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Clinical study of Aromatherapy Oil in females suffering from stress related anxiety

A Prospective, Multi-center, Clinical Study to Evaluate the Efficacy and Safety of Aromatherapy Oil in females suffering from mild to moderate stress induced anxiety - NIL

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2016/03/006715
Enrollment
48
Registered
2016-03-07
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

Health Condition 1: null- Stress Induced Anxiety

Interventions

Intervention1: Aromatherapy Oil: Contains Refined Coconut oil and Refined Sunflower oil Dosage and Treatment Duration: Subjects will be advised to apply sufficient quantity of Study oil daily for 15

Sponsors

Marico Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: •Subjects with mild to moderate stress induced anxiety (who achieved score between 18 and 24 points on the Hamilton Scale for Anxiety) were considered eligible for recruitment in the Study •Subjects who gave informed consent and were ready to comply with the study protocol •Subjects who were ready to provide regular follow ups till the completion of the study

Exclusion criteria

Exclusion criteria: •Subjects suffering from depression, schizophrenia, diabetes mellitus, cardiovascular disease (uncontrolled arrhythmia / acute ischemia) and kidney and liver diseases will not be recruited in the Study •Subjects having addiction to drugs, including alcohol were not recruited in the Study •Subjects who were using any medication that could interfere with the effect of the oil under study were not recruited in the study •Subjects who had participated in any other clinical study in the last 3 months were not included in the study •Subjects who reported pregnant/planning a pregnancy or lactating were not recruited in the study

Design outcomes

Primary

MeasureTime frame
Improvement in Hamilton Rating scale for Anxiety (HAM-A) score with Study oil as compared to Baseline score in mild to moderate stress induced anxietyTimepoint: Day 0, Day 7 and Day 15

Secondary

MeasureTime frame
â?¢Changes in QOL in subjects suffering from mild to moderate stress induced anxiety â?¢Changes in Morning serum cortisol value in subjects suffering from mild to moderate stress induced anxiety. â?¢Changes in the level of stress measured on VAS scale â?¢Changes in the quality of Sleep â?¢Assessment of adverse eventsTimepoint: Day 0, Day 7 and Day 15

Countries

India

Contacts

Public ContactDr Sanjay Tamoli

Target Institute of Medical Education and Research

targetinstitute@yahoo.com9322522252

Outcome results

None listed

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