A single-dose, single period of comparing Formulated Curcumin based drink with Unformulated Curcumin based drink manufactured by Sipwise Beverage Pvt Ltd, in healthy, subjects under fed conditions.

An open-label, randomized, single-dose, two-treatment, single period, parallel oral bioavailability study of Formulated Curcumin based drink manufactured by Sipwise Beverage Pvt Ltd, Vadodara, Gujarat, India comparison with Unformulated Curcumin based drink manufactured by Sipwise Beverage Pvt Ltd, Vadodara, Gujarat, India in healthy, adult, human subjects under fed conditions.

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/09/027701

Enrollment

Registered

2020-09-10

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: Formulated curcumin based drink: Sipwise Beverage Pvt Ltd,Single-Dose, Two-Treatment, Single-Period,orally administered Control Intervention1: Unformulated curcumin based drink manufact

Eligibility

Inclusion criteria

Inclusion criteria: Healthy adult human volunteers of age between 18-45 years

Exclusion criteria

Exclusion criteria: Evidence of allergy or known hypersensitivity to Curcumin and its inactive ingredients. Subjects with hepatic encephalopathy, cholestasis, myasthenia, pre-existing liver disease, alcohol abuse and recently overcome or active existing tinnitus. Subjects with acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. Any major illness in the last three months or any significant ongoing chronic medical illness. Any disease or condition which might compromise the haemopoeitic, gastrointestinal,renal, hepatic, cardiovascular, musculoskeletal, respiratory, central nervous system, diabetes, psychosis or any other body system. History of drug abuse within 03 months (including benzodiazepines, opioids, cocaine, barbiturates, THC and amphetamine etc.) History of alcohol addiction or abuse. History of difficulty in swallowing. History of difficulty in accessibility of veins. Any blood donation / excess blood loss within 90 days of check-in. Subject who had participated in any other study within the 90 days of study check-in. Consumption of caffeine and /or Xanthine containing products (i.e. coffee, tea, chocolate, and caffeine-containing sodas, colas, etc.) and tobacco containing products for at least 24.00 hours prior to check-in and throughout the entire study. Consumption of alcohol and its products, grapefruit and/ or its juice and poppy containing foods within 72.00 hours prior to clinic admission and throughout the entire study. Use of any prescribed medication within 14 days and any over the counter medicinal products, herbal medications, etc. within 07 days prior to study check in and throughout the study.

Design outcomes

Primary

Measure	Time frame
Bio availabilityTimepoint: 18 time points, 00.00, 00.25, 00.50, 01.00, 01.50, 02.00, 02.25, 02.50, 03.00, 03.50, 04.00, 05.00, 06.00, 07.00, 08.00, 10.00, 12.00, 24.00	—

Secondary

Measure	Time frame
To assess the safety of trial subjects during the study.Timepoint: 18 time points, 00.00, 00.25, 00.50, 01.00, 01.50, 02.00, 02.25, 02.50, 03.00, 03.50, 04.00, 05.00, 06.00, 07.00, 08.00, 10.00, 12.00, 24.00	—

Countries

India

Contacts

Public ContactDr Reenee Rajan MBBS MD

Micro Therapeutic Research Labs Pvt. Ltd.

reenee@microtheraps.com9940502533

Outcome results