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Effect of Herbal Supplement on Improving Sperm Virility | Clinical Trials | Clareo Health

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Effect of Herbal Supplement on Improving Sperm Virility

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)

NCT07109622•GENCOR Lifestage Solutions

View on ClinicalTrials.gov

Summary

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

Detailed Description

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.

Eligibility

Age

25 - 45 years

Sex

MALE

Healthy Volunteers

Yes

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.
+1 more criteria

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.
+8 more criteria

Key Dates

Start Date

August 8, 2025

Primary Completion Date

February 10, 2026

Completion Date

February 10, 2026

Last Updated

August 7, 2025

Enrollment

ESTIMATED participants

Conditions

Healthy Human Volunteers

Interventions

LN18178

DIETARY_SUPPLEMENT

Placebo

DIETARY_SUPPLEMENT

Contacts

Mr Machiraju Garga

CONTACT

+91 8331015019 machiraju.gls@gmail.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 7, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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