more than 10 cigarettes per day) or consumption of tobacco/nicotine products more than 10 times per day.
- •Subjects who underwent surgery within last 4 weeks or planned major surgery within next 120 days from the date of screening and subjects who have participated in any drug research study within past 3 months.
- •History of allergic reaction to any of the drug component.
- •Other conditions, which in the opinion of the investigators, makes the patient unsuitable for enrolment or could interfere with his participation in, and completion of the protocol.
结局指标
主要结局
Changes in sperm count and motility
时间窗: Screening Visit (Up to 5 days), Baseline visit (Day 0), Visit 1, (Day 30), Visit 2 (Day 60), Visit 3 (Day 90), Visit 4 (Day 120)
次要结局
- 1. Changes in sperm morphology, erectile function, sexual desire, energy levels(2. Assessment of premature ejaculation)
研究者
Dr Satish R Khatal
Bharati Vidyapeeth Deemed to Be University, College of Ayurved and Hospital.