Effect of Herbal Supplement on Improving Sperm Virility

Официальное название

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)

Обзор

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

Подробное описание

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.

Вмешательства

• Пищевая добавка LN18178
  400 mg, One capsule to be consumed in the morning after breakfast for 12 weeks.
• Пищевая добавка Placebo
  One capsule to be consumed in the morning after breakfast for 12 Weeks

Первичные конечные точки

• Change in motility (% Motile Sperms) using manual microscopic examination. [Срок оценки: Screening, weeks 8, 12 & 16]

Вторичные конечные точки (12)

• Change in semen Concentration (millions/mL) using manual microscopic examination. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: Screening, Weeks 12 & 16]
• Change from baseline to the end of the study period in International Index of Erectile Function (IIEF-15) [Срок оценки: 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) [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Baseline (day 1), Weeks 12 &16]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.
• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Организация здравоохранения

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• 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. PMID 33032908
• Shabsigh 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. PMID 15247755
• Pandit 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. PMID 26395129
• Yoon 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. PMID 26581682
• Wang-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. PMID 16794456
• Forest 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. PMID 17568759
• Srivastava 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. PMID 39781534
• Pandit 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. PMID 35928723

Идентификаторы

NCT: NCT07109622 · GNC/SV/LN18178/25

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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