Clinical trial of stress and Sleep management supplement

A Prospective, randomized controlled study to evaluate safety and efficacy of stress and Sleep management supplement - Nil

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/07/070701

Enrollment

120

Registered

2024-07-16

Start date

Unknown

Completion date

Unknown

Last updated

2024-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Life synergy stress management formula: 3 gm of powder with Milk/Water at Bed time daily for 60 days Intervention2: Life synergy aromatic stress management formula: Apply roll on to for

Eligibility

Inclusion 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

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

Design outcomes

Primary

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

Secondary

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

Countries

India

Contacts

Public ContactDr Vaishnavi Patil

Life Synergy

vaishnavilifesynergy@gmail.com9834585994

Outcome results