Clinical study of Oligocare Forte Plus versus placebo in sub-fertile males.

A prospective, randomized, double blind, placebo controlled, parallel arm study to assess the efficacy & safety of Oligocare Forte Plus versus placebo in sub-fertile males. - Nil

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/12/029590

Enrollment

300

Registered

2020-12-04

Start date

Unknown

Completion date

Unknown

Last updated

2022-10-17

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

Conditions

Health Condition 1: N461- Oligospermia

Interventions

Intervention1: Oligocare Forte Plus Tablets: Oligocare Forte Plus Tablets 1 tablet daily after meal for 90 days Control Intervention1: Placebo tablet: 1 tablet daily after meal for 90 days

Eligibility

Inclusion criteria

Inclusion criteria: Willingness to provide written informed consent to participate in the study and willing to follow up. The female partner was defined as being fertile Semen analysis indicating any 2 of the following criteria- Semen volume Sperm count Motile count Abnormal morphology DNA fragmentation >20% Subjects with Oligospermia, Asthenospermia, Teratospermia Female partners of the male subjects with reported pre-existing fertility disorders can still be considered.

Exclusion criteria

Exclusion criteria: General and endocrinological disease (clinical examination and routine hormonal laboratory tests) Previous or present cryptorchidism or genital obstruction. H/o Vasectomy, undescended testis, prostate cancer, varicocele, hydrocele. H/o chemotherapy or radiation for malignant conditions. H/o Azoospermia

Design outcomes

Primary

Measure	Time frame
To evaluate safety and efficacy of Oligocare Forte Plus by assessing- Total sperm count in sub-fertile male. Reduction in DNA Fragmentation in sub fertile male.Timepoint: Baseline to end of study i.e. day 90	—

Secondary

Measure	Time frame
To evaluate safety and efficacy of Oligocare Forte Plus by assessing following parameters in sub fertile male- Total semen volume Sperm motility Sperm morphology Overall pregnancy incidence amongst the study couple Timepoint: Baseline to end of study i.e. day 90	—

Countries

India

Contacts

Public ContactMr Sunil Kulkarni

Meyer Organics Pvt. Ltd.

tdcruz@meyer.co.in02225817126

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 10, 2026