Studying the effectiveness of topical blend of herbal extracts in alleviating stress and improving mood in adults.

Not Applicable

• Conditions: Health Condition 1: F99- Mental disorder, not otherwise specified

• Registration Number: CTRI/2023/09/057910
• Lead Sponsor: Sush Essentials Pvt. Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 16 October 2023

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Subjects meeting all of the following criteria will be eligible for the study:

1.Healthy male or female 25-55 years of age at the time of obtaining written informed consent

2.Subjects willing to sign inform consent form

3.A female participant who is of reproductive potential has a negative pregnancy test and agrees to use contraception throughout the study period

4.Subjects are free of anti-depressants /anti-anxiety/ mood enhancing/recreational drugs intake for at least one year at the start of the screening visit

5.Subjects are free of any ‘‘over the counter’’ or prescribed medications at the start of the screening visit

6.Subjects with a score of 7-26 on the Perceived Stress Scale (PSS)

7.Willing to abstain alcohol, caffeine, and nicotine consumption while in the study

8.No reported history of psychological or mental disorders.

9.Free of psychiatric conditions other than perceived stress

Exclusion Criteria

Subjects meeting any of the following criteria will not be eligible for the study:

1.Resting systolic blood pressure above 140 mmHg or a diastolic blood pressure above 90 mmHg at baseline visit.

2.Taking any medicine or dietary supplements within the last 3 months to help to relieve sleep disturbances or physiological stress

3.History of substance abuse or dependence

4.Taking certain prohibited medications

5.Habitual smoking or vaping of products nicotine containing tetrahydrocannabinol (THC) with an average consumption >2 cigarettes or vaping more than 2 times per day

6.History of malignancy less than or equal to 5 years prior to signing an informed consent

7.Other conditions, which in the opinion of the investigators, makes the subject unsuitable for enrolment or could interfere with his/her participation in, and completion of the protocol.

8.Any known allergy or intolerance to any of the ingredients contained in supplements

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary EndpointsAssessment of changes in- <br/ ><br>1.Perceived stress by perceived stress scale (PSS) score questionnaire will be assessed from screening and day 21 <br/ ><br>2.Cortisol levels will be assessed at screening and day 21Timepoint: from screening and day 21

Secondary Outcome Measures

Name	Time	Method
Secondary EndpointsAssessment of changes in- <br/ ><br>1.Measurement of mood on the POMS scale (Profile of mood state questionnaire) will be assessed from screening and day 21 <br/ ><br>2.Anxiety by using Hamilton Anxiety Rating Scale (HAM-A) score will be assessed at screening and day 21 <br/ ><br>3.Fatigue using Fatigue Severity Scale (FSS) will be assessed from screening and day 21 <br/ ><br>4.Changes in symptoms sweating, palpitations, headache, muscle pain/ body ache, fatigue, loss of appetite and irregular bowels will be assessed from screening and day 21Timepoint: from screening and day 21