Clinical trial ofstress and Sleep management supplement

Phase 3

Registration Number: CTRI/2024/07/070701

Lead Sponsor: ife Synergy

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1.Subjects of age between 18 and 60 years;2.Free of psychiatric conditions other than perceived stress;3.Have a score less than or equal to 20 to more than or equal to 12 on the World Health Organization–five (WHO-5) well-being index;4.Subjects with or without diabetes or hypertension (If any comorbidity present the subject should be on stable prescription;5.Participants diagnosed with mild insomnia based on the Hamilton Depression Questionnaire

Exclusion Criteria

1.History or diagnosis of another sleep disorder

2.Difficulty sleeping due to a medical condition

3.History of a neurological disorder

4.History of bipolar disorder, psychotic disorder, or posttraumatic stress disorder, or current psychiatric disorder that requires medication

5.History of substance abuse or dependence

6.Known hypersensitivity to any of the ingredients of intervention

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Reduction in stress on perceived stress scale <br/ ><br>2.Profile of mood states (POMS-2) <br/ ><br>3.Patient-reported total sleep time. <br/ ><br>4.Patient-reported time to sleep onset <br/ ><br>5.Patient- reported number of awakenings <br/ ><br>6.Graded symptom scale for irritation, poor concentration and weak memory <br/ ><br>7.Hamilton Depression Rating <br/ ><br>8.Changes in serum cortisol levelTimepoint: From baseline to 60 days of medication

Secondary Outcome Measures

Name	Time	Method
1.Symptom grading for hyperacidity and other GI symptoms like constipation and indigestion/bloating <br/ ><br>2.Daytime fatigue using Fatigue Severity Scale (FSS) <br/ ><br>3.Worklife efficiency scale <br/ ><br>4.DSM-IV questionnaire <br/ ><br>5.Drug compliance <br/ ><br>6.Tolerability of study drugs <br/ ><br>7.Adverse events/ Adverse drug reactionsTimepoint: From baseline to 60 days of medication