DRKS00012868CompletedPhase 3
Efficacy of NSF on acute stress - NMC1-2017
MC Lab SAS0 sites20 target enrollmentStarted: August 11, 2017Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 20
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Non-randomized controlled study
- Masking
- Blinded (masking used)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (—)
- Sex
- All
Inclusion Criteria
- •pre-menopausal women must use hormonal contraception (for 3 months or more)
Exclusion Criteria
- •- smoker (> 5 cigarettes / day)
- •- any known allergies to the test substances
- •- any known addiction to drugs and alcohol
- •- hyper- or hypotension (except for those whose blood pressure is stable using medication for more than 3 months)
- •- known hyper- or hypothyroidism unless treated and under control (stable for more than 3 months)
- •- intake of dietary supplements or homoeopathic remedies during 2 weeks before V1
- •- on a strict diet or practicing sport, extensively
- •- any other known current/acute or chronic physical or psychological diseases besides minor medical conditions (e.g. seasonal allergies)
- •- subjects having previously participated in the TSST
- •- pregnant or lactating females or females planning a pregnancy within the next 3 months
- •- post-menopausal women using hormonal medication for less than 3 months
- •- employee of the sponsor or Clinical Research Organization (CRO)
- •- Investigator doubts truthfulness of self-reported health information
- •- not suitable because of limited verbal and cognitive abilities
- •- on vacation within the last 2 weeks
Investigators
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