Clinical Trial of Ayurvedic Medicinal Oil KK786 in stress related anxiety
- Conditions
- Health Condition 1: null- Stress Induced Anxiety
- Registration Number
- CTRI/2017/06/008796
- Lead Sponsor
- Emami Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
1.Subjects suffering from mild to moderate stress induced anxiety (who achieved scores between 18 and 24 points on the Hamilton Scale for Anxiety) were considered eligible for recruitment in the Study
2.Subjects who gave informed consent and were ready to comply with the study protocol
3.Subjects who were ready to provide regular follow ups till the completion of the study
1.Subjects suffering from depression, schizophrenia, diabetes mellitus, cardiovascular disease (uncontrolled arrhythmia or acute ischemia) and kidney and liver diseases were not recruited in the Study
2.Subjects who had addiction to drugs, including alcohol were not recruited in the Study
3. Subjects who were using any medication that could interfere with the effect of the oil under study were not recruited in the study
4. Subjects who had participated in any other clinical study in the last 3 months were not included in the study
5. Subjects who were reported pregnant or 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 KK786 oil as compared to Baseline score in mild to moderate stress induced anxiety.Timepoint: Day -3, Day 0, Day 14, Day 28 <br/ ><br>
- Secondary Outcome Measures
Name Time Method 1.Changes in QOL with KK786 Oil as compared to Baseline Value <br/ ><br>2.Changes in Morning serum cortisol value with KK786 oil as compared to Baseline Value <br/ ><br>3.Changes in the level of stress measured on VAS scale as compared to the baseline <br/ ><br>4.Changes in the quality of Sleep as compared to the baseline <br/ ><br>5.Assessment of effect of KK786 oil on headache, Fatigue, tiredness and Body ache <br/ ><br>6.Assessment of effect on Hair Fall <br/ ><br>7.Assessment of adverse events <br/ ><br>Timepoint: Day -3, Day 0, Day 14, Day 28 <br/ ><br>