CTRI/2009/091/000551CompletedPhase 4
Evaluation of oxidative stress as a cause for idiopathic male infertility and the role of Addyzoa in its treatment
Dr Rajeev Kumar1 site in 1 country50 target enrollmentStarted: March 15, 2009Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Improvement in semen parameters
Study Overview
Brief Summary
Addyzoa is a herbomineral product. It is promoted as a spermatogenic antioxidant that scavenges free radicals and reduces oxidative stress. This randomized, double blind, placebo controlled parallel group study aims to evaluate its benefits in men with idiopathic oligo/astheno/teratozoospermia.
Study Design
- Allocation
- Random Number Table
- Masking
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
Eligibility Criteria
Inclusion Criteria
- •Infertile male, normal semen volume with either oligospermia (sperm density between 5 and 20 million/mL) or asthenospermia or teratospermia by WHO criteria.
Exclusion Criteria
- •Identifiable cause for semen abnormality (varicocele, cryptorchidism, orchitis, radiation, chemotherapy, recent febrile illness, hormonal abnormality etc).
Outcomes
Primary Outcomes
Improvement in semen parameters
Time Frame: 3 months and 6 months
Secondary Outcomes
- Pregnancy(Upto 12 months)
Investigators
Study Sites (1)
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