CTRI/2024/07/070701
Not yet recruiting
Phase 3
A Prospective, randomized controlled study to evaluate safety and efficacy ofstress and Sleep management supplement - Nil
ife Synergy0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- ife Synergy
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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