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Clinical Trials/CTRI/2024/07/070701
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.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Interventional

Investigators

Sponsor
ife Synergy

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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