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â??Safety study of Quista - Isolate in Healthy Adult Volunteers

Phase 1
Registration Number
CTRI/2020/09/028141
Lead Sponsor
The Himalaya Drug Company
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Open to Recruitment
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

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 nutritional supplement

during the study period

Exclusion Criteria

1. Subjects with clinically significant serious cardiovascular,

cerebrovascular, respiratory, liver,

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
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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