A Clinical Study to Evaluate the Efficacy and Safety of ThymoDream(TM) in Comparison with Melatonin in healthy volunteers with poor sleep quality.

A Randomized, Double-Blind, Active-Controlled, Cross-over, Clinical Study to Evaluate the Efficacy and Safety of ThymoDream(TM) in healthy volunteers with poor sleep quality. - NIL

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/11/077454

Enrollment

Registered

2024-11-28

Start date

Unknown

Completion date

Unknown

Last updated

2024-12-09

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

Conditions

None listed

Interventions

Intervention1: ThymoDream™ capsule: Oral administration of ThymoDream™ capsule once a day for 7 days Control Intervention1: Melatonin capsule: Oral administration of Melatonin capsule once a day for 7

Eligibility

Inclusion criteria

Inclusion criteria: 1. Pittsburgh Sleep Quality Index (PSQI) scores between 5-15 2. Can read and write English. 3. No history of psychiatric conditions 4. Should be ready to abstain from alcohol consumption, smoking and consumption of caffeinated beverages. 5. Should be ready to be housed during the study as per the protocol requirement. 7. Should be willing to adhere with their routine diet and exercise regimen throughout the study. 8. Must be willing and able to give informed consent and comply with the study procedures.

Exclusion criteria

Exclusion criteria: 1.Subject suffering from mental disorders, clinical anxiety, depression, Cushing’s syndrome and other major ailments. 2.Subjects on medication/dietary supplements that may affect the measured responses, including medicines for sleep disorders, anxiety, depression; prednisone, dexamethasone and other steroids administered orally or intravenous 3.Alcohol addicts, smokers of more than 10 cigarettes/day. 4.Pregnant and lactating women 5.Subjects on hormonal birth-control measures 6.Subjects currently on any medication on a regular basis. 7.Subjects allergic to herbal products, nuts or any component of the study product 8.Currently participating or having participated in another clinical trial during the last 3 months prior to the beginning of this study 9.Any additional condition(s) that in the Investigators opinion would warrant exclusion from the study or prevent the subject from completing the study.

Design outcomes

Primary

Measure	Time frame
Mean change in the following parameters in ThymoDream™ arm compared to melatonin from baseline to end of treatment (EOT): - Melatonin profiling - BiomarkersTimepoint: Baseline and Day 7	—

Secondary

Measure	Time frame
Mean change in the following parameters in ThymoDream™ arm compared to melatonin from baseline to EOT: •Wrist actigraphy parameters: •Sleep disturbance assessed by (ESS Score) Timepoint: Baseline, Day 3, Day 6;Safety ParametersTimepoint: Baseline, Day 3, Day 6	—

Countries

India

Contacts

Public ContactJestin V Thomas

Leads Clinical Research and Bio Services Pvt. Ltd

jestin.leadsclinbio@gmail.com9845125293

Outcome results