Health Condition 1: Z733- Stress, not elsewhere classified
Conditions
Interventions
None listed
Sponsors
Mr. Heet Nagda
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female participants aged 18 to 65 years. 2. PSS >= 14 at baseline for inclusion. 3. SHSS score indicating mild or moderate dryness (depending on your scale range) to ensure there is room to measure improvements in skin nourishment. 4. Willing and able to provide written informed consent. 5. Willing to comply with the study procedures, including regular application of the investigational product and attendance at all study visits.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women. 2. Participants with any severe, life-threatening, or unstable medical condition (e.g., cardiovascular disease, liver or kidney disease). 3. Known hypersensitivity to any of the ingredients in the investigational product. 4. Current or recent (within 2 months prior to screening) use of psychotropic medications, including anti-stress, anti-depressant, or antipsychotic agents. 5. History of alcohol or drug abuse within the last 6 months. 6. Participants who have participated in another clinical trial within the last 3 months. 7. History of head injury, epilepsy, or other significant neurological disorders. 8. Any psychiatric conditions other than the daily stress, such as schizophrenia, major depression, or bipolar disorder. 9. Participants who, in the opinion of the investigator, are unlikely to comply with the study protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Stress Relief Efficacy: -The primary endpoint is the change in perceived stress levels from baseline to Day 45, as measured by the Perceived Stress Scale (PSS). A significant reduction in PSS scores from baseline will indicate the efficacy of Calm Body Cream in alleviating stressTimepoint: Day1, day 15, Day 30 and Day 45 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Skin Nourishment Improvement: Evaluation of skin hydration and smoothness from baseline to Day 45 using the Skin Hydration and Smoothness Scale (SHSS), based on assessments by both the clinician and participant. 2. Clinical Improvement in Stress and Skin Condition: Monitored using CGI-I (improvement relative to baseline) and CGI-S (severity of stress and skin condition over time). 3. Safety and Tolerability: Continuous monitoring of adverse events (e.g., redness, itching, swelling). Confirmation of safety through the absence of severe dermatological reactions related to Calm Body Cream.Timepoint: Day1, day 15, Day 30 and Day 45 | — |
Countries
India
Contacts
Public ContactMs Arpita Malgi
Samahitha Research Solutions
Outcome results
None listed