CTRI/2025/06/089465尚未招募不适用
A randomized, double-blind, placebo-controlled pilot study to evaluate the efficacy of LN18178 on improving sperm virility (Sperm motility, sperm concentration, and sperm morphology)
Gencor Lifestage Solutions2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年6月30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
- 40
- 试验地点
- 2
- 主要终点
- Sperm motility (%)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of LN18178 on improving sperm virility. A total of 40 Males aged between 25-45 years will be included in the study. Assessment of inclusion and exclusion criteria will be done based on clinical and laboratory investigations. The eligible subjects will be randomized as per the computer-generated randomization list. The subjects will be assigned to either LN18178 - 400 mg or placebo arms at 1:1 ratio. The subjects will be instructed to take one capsule daily in the morning after breakfast for 12 weeks.
A part from primary and secondary outcomes, the study will also record the vital signs and adverse events to evaluate the herbal composition safety and tolerability. The safety assessment of the LN18178 will also include routine laboratory investigations on blood, urine and clinical chemistry at screening and the final visit of the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 25.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Male
入选标准
- •1.Males aged between 25-45 years with a Body Mass Index (BMI) of 20-29 kg/m
- •2.Subjects with a history of infertility of at least 12 months despite regular unprotected intercourse.
- •3.Subjects with semen analysis showing abnormal sperm concentration (less than 16 million/ml), progressive motility (less than 30%), and total motility (less than 42%), normal morphology (less than 4%).
- •(WHO guidelines- 6th edition, 2021) 4.Subjects with total testosterone greater than or equal to 300 ng/dL.
- •5.Subjects who are willing to abstain from sexual activity that results in ejaculation for 3 to 5 days before semen analysis.
- •6.Subjects who are in a stable sexual relationship and sexually active during the study.
- •7.Subjects willing to use contraceptives during study period.
- •9.No urogenital infection or anatomical abnormality of this system, including varicocele; no prior history of surgery in the pelvic area; no uncontrolled systemic illness, such as liver and gallbladder cancers, renal failure, thyroid disorders, and cerebral haemorrhage; no prior history of trauma to the testes; no unilateral testicular atrophy; no previous history of chemotherapy or treatment with anticoagulants, corticosteroids, testosterone and anti-androgen medications during the 8 weeks before the study.
- •10.Subject considered generally healthy as per health history and routine clinical investigations during screening.
- •11.Ability to understand the risks/benefits of the protocol and willing to sign the written informed consent.
排除标准
- •1.Employees working on night shifts.
- •2.Subjects with identifiable cause for Oligoasthenoteratozoospermia (OAT) (includes Cryptorchidism, Orchitis and Radiation or chemotherapy etc.).
- •3.Subjects with Systolic greater than 140 and Diastolic greater than 90 mmHg blood pressure and Fasting blood glucose (FBG) greater than 125 mg/dl.
- •4.Smokers and alcoholics.
- •5.Subjects underwent treatment for COVID 19 within the last 3 months or tested positive during the study will be excluded.
- •6.Subject with any physical disability that may limit sexual function.
- •7.Subjects with history of taking medications for oligospermia or any other sexual problems, including PDE-5 inhibitors, and dysfunctions related to genito-urinary system, muscular dystrophy and coagulation.
- •8.Subjects with clinical history of genital surgery, endocrine disorders e.g. hypopituitarism, pituitary tumors, hypo- and hyperthyroidism, hypogonadism, inherited (genetic and chromosomal) disorders, etc.
- •9.Subjects diagnosed with sleep apnea or related disorders.
- •10.Subjects consuming medications that can interfere with muscle mass such as corticosteroids, testosterone replacement or anabolic drugs.
- •11.Subjects who consume recreational drugs (such as cocaine, methamphetamine, marijuana, etc.) or chewable tobacco products.
- •12.Subjects having history of Benign Prostate Hyperplasia (BPH), stroke, myocardial infarction, coronary artery disease, cardiac failure, angina, life-threatening arrhythmia within the past 6 months.
- •13.Subjects under medications including vitamins, antidepressants, anticholinergics, inhaled beta agonists, anti-hyperlipidemics, psychotropics etc.
- •15.Subjects who underwent major surgical procedures in last 6 months, which may affect their quality of life.
- •16.Subject with HIV positive or any other STDs. 17.History of psychiatric disorder that may impair the ability of subjects to provide written informed consent.
- •18.Subject has participated in a clinical study within the last 90 days prior to recruitment or concurrently participating in another study.
结局指标
主要结局
Sperm motility (%)
时间窗: Screening, weeks 8, 12 & 16
Change from baseline to the end of the study period in :
时间窗: Screening, weeks 8, 12 & 16
次要结局
- Change from baseline to the end of the study period in :(Semen analysis (concentration and morphology of sperm))
- Sperm DNA fragmentation Index(Screening, Weeks 12 & 16)
- International Index of Erectile Function (IIEF-15)(Baseline (day 1), Weeks 4, 8, 12 & 16)
- Quality of life short form (SF-36)(Baseline (day 1), Weeks 4, 8, 12 & 16)
- Serum hormonal biomarkers: total and free testosterone, LH, FSH and Inhibin B(Baseline (day 1), Weeks 12 & 16)
- Semen oxidative stress markers (MDA, GSH and TAC)(Baseline (day 1), Weeks 12 & 16)
- Semen inflammation markers (IL-6 and TNF-alpha)(Baseline (day 1), Weeks 12 & 16)
研究者
研究点 (2)
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