Effect of Herbal Supplement on Improving Sperm Virility

N/ANot Yet RecruitingNCT07109622

GENCOR Lifestage Solutions40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

DOUBLE

Enrollment

Conditions

Healthy Human Volunteers

Interventions

LN18178DIETARY_SUPPLEMENT

400 mg, One capsule to be consumed in the morning after breakfast for 12 weeks.

PlaceboDIETARY_SUPPLEMENT

One capsule to be consumed in the morning after breakfast for 12 Weeks

Eligibility

Sex: MALEMin age: 25 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Males aged between 25-45 years with a Body Mass Index (BMI) of 20-29 kg/m2. 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 (\< 16 million/ml), progressive motility (\< 30%), and total motility (\< 42%), normal morphology (\< 4%). (WHO guidelines- 6th edition, 2021) 4. Subjects with total testosterone ≥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. 8. Subjects agree to maintain current diet and activity level. 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. Exclusion Criteria: 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 \>140 and Diastolic \>90 mmHg blood pressure and Fasting blood glucose (FBG) \>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- hyperlipidemic, psychotropics etc. 14. Subjects using any centrally acting anorectic agents, drugs that inhibit the absorption of nutrients and endocannabinoid neuromodulators during the two weeks prior to enrolment into the study. 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.

Outcomes

Primary Outcomes

Change in motility (% Motile Sperms) using manual microscopic examination.

Assessed through manual microscopic examination according to WHO guidelines. The percentage of motile sperm (progressive + non-progressive) will be calculated. A higher percentage reflects improved reproductive function.

Time frame: Screening, weeks 8, 12 & 16

Secondary Outcomes

Change in semen Concentration (millions/mL) using manual microscopic examination.

Measured manually using a Makler counting chamber. Concentration is expressed in millions of sperm per milliliter. Higher concentration indicates better fertility potential.

Time frame: Screening, weeks 8, 12 & 16

Change from baseline to the end of the study period in Morphology of sperm (% normal forms) using manual microscopic examination.

Assessed through microscopic evaluation following WHO criteria. The percentage of sperm with normal morphology will be reported. Greater % indicates enhanced fertility potential.

Time frame: Screening, weeks 8, 12 & 16

Change from baseline to the end of the study period in Sperm DNA fragmentation Index (% DFI) using Sperm Chromatin Dispersion method.

Assessed using the SCD (Sperm Chromatin Dispersion) method. The DNA Fragmentation Index (DFI) represents the percentage of sperm with fragmented DNA. A decrease in DFI is associated with improved fertilization potential.

Time frame: Screening, Weeks 12 & 16

Change from baseline to the end of the study period in International Index of Erectile Function (IIEF-15)

A validated, self-administered questionnaire consisting of 15 items covering erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction. Each item scored from 0 to 5; total score ranges from 0 to 75. Higher scores indicate better sexual function.

Central Contacts

Mr Machiraju Garga

CONTACT

+91 8331015019 machiraju.gls@gmail.com

Data from ClinicalTrials.gov

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