Health Condition 1: N468- Other male infertility
Conditions
Interventions
Intervention1: Meet Shilajeet-K: 1. Fulvic acid
2. Levodopa
Control Intervention1: Nil: Nil
Sponsors
Herbal Creations
Eligibility
Inclusion criteria
Inclusion criteria: 1. Men diagnosed with abnormal semen parameters during the screening period, defined as any of the following: Sperm concentration less than 20 million per mL, and Progressive sperm motility less than 32 percent, and Normal sperm morphology less than 4 percent. 2. Willing and able to provide semen samples during the screening and at end of study following 2 to 4 days of sexual abstinence for each sample. 3. Consumed any nutraceuticals over the counter supplements or herbal remedies to manage semen abnormalities including oligospermia, asthenozoospermia, teratozoospermia or oligoasthenoteratozoospermia within 30 days prior to screening and baseline visit.
Exclusion criteria
Exclusion criteria: The study will exclude individuals meeting any of the following criteria: 1) History of infertility due to non-oligospermic causes (e.g., obstructive azoospermia, genetic disorders). 2) Individuals with azoospermia or necrospermia/ necrozoospermia. 3) Chronic use of medications affecting spermatogenesis (e.g., anabolic steroids, chemotherapy). 4) Clinically significant medical conditions, including but not limited to cardiovascular, neurological, psychiatric, renal, hepatic, immunological, endocrine (such as uncontrolled diabetes or thyroid disease), or haematological abnormalities. 5) Individuals with a history of mumps, measles, smallpox, chicken pox, tuberculosis or injury to genitalia in the preceding 10 years. 6) Known hypersensitivity or allergy to Shilajit or its components. 7) Participation in any other clinical trial within the last 3 months. 8) Current heavy smokers (Greater 20 cigarettes/day) or participants with ongoing hazardous alcohol consumption (Greater 14 standard drinks/week).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Change in sperm concentration from baseline to end of supplementation. 2. Change in total sperm count from baseline to end of supplementation. 3. Change in sperm motility total, progressive, non-progressive, and immotile from baseline to end of supplementation. 4. Change in sperm morphology normal and abnormal forms from baseline to end of supplementationTimepoint: Day 0 and Day 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| a. Pus cells, epithelial cells, red blood cells. b. Agglutination or AggregationTimepoint: Day 0 Day 30 Day 60 Day 90 | — |
Countries
India
Contacts
Public ContactMeena Dalal
TrialGuna Private Limited
Outcome results
None listed