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

â??Safety, Tolerability and Sensory Evaluation of HQIS-101904 in Healthy Adult Volunteers, An Open-Label Single-Arm Clinical Studyâ??

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/09/028141
Enrollment
24
Registered
2020-09-29
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Quista Isolate: Dosage: 1 sachet 31(g) HQIS-101904 (Chocolate flavor) with 200 ml of water (room temperature) Once daily for 7 days followed by 1 sachet (31g) of HQIS-101904 (Chocolate

Sponsors

The Himalaya Drug Company
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Healthy adult volunteers of either sex aged between >=18 to 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

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

Design outcomes

Primary

MeasureTime frame
Occurrence of any adverse or serious adverse events during the study PERIODTimepoint: Screening (Visit 1/ 7 days), day 1 (visit 2), day 7±1 (Visit 3/ Telephonic), day 14 ±1(visit 4) [EOS] along with sensory assessment

Secondary

MeasureTime frame
1. Sensory evaluation before and after the intervention 2. Overall compliance of the subject to the study medicationTimepoint: Screening (Visit 1/ 7 days), day 1 (visit 2), day 7±1 (Visit 3/ Telephonic), day 14 ±1(visit 4) [EOS] along with sensory assessment

Countries

India

Contacts

Public ContactMs Sushma C

The Himalaya Drug Company

dr.palani@himalayawellness.com9686681830

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026