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Safety, Tolerability and Sensory evaluation of HTUL-031908

Phase 1
Registration Number
CTRI/2022/04/041874
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
Inclusion Criteria

Each subject must meet all the following criteria to be enrolled in this study:

1) Adult volunteers of either sex with good health.

2) Aged between �18 to � 60 years.

3) Subjects willing to sign informed consent and follow the study procedure and instructions.

4) Has not participated in a similar investigation in the past four weeks.

5) Women in reproductive age group who will agree to follow an acceptable contraceptive method.

Exclusion Criteria

Subjects meeting any of the following criteria will be excluded from the study:

1) Subjects with clinically significant cardiovascular, cerebrovascular, respiratory, liver, renal disease, congenital or any other systemic condition requiring therapeutic intervention.

2) A known history or present condition of allergic response to pharmaceutical products its components or ingredients in the test products.

3) Pre-existing systemic disease necessitating long-term medications.

4) Genetic and endocrinal disorders.

5) Pregnant and lactating women.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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