CTRI/2024/03/064117
Not yet recruiting
Phase 2
Assessment of safety and efficacy of Nutraceutical supplements/AYUSH medicines in healthy human volunteers. - NI
HERBOLAB INDIA PVT LTD0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- HERBOLAB INDIA PVT LTD
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Healthy male and female human trial participants aged between 18 and 60 years (both inclusive);2\. Female trial participants must have a negative urine pregnancy test prior to the housing;3\. Male and females agreeing to use the contraceptive pill or abstinence as a method of contraception during and 07 days after completion of the study;4\. Trial participants with a BMI between 18\.50\-29\.90 kg per m2 and body mass, not less than 50\.00 kg;5\. Trial participants in normal health as determined by personal medical history, clinical examination including vital signs, and clinically acceptable results of laboratory examinations (including serological tests).
Exclusion Criteria
- •1\.Incapable of understanding the informed consent information;
- •2\.Clinically significant medical condition, such as, but not limited to,
- •cardiovascular, neurological, psychiatric, pulmonary, renal,
- •immunological, endocrine (including uncontrolled diabetes or thyroid
- •disease), or uncontrolled haematological abnormalities;
- •3\.History or presence of alcoholism or drug abuse;
- •4\.History or presence of cancer;
- •5\.Use of any prescribed medication (including herbal remedies)
- •during the two weeks before the start of the study or OTC medicinalproducts (including herbal remedies) during the week before study initiation and throughout the study;
- •6\.Major illness during the 90 days before screening;
Outcomes
Primary Outcomes
Not specified
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