None listed
Conditions
Interventions
None listed
Sponsors
Dabur India Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Participants who perceive themselves to be under stress and having a score of between 14 - 24 on the Perceived Stress Scale (PSS) 2. Participants with insomnia severity more than 7 and less than or equal to 21 on insomnia severity index 3. Participants willing to follow the procedures as per the study protocol and voluntarily sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Participants currently suffering from any known chronic physical, hormonal or psychiatric illness 2. Participants with uncontrolled diabetes and hypertension 3. Participants with substance dependence e.g. taking prohibited medications such as opium, cannabis (marijuana) and methamphetamines etc. 4. Chronic alcoholics and Habitual Tobacco chewers. 6. Known cases of severe/chronic hepatic or renal disease. 7. Known case of any active malignancy. 8. Participants with history of cardiovascular event less than 12 weeks prior to recruitment. 9. Participants having known chronic, contagious infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV. 10. Participants using any other investigational drug within 1 month prior to recruitment or participants currently participating in any other Clinical study 11. Known hypersensitivity to any of the ingredients used in study products 12. Participants with any current skin or scalp related medical or surgical condition 13. Pregnant and Lactating females. 14. Other conditions, which in the opinion of the investigators, make participant unsuitable for enrolment or could interfere with his/her participation and completion of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Change in stress level using perceived stress scale (PSS) 2.Change in patient-reported total sleep time (as per Participant diary) Timepoint: Day 0, Day 7 and Day 14 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Assessment of relaxation, cooling, refreshing, soothing on VAS and time duration of relaxation, cooling, refreshing, soothing post application 2. Change in sleep efficiency, Time to sleep onset. Number of awakenings, Wake time after sleep onset 3. Change in fatigue using Fatigue Severity Scale 4. Change in headache mood, ability to function at work, and concentration on a graded scale 5. Change in severity of insomnia using Insomnia Severity Index 6. Change in quality of sleep using Pittsburgh Sleep Quality Index 7. Change in hair fall through running finger test, comb test pull test and Dandruff test 8. Change in quality of life using Q LES Q SF 9. Changes in morning serum cortisol level 10. Assessment of adverse events and vitals 11. Global assessment for overall change 12. Assessment of post study tolerability of study product Timepoint: Day 0, Day 7 and Day 14 | — |
Countries
India
Contacts
Public ContactDr Sanjay Tamoli
Dabur India Ltd.
Outcome results
None listed