Evaluation of Safety and Tolerability of HOAW-062101 in Healthy Adults
- Registration Number
- CTRI/2023/03/051001
- Lead Sponsor
- Himalaya Wellness Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1. Healthy adult subjects of either sex aged between >=18 to <=50 years.
2. Subjects willing to sign informed consent and follow the study procedure.
3. Has not participated in a similar investigation in the past four weeks.
4. Subjects willing to refrain taking any other similar supplements during the study period
1.Subjects with clinically significant serious cardiovascular, cerebrovascular, respiratory, liver, renal disease, congenital or any other disorder.
2.Subjects with any abnormal lab values detected at screening shall be excluded.
3.A known history or present condition of allergic response to pharmaceutical products its components or ingredients in the investigational products (IP).
4.Pre-existing systemic disease necessitating long-term medications.
5.Genetic and endocrinal disorders.
6.Subjects who refused to sign informed consent.
7.Pregnant and lactating women.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of any adverse or serious adverse events reported or observed during the study period for 7 daysTimepoint: Incidence of any adverse or serious adverse events reported or observed during the study period for 7 days
- Secondary Outcome Measures
Name Time Method Overall compliance of the subject to the study medicationTimepoint: 7 days