Clinical study of Aromatherapy Oil in females suffering from stress related anxiety
- Conditions
- Health Condition 1: null- Stress Induced Anxiety
- Registration Number
- CTRI/2016/03/006715
- Lead Sponsor
- Marico Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 48
•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
•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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method â?¢Changes in QOL in subjects suffering from mild to moderate stress induced anxiety <br/ ><br>â?¢Changes in Morning serum cortisol value in subjects suffering from mild to moderate stress induced anxiety. <br/ ><br>â?¢Changes in the level of stress measured on VAS scale <br/ ><br>â?¢Changes in the quality of Sleep <br/ ><br>â?¢Assessment of adverse eventsTimepoint: Day 0, Day 7 and Day 15