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The Role negative emotions, worry, anxiety and high exercise activities in the routine life affecting the action of medicines in human beings.

The Influence of Psycho physiological Stressors and Hostile Factors on the Pharmacokinetics of Selected Drugs in Human Population

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2016/11/007464
Enrollment
20
Registered
2016-11-10
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: Moderate and high severe stress level people: Moderate and high severe stress level people will be analyzed for their hepatic CYP3A4 Metabolizing capacity by using probe drug Alprazolam

Sponsors

JSS University facility
Lead Sponsor
Abhilash Thomas
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: age 20 to 60 both sexes Normal body mass index Normal waist hip ratio Subjects who did not consult any doctor for Stress relief treatment either pharmacological (drug therapy) or non pharmacological treatments like Yoga meditation etc

Exclusion criteria

Exclusion criteria: Subjects who are on renal or hepatic impairment Subjects who are on treatment for any kind of disease or disorders including Steroid therapy

Design outcomes

Primary

MeasureTime frame
Primary outcome will be how different Stressors induces human body physiological functional changes leading to Hepatic CYP3A4 DYSREGULATION. If happens so the study drug to its metabolite ratio will be altered at every time pointsTimepoint: Within March of 2015

Secondary

MeasureTime frame
1. The results obtained by using Probe drug can be extrapolated to any substrate drug. 2. Changes in the Pharmacokinetic parameters of the substrate drug (e.g. Amlodipine) shall be measured in a particular non hospitalized patient to optimize the desired Pharmacokinetics for the better therapeutic outcome.Timepoint: within September of 2015

Countries

India

Contacts

Public ContactAbhilash Thomas

JSS College of Pharmacy

dr.malay.kmrsamanta@gmail.com9751615836

Outcome results

None listed

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