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A study to see how Ayurvedic detox therapy and internal medication improve semen quality and sperm DNA health in men planning to become fathers.

An open-label, double-arm randomized controlled trial to explore the effect of Shodhana and Swayamguptadi granules with Vanga Bhasma orally on semen parameters and sperm DNA integrity in preconception care - NIL

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/06/088697
Enrollment
60
Registered
2025-06-12
Start date
Unknown
Completion date
Unknown
Last updated
2025-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

None listed

Sponsors

Institute of Teaching and Research in Ayurveda
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Male participants aged from 21 to 40 years Normal semen parameters according to WHO 2021 No significant systemic or reproductive anatomical abnormalities confirmed through hematological serological and urine investigations and USG of the abdomen pelvis and scrotum Willing to provide written informed consent to participate in the study Eligible for Snehapana and Shodhana

Exclusion criteria

Exclusion criteria: Abnormal semen analysis parameters as per WHO 2021 thresholds Presence of significant systemic illnesses such as diabetes mellitus cardiovascular diseases or hepatic renal dysfunction History of varicocele, hydrocele or any reproductive tract inection. History of surgical interventions in the reproductive system. Participants undergoing concurrent treatment for infertility or on hormonal therapy. Known hypersensitivity or contraindications to any components used in the study treatment. Presence of significant abnormalities detected in hematological serological or urine investigations. Participants not willing to provide consent.

Design outcomes

Primary

MeasureTime frame
Improvement in Semen Quality based on sperm count, motility, morphology and volume. Reduction in Sperm DNA Fragmentation Index (DFI) Timepoint: After treatment - after 3 months of internal medication Follow-up - follow-up will occur 21 days after treatment completion

Secondary

MeasureTime frame
Optimization of Hormonal Levels of FSH, LH and Testosterone. Enhancement in International Index of Erectile Function (IIEF) scores after the intervention compared to baseline. Conception Success Timepoint: After treatment - after the administration of the therapeutic intervention, will be 3 months and 15 days. The first follow-up will occur 21 days after treatment completion, during which repeat semen analysis to observe sustained or progressive improvements. A second follow-up will be scheduled 6 months post-treatment to evaluate the feasibility of conception success.

Countries

India

Contacts

Public ContactDr Mandip Goyal

Institute of Teaching and Research in Ayurveda

mandipgoyal@itra.edu.in9427572306

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026