A Clinical Study To Assess The Safety, Tolerability And Sensory Evaluation Of The Test Product
- Registration Number
- CTRI/2022/07/043803
- 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 volunteers 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 anti-viral medication during the study period
1. Subjects with clinically significant serious cardiovascular
cerebrovascular, respiratory, hepatic, renal disease, congenital or
any other disorder.
2. A known history or present condition of allergic response to
pharmaceutical products its components or ingredients in the test
product.
3. Pre-existing systemic disease necessitating long-term medications.
4. Genetic and endocrinal disorders.
5. Subjects who refused to sign informed consent.
6. Pregnant and lactating women.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Occurrence of any adverse or serious adverse <br/ ><br>events during the study period.Timepoint: Visit 1 / Day 1 <br/ ><br>Visit 2 / Day 4
- Secondary Outcome Measures
Name Time Method Overall compliance of the subject to the study <br/ ><br>medicationTimepoint: Visit 1 / Day 1 <br/ ><br>Visit 2 / Day 4