Effect of Herbal Supplement on Improving Sperm Virility

NCT07109622 | Not Yet Recruiting

• 1 other identifier: GNC/SV/LN18178/25
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate the efficacy of LN18178 on improving sperm virility.

Conditions

Healthy Human Volunteers

Keywords

Sperm Virility

Outcome Measures

Primary Outcomes (1)

• 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.

  Screening, weeks 8, 12 & 16

Secondary Outcomes (15)

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

  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.

  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.

  Screening, Weeks 12 & 16

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

  Baseline (day 1), Weeks 4, 8,12 & 16

• Change from baseline to the end of the study period in Quality of life short form (SF-36)

  Baseline (day 1), Weeks 4, 8,12 & 16

Study Arms (2)

LN18178

EXPERIMENTAL

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

Dietary Supplement: LN18178

Placebo

OTHER

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

Dietary Supplement: Placebo

Interventions

LN18178 DIETARY_SUPPLEMENT

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

LN18178

Placebo DIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

• Age: 25 Years - 45 Years
• Gender Eligibility Details: Males aged between 25-45 years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Males aged between 25-45 years with a Body Mass Index (BMI) of 20-29 kg/m2.
• Subjects with a history of infertility of at least 12 months despite regular unprotected intercourse.
• 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)
• Subjects with total testosterone ≥300 ng/dL.
• Subjects who are willing to abstain from sexual activity that results in ejaculation for 3 to 5 days before semen analysis.
• Subjects who are in a stable sexual relationship and sexually active during the study.
• Subjects willing to use contraceptives during study period.
• Subjects agree to maintain current diet and activity level.
• 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.
• Subject considered generally healthy as per health history and routine clinical investigations during screening.
• Ability to understand the risks/benefits of the protocol and willing to sign the written informed consent.

You may not qualify if:

• Employees working on night shifts.
• Subjects with identifiable cause for Oligoasthenoteratozoospermia (OAT) (includes Cryptorchidism, Orchitis and Radiation or chemotherapy etc.).
• Subjects with Systolic \>140 and Diastolic \>90 mmHg blood pressure and Fasting blood glucose (FBG) \>125 mg/dl.
• Smokers and alcoholics.
• Subjects underwent treatment for COVID 19 within the last 3 months or tested positive during the study will be excluded.
• Subject with any physical disability that may limit sexual function.
• 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.
• Subjects with clinical history of genital surgery, endocrine disorders e.g. hypopituitarism, pituitary tumors, hypo- and hyperthyroidism, hypogonadism, inherited (genetic and chromosomal) disorders, etc.
• Subjects diagnosed with sleep apnea or related disorders.
• Subjects consuming medications that can interfere with muscle mass such as corticosteroids, testosterone replacement or anabolic drugs.
• Subjects who consume recreational drugs (such as cocaine, methamphetamine, marijuana, etc.) or chewable tobacco products.
• 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.
• Subjects under medications including vitamins, antidepressants, anticholinergics, inhaled beta agonists, anti- hyperlipidemic, psychotropics etc.
• 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.
• Subjects who underwent major surgical procedures in last 6 months, which may affect their quality of life.

Sponsors & Collaborators

• GENCOR Lifestage Solutions: lead

Related Publications (16)

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Central Study Contacts

Mr Machiraju Garga

CONTACT

+91 8331015019; machiraju.gls@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2025
• First Posted: August 7, 2025
• Study Start: August 8, 2025
• Primary Completion: February 10, 2026
• Study Completion: February 10, 2026
• Last Updated: August 7, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share