Health Condition 1: G479- Sleep disorder, unspecified
Conditions
Interventions
Intervention1: Sleep Support Supplement (GPLIFE/PROD/2025/007): 1 Tablet at night, 30 minute before sleep
Control Intervention1: Placebo: 1 Tablet at night, 30 minute before sleep
Sponsors
Dr Chetan H Savaliya
Eligibility
Inclusion criteria
Inclusion criteria: Participants meeting all the following criteria will be eligible for the study: 1.Male and female participants aged 21 to 50 years (both inclusive); 2.Suffering from self-reported mild to moderate stress on the PSS scale score less than and equals to 26; 3.Participants willing to participate in clinical trials and who have read understood and signed the informed consent form; 4.Participants diagnosed with insomnia disorder based on the Diagnostic and Statistical Manual of Mental Disorders, text revision (DSM V TR); 5.Insomnia Severity Index more than 7 and less than 21 i.e. mild to moderate; 6.Participants with a diagnosis of mild or moderate depression (patients health questionnaire (PHQ 9) score of less than and equals to 14); 7.Participants with a diagnosis of mild or moderate generalized anxiety disorder (GAD) 7 questionnaire score of less than and equals to 10.
Exclusion criteria
Exclusion criteria: Participants meeting any of the following criteria will not be eligible for the study: 1.Difficulty sleeping due to a medical condition; 2.History of a neurological disorder; 3.History of bipolar disorder, psychotic disorder, or posttraumatic stress disorder, or current psychiatric disorder that requires medication; 4.On going depression and generalized anxiety disorder (diagnosis on PHQ 9 score greater than and equals to 15 and GAD-7 score greater than and equals to 11 scales); 5.History of substance abuse or dependence; 6.History or current evidence of a clinically significant cardiovascular disorder at pre-study visit; 7.Taking certain prohibited medications; 8.Consumption of greater than 10 cigarettes a day; 9.current evidence or history of malignancy less than and equals to 5 years prior to signing informed consent; 10.Participants currently using any nutraceutical, allopathic, or ayurvedic supplement for stress or insomnia management; 11.Known hypersensitivity to any ingredients of product; 12.Pregnant or lactating women, as well as women of childbearing potential who are not using contraception or intending to conceive during the study; 13.Other conditions, which in the opinion of the investigators, makes the participant unsuitable for enrolment or could interfere with his/her participation in, and completion of the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Changes in Pittsburgh Sleep Quality Index (PSQI) score at screening and end of the study. 2.Changes in outcomes from participant sleep diary (total sleep time, sleep latency, number of awakenings, wake time after sleep onset and sleep efficiency. 3.Changes in Profile of Mood State abbreviated version (POMS A) score. 4.Changes in Insomnia Symptom Questionnaire (ISQ) score. Timepoint: Screening, Visit 1, Visit 2 and Visit 3 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Changes in perceived stress scale (PSS) score. 2.Safety parameters (CBC, LFT and RFT). 3.Assessment of adverse events. 4.Assessment of treatment compliance and tolerability of investigational. 5.Assessment of changes in vital sign parameters. Timepoint: Screening, Visit 1, Visit 2 and Visit 3 | — |
Countries
India
Contacts
Public ContactDr Dheeraj H Nagore
Gplife Healthcare Pvt. Ltd.
Outcome results
None listed