Healthy Human VolunteersNCT07109622
Effect of Herbal Supplement on Improving Sperm Virility
A study testing LN18178 in people with Healthy Human Volunteers, run by GENCOR Lifestage Solutions.
Trial summary
The purpose of this study is to evaluate the efficacy of LN18178 on improving sperm virility. Read more about this study
- Who is it for?
- Ages 25 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Human Volunteers
- What is being tested?
- LN18178
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 8 Aug 2025to 10 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
- Subject with HIV positive or any other STDs.
- History of psychiatric disorder that may impair the ability of subjects to provide written informed consent.
- Subject has participated in a clinical study within the last 90 days prior to recruitment or concurrently participating in another study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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)
The purpose of this study is to evaluate the efficacy of LN18178 on improving sperm virility.
Read the 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.
- Conditions
- Healthy Human Volunteers
- Being tested
- LN18178, Placebo
- Keywords
- Sperm Virility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| LN18178 | Experimental | 400 mg, One capsule to be consumed in the morning after breakfast for 12 weeks. Receives: Dietary Supplement: LN18178 |
| Placebo | Other | One capsule to be consumed in the morning after breakfast for 12 Weeks Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Screening, weeks 8, 12 & 16
Secondary outcomes (15)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
The 36-Item Short Form (SF-36) is a self-reported questionnaire used to assess overall health and quality of life. It consists of 8 domains, each scored on a scale from 0 to 100. Higher scores indicate a better quality of life and improved health status.
Measured: Baseline (day 1), Weeks 4, 8,12 & 16
Change from baseline to the end of the study period in Serum hormonal biomarkers: Total Testosterone (ng/mL) using Enzyme-Linked Immunosorbent Assay method
Testosterone is a male sex hormone produced by the gonadal tissue. An increase in both total testosterone levels enhances sexual drive and supports sperm production
Measured: Baseline (day 1), Weeks 12 &16
Change from baseline to the end of the study period in Serum hormonal biomarkers: Free Testosterone (pg/mL) using Enzyme-Linked Immunosorbent Assay method
Testosterone is a male sex hormone produced by the gonadal tissue. An increase in both free testosterone levels enhances sexual drive and supports sperm production
Measured: Baseline (day 1), Weeks 12 &16
Change from baseline to the end of the study period in Serum hormonal biomarkers: Follicle-Stimulating Hormone (mIU/mL) using Enzyme-Linked Immunosorbent Assay method
Follicle-stimulating hormone (FSH), produced by the pituitary gland, plays a key role in supporting spermatogenesis. Any deviation from normal FSH levels can disrupt sperm production and affect sexual development.
Measured: Baseline (day 1), Weeks 12 &16
Change from baseline to the end of the study period in Serum hormonal biomarkers: Luteinizing Hormone (mIU/mL) using Enzyme-Linked Immunosorbent Assay method
Luteinizing hormone (LH), released by the pituitary gland, stimulates testosterone production. Maintenance LH levels within the normal range is important for healthy sexual function.
Measured: Baseline (day 1), Weeks 12 &16
Change from baseline to the end of the study period in Serum hormonal biomarkers: Inhibin B (pg/ml) using Enzyme-Linked Immunosorbent Assay method
Inhibin B is produced exclusively by the testes and plays a key role in regulating FSH secretion from the pituitary gland. Improvement in Inhibin B is an indication of healthy testicular volume and an adequate sperm count.
Measured: Baseline (day 1), Weeks 12 &16
Change from baseline to the end of the study period in Semen oxidative stress markers MDA: Malondialdehyde (ng/mL) using Enzyme-Linked Immunosorbent Assay method
MDA, an end product of lipid peroxidation. High lipid peroxidation as represented by MDA levels may cause changes in the sperm and diminish fertility. It is reported that the high MDA production in the male with low fertilization rates. Reduction of MDA by using antioxidant therapy was correlated with the improvement of fertilization rates. A decrease high MDA level of semen favours spermatogenesis.
Measured: Baseline (day 1), Weeks 12 &16
Change from baseline to the end of the study period in Semen inflammation markers IL-6: Interleukin 6 (pg/mL) using Enzyme-Linked Immunosorbent Assay method
IL-6 is a pro-inflammatory cytokine and high levels of IL-6 in seminal plasma are often linked to decreased sperm motility. Increased IL-6 levels in seminal plasma indicate inflammation in male reproductive tract, that affects sperm quality.
Measured: Baseline (day 1), Weeks 12 &16
Change from baseline to the end of the study period in Semen oxidative stress markers GSH: Glutathione (µM) using Enzyme-Linked Immunosorbent Assay method
GSH is a powerful antioxidant that neutralizes harmful free radicals (reactive oxygen species or ROS) within sperm cells. GSH helps maintain the integrity of sperm membranes, including the plasma membrane, which is essential for sperm motility and fertilization. Sperm motility is positively correlated with seminal reduced glutathione (GSH) levels. GSH deficiency has been shown to lead to the instability of the spermatozoa midpiece, thus resulting in defective motility and morphology of the spermatozoa.
Measured: Baseline (day 1), Weeks 12 &16
Change from baseline to the end of the study period in Semen oxidative stress markers TAC: Total Antioxidant Capacity (mM) using Enzyme-Linked Immunosorbent Assay method
Low seminal plasma antioxidants have been found to be implicated in reducing sperm concentration, motility and morphology. Total antioxidant capacity (TAC) has shown to be strongly correlated with semen quality and male infertility.
Measured: Baseline (day 1), Weeks 12 &16
Change from baseline to the end of the study period in Semen inflammation markers TNF-alpha: Tumor Necrosis Factor-Alpha (pg/mL) using Enzyme-Linked Immunosorbent Assay method
TNF-alpha, a cytokine involved in inflammation, can negatively impact sperm quality. Studies indicate that elevated TNF-alpha levels in seminal fluid are associated with reduced sperm motility, viability, and increased DNA damage. TNF-alpha can trigger programmed cell death (apoptosis) in sperm cells, leading to a reduction in sperm count.
Measured: Baseline (day 1), Weeks 12 &16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2025
- Study start8 Aug 2025 (estimated)
- Primary completion10 Feb 2026 (estimated)
- Study completion10 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Healthy Human VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GENCOR Lifestage Solutions
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07109622
- Sponsor's protocol ID
- GNC/SV/LN18178/25
- Status last verified
- Jul 2025
- First submitted
- 16 Jul 2025
- Last updated
- 7 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abbasi B, Molavi N, Tavalaee M, Abbasi H, Nasr-Esfahani MH. Alpha-lipoic acid improves sperm motility in infertile men after varicocelectomy: a triple-blind randomized controlled trial. Reprod Biomed Online. 2020 Dec;41(6):1084-1091. doi: 10.1016/j.rbmo.2020.08.013. Epub 2020 Aug 20.
PubMed 33032908Shabsigh R, Kaufman JM, Steidle C, Padma-Nathan H. Randomized study of testosterone gel as adjunctive therapy to sildenafil in hypogonadal men with erectile dysfunction who do not respond to sildenafil alone. J Urol. 2004 Aug;172(2):658-63. doi: 10.1097/01.ju.0000132389.97804.d7.
PubMed 15247755Pandit S, Biswas S, Jana U, De RK, Mukhopadhyay SC, Biswas TK. Clinical evaluation of purified Shilajit on testosterone levels in healthy volunteers. Andrologia. 2016 Jun;48(5):570-5. doi: 10.1111/and.12482. Epub 2015 Sep 22.
PubMed 26395129Yoon HS, Kim JR, Park GY, Kim JE, Lee DH, Lee KW, Chung JH. Cocoa Flavanol Supplementation Influences Skin Conditions of Photo-Aged Women: A 24-Week Double-Blind, Randomized, Controlled Trial. J Nutr. 2016 Jan;146(1):46-50. doi: 10.3945/jn.115.217711. Epub 2015 Nov 18.
PubMed 26581682Wang-Polagruto JF, Villablanca AC, Polagruto JA, Lee L, Holt RR, Schrader HR, Ensunsa JL, Steinberg FM, Schmitz HH, Keen CL. Chronic consumption of flavanol-rich cocoa improves endothelial function and decreases vascular cell adhesion molecule in hypercholesterolemic postmenopausal women. J Cardiovasc Pharmacol. 2006;47 Suppl 2:S177-86; discussion S206-9. doi: 10.1097/00005344-200606001-00013.
PubMed 16794456Forest CP, Padma-Nathan H, Liker HR. Efficacy and safety of pomegranate juice on improvement of erectile dysfunction in male patients with mild to moderate erectile dysfunction: a randomized, placebo-controlled, double-blind, crossover study. Int J Impot Res. 2007 Nov-Dec;19(6):564-7. doi: 10.1038/sj.ijir.3901570. Epub 2007 Jun 14.
PubMed 17568759Srivastava MK, Singh G, Kodur RR, Yalamanchi A. A Combination of Punica granatum Fruit Rind and Theobroma cacao Seed Extracts Enhances Sexual Function in Aging Males in a Randomized, Double-blind, Placebo-controlled Study. Int J Med Sci. 2025 Jan 1;22(2):383-397. doi: 10.7150/ijms.99958. eCollection 2025.
PubMed 39781534Pandit SL, Yaligar D, Halemane M, Bhat A. A proprietary blend of standardized Punica granatum fruit rind and Theobroma cocoa seed extracts mitigates aging males' symptoms: A randomized, double-blind, placebo-controlled study. Int J Med Sci. 2022 Jul 11;19(8):1290-1299. doi: 10.7150/ijms.73645. eCollection 2022.
PubMed 35928723Sreeramaneni PGA, Yalamanchi A, Konda MR, Cherukuri SHV, Maroon JC. A Proprietary Herbal Blend Containing Extracts of Punica granatum Fruit Rind and Theobroma cocoa Seeds Increases Serum Testosterone Level in Healthy Young Males: A Randomized, Double-Blind Placebo-Controlled Study. J Diet Suppl. 2023;20(3):411-427. doi: 10.1080/19390211.2022.2035037. Epub 2022 Feb 6.
PubMed 35129040Madireddy RK, Alluri KV, Somepalli V, Golakoti T, Sengupta K. Toxicological Assessments of a Proprietary Blend of Punica granatum Fruit Rind and Theobroma cacao Seed Extracts: Acute, Subchronic, and Genetic Toxicity Studies. J Toxicol. 2022 May 6;2022:3903943. doi: 10.1155/2022/3903943. eCollection 2022.
PubMed 35571381Asiedu-Gyekye IJ, Frimpong-Manso S, N'guessan BB, Abdulai Seidu M, Osei-Prempeh P, Kwaku Boamah D. Macro- and Microelemental Composition and Toxicity of Unsweetened Natural Cocoa Powder in Sprague-Dawley Rats. J Toxicol. 2016;2016:4783829. doi: 10.1155/2016/4783829. Epub 2016 Aug 17.
PubMed 27610134Boroujeni SN, Malamiri FA, Bossaghzadeh F, Esmaeili A, Moudi E. The most important medicinal plants affecting sperm and testosterone production: a systematic review. JBRA Assist Reprod. 2022 Aug 4;26(3):522-530. doi: 10.5935/1518-0557.20210108.
PubMed 35234023Krausz C. Male infertility: pathogenesis and clinical diagnosis. Best Pract Res Clin Endocrinol Metab. 2011 Apr;25(2):271-85. doi: 10.1016/j.beem.2010.08.006.
PubMed 21397198Al Wattar BH, Rimmer MP, Teh JJ, Mackenzie SC, Ammar OF, Croucher C, Anastasiadis E, Gordon P, Pacey A, McEleny K, Sangster P. Pharmacological non-hormonal treatment options for male infertility: a systematic review and network meta-analysis. BMC Urol. 2024 Jul 29;24(1):158. doi: 10.1186/s12894-024-01545-1.
PubMed 39075435Jo J, Lee SH, Lee JM, Jerng UM. Semen Quality Improvement in a Man with Idiopathic Infertility Treated with Traditional Korean Medicine: A Case Report. Explore (NY). 2015 Jul-Aug;11(4):320-3. doi: 10.1016/j.explore.2015.04.007. Epub 2015 Apr 28.
PubMed 26025007
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07109622
- Acronym / sponsor ID
- GNC/SV/LN18178/25
- Conditions
- Healthy Human Volunteers
- Keywords
- Sperm Virility
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- GENCOR Lifestage SolutionsUniversity, hospital or other
- Study start
- 8 Aug 2025 (estimated)
- Primary completion
- 10 Feb 2026 (estimated)
- Study completion
- 10 Feb 2026 (estimated)
- First posted
- 7 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LN18178 | Experimental | Dietary Supplement: LN18178400 mg, One capsule to be consumed in the morning after breakfast for 12 weeks. |
| Placebo | Other | Dietary Supplement: PlaceboOne capsule to be consumed in the morning after breakfast for 12 Weeks |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LN18178400 mg, One capsule to be consumed in the morning after breakfast for 12 weeks. | Dietary supplement | LN18178 |
| PlaceboOne capsule to be consumed in the morning after breakfast for 12 Weeks | Dietary supplement | Placebo |
Primary outcome
Change in motility (% Motile Sperms) using manual microscopic examination.
Time frame: Screening, weeks 8, 12 & 16
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.
15 secondary outcomes
Change in semen Concentration (millions/mL) using manual microscopic examination.
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.
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.
Time frame: Screening, Weeks 12 & 16
Change from baseline to the end of the study period in International Index of Erectile Function (IIEF-15)
Time frame: 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)
Time frame: Baseline (day 1), Weeks 4, 8,12 & 16
Change from baseline to the end of the study period in Serum hormonal biomarkers: Total Testosterone (ng/mL) using Enzyme-Linked Immunosorbent Assay method
Time frame: Baseline (day 1), Weeks 12 &16
Change from baseline to the end of the study period in Serum hormonal biomarkers: Free Testosterone (pg/mL) using Enzyme-Linked Immunosorbent Assay method
Time frame: Baseline (day 1), Weeks 12 &16
Change from baseline to the end of the study period in Serum hormonal biomarkers: Follicle-Stimulating Hormone (mIU/mL) using Enzyme-Linked Immunosorbent Assay method
Time frame: Baseline (day 1), Weeks 12 &16
Change from baseline to the end of the study period in Serum hormonal biomarkers: Luteinizing Hormone (mIU/mL) using Enzyme-Linked Immunosorbent Assay method
Time frame: Baseline (day 1), Weeks 12 &16
Change from baseline to the end of the study period in Serum hormonal biomarkers: Inhibin B (pg/ml) using Enzyme-Linked Immunosorbent Assay method
Time frame: Baseline (day 1), Weeks 12 &16
Change from baseline to the end of the study period in Semen oxidative stress markers MDA: Malondialdehyde (ng/mL) using Enzyme-Linked Immunosorbent Assay method
Time frame: Baseline (day 1), Weeks 12 &16
Change from baseline to the end of the study period in Semen inflammation markers IL-6: Interleukin 6 (pg/mL) using Enzyme-Linked Immunosorbent Assay method
Time frame: Baseline (day 1), Weeks 12 &16
Change from baseline to the end of the study period in Semen oxidative stress markers GSH: Glutathione (µM) using Enzyme-Linked Immunosorbent Assay method
Time frame: Baseline (day 1), Weeks 12 &16
Change from baseline to the end of the study period in Semen oxidative stress markers TAC: Total Antioxidant Capacity (mM) using Enzyme-Linked Immunosorbent Assay method
Time frame: Baseline (day 1), Weeks 12 &16
Change from baseline to the end of the study period in Semen inflammation markers TNF-alpha: Tumor Necrosis Factor-Alpha (pg/mL) using Enzyme-Linked Immunosorbent Assay method
Time frame: Baseline (day 1), Weeks 12 &16
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2025.
- Background: PubMed 33032908Abbasi B, Molavi N, Tavalaee M, Abbasi H, Nasr-Esfahani MH. Alpha-lipoic acid improves sperm motility in infertile men after varicocelectomy: a triple-blind randomized controlled trial. Reprod Biomed Online. 2020 Dec;41(6):1084-1091. doi: 10.1016/j.rbmo.2020.08.013. Epub 2020 Aug 20.
- Background: PubMed 15247755Shabsigh R, Kaufman JM, Steidle C, Padma-Nathan H. Randomized study of testosterone gel as adjunctive therapy to sildenafil in hypogonadal men with erectile dysfunction who do not respond to sildenafil alone. J Urol. 2004 Aug;172(2):658-63. doi: 10.1097/01.ju.0000132389.97804.d7.
- Background: PubMed 26395129Pandit S, Biswas S, Jana U, De RK, Mukhopadhyay SC, Biswas TK. Clinical evaluation of purified Shilajit on testosterone levels in healthy volunteers. Andrologia. 2016 Jun;48(5):570-5. doi: 10.1111/and.12482. Epub 2015 Sep 22.
- Background: PubMed 26581682Yoon HS, Kim JR, Park GY, Kim JE, Lee DH, Lee KW, Chung JH. Cocoa Flavanol Supplementation Influences Skin Conditions of Photo-Aged Women: A 24-Week Double-Blind, Randomized, Controlled Trial. J Nutr. 2016 Jan;146(1):46-50. doi: 10.3945/jn.115.217711. Epub 2015 Nov 18.
- Background: PubMed 16794456Wang-Polagruto JF, Villablanca AC, Polagruto JA, Lee L, Holt RR, Schrader HR, Ensunsa JL, Steinberg FM, Schmitz HH, Keen CL. Chronic consumption of flavanol-rich cocoa improves endothelial function and decreases vascular cell adhesion molecule in hypercholesterolemic postmenopausal women. J Cardiovasc Pharmacol. 2006;47 Suppl 2:S177-86; discussion S206-9. doi: 10.1097/00005344-200606001-00013.
- Background: PubMed 17568759Forest CP, Padma-Nathan H, Liker HR. Efficacy and safety of pomegranate juice on improvement of erectile dysfunction in male patients with mild to moderate erectile dysfunction: a randomized, placebo-controlled, double-blind, crossover study. Int J Impot Res. 2007 Nov-Dec;19(6):564-7. doi: 10.1038/sj.ijir.3901570. Epub 2007 Jun 14.
- Background: PubMed 39781534Srivastava MK, Singh G, Kodur RR, Yalamanchi A. A Combination of Punica granatum Fruit Rind and Theobroma cacao Seed Extracts Enhances Sexual Function in Aging Males in a Randomized, Double-blind, Placebo-controlled Study. Int J Med Sci. 2025 Jan 1;22(2):383-397. doi: 10.7150/ijms.99958. eCollection 2025.
- Background: PubMed 35928723Pandit SL, Yaligar D, Halemane M, Bhat A. A proprietary blend of standardized Punica granatum fruit rind and Theobroma cocoa seed extracts mitigates aging males' symptoms: A randomized, double-blind, placebo-controlled study. Int J Med Sci. 2022 Jul 11;19(8):1290-1299. doi: 10.7150/ijms.73645. eCollection 2022.
- Background: PubMed 35129040Sreeramaneni PGA, Yalamanchi A, Konda MR, Cherukuri SHV, Maroon JC. A Proprietary Herbal Blend Containing Extracts of Punica granatum Fruit Rind and Theobroma cocoa Seeds Increases Serum Testosterone Level in Healthy Young Males: A Randomized, Double-Blind Placebo-Controlled Study. J Diet Suppl. 2023;20(3):411-427. doi: 10.1080/19390211.2022.2035037. Epub 2022 Feb 6.
- Background: PubMed 35571381Madireddy RK, Alluri KV, Somepalli V, Golakoti T, Sengupta K. Toxicological Assessments of a Proprietary Blend of Punica granatum Fruit Rind and Theobroma cacao Seed Extracts: Acute, Subchronic, and Genetic Toxicity Studies. J Toxicol. 2022 May 6;2022:3903943. doi: 10.1155/2022/3903943. eCollection 2022.
- Background: PubMed 27610134Asiedu-Gyekye IJ, Frimpong-Manso S, N'guessan BB, Abdulai Seidu M, Osei-Prempeh P, Kwaku Boamah D. Macro- and Microelemental Composition and Toxicity of Unsweetened Natural Cocoa Powder in Sprague-Dawley Rats. J Toxicol. 2016;2016:4783829. doi: 10.1155/2016/4783829. Epub 2016 Aug 17.
- Background: PubMed 35234023Boroujeni SN, Malamiri FA, Bossaghzadeh F, Esmaeili A, Moudi E. The most important medicinal plants affecting sperm and testosterone production: a systematic review. JBRA Assist Reprod. 2022 Aug 4;26(3):522-530. doi: 10.5935/1518-0557.20210108.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing LN18178 in people with Healthy Human Volunteers, run by GENCOR Lifestage Solutions.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mr Machiraju Garga (+91 8331015019, machiraju.gls@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in motility (% Motile Sperms) using manual microscopic examination. (time frame: Screening, weeks 8, 12 & 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07109622, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2025; AzTrials last refreshed its copy on 6 Nov 2026.