Evaluation of Safety and Tolerability of Salvia Haenkei Extract As a Dietary Supplement Ingredient
Recruiting now · Not applicable
Conditions studied: Aging
In brief
Evalution of the safety and tolerability of the oral administration of Salvia haenkei in a healthy population.
Key facts
- Study ID
- NCT05936346
- Run by
- IBSA Farmaceutici Italia Srl
- People needed
- 50
- Starts
- 2023-07-17
- Expected to finish
- 2025-04-30
- Last updated by the study team
- 2025-01-23
Who can join
Age: 55 and older, up to 65. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Informed consent as documented by signature
- Male or female
- Age 55-65 years, inclusive
- In good general health as evidenced by medical history and current health status
- Willingness to maintain dietary and sports habits as of baseline
- Willingness and ability to comply with the requirements of the study
You may not qualify if…
- Body Mass Index < 18.5 or ≥ 30
- Difficulty in swallowing (dysphagia)
- Known allergy or sensitivity to any ingredient of the study intervention
- Any medical condition or clinically significant abnormalities in laboratory values (hematology, blood chemistry, urinalysis) at screening which in the judgment of the Investigator makes the subject unsuitable for the study
- Planned or anticipated major surgical procedure during the subject's participation in this study
- Inability or contraindications to undergo the study intervention
- Inability to follow the procedures of the study (e.g. due to language problems, psychological disorders, dementia, etc.)
- Use of any new vitamins, herbal or dietary supplements, functional foods and sports drink, of any kind, liable or presented as liable to enhance physical performances within one month prior to the start and during the study
Where it is running
- Ospedale Regionale di Lugano — Lugano, Switzerland (enrolling)
Full record on ClinicalTrials.gov
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