A clinical trial to study the effects of Sleep/ Well’ capsules in patients having difficulty in sleeping

Completed

• Conditions: Insomnia not due to a substance orknown physiological condition,

• Registration Number: CTRI/2022/11/047323
• Lead Sponsor: MOOM HEALTH PTE LTD

Brief Summary

All the subjects having problems initiating or maintaining sleep will be

enrolled in the study. Following laboratory tests will be performed to assess

the safety of the investigational product.

• CBC

• Liver Profile

• Lipid Profile

• Kidney Profile

• Fasting Blood sugar

• Urine analysis

• Pregnancy test

Subjects will be assessed at screening and at the end of the study to know the

safety of the product. During these visits all the above tests will be performed

except pregnancy test at screening.

Subjects who are eligible for the study will be enrolled in the study. Subjects

will be asked to take ‘Sleep/well’ capsule an hour before going to bed.

Subjects will be provided a diary to document every morning regarding their

experience about sleep within 60 minutes from the consumption of the

capsules, whether feeling groggy in the morning and more energized (no

drowsiness) after waking up and better sleep quality through the night.

Subjects will be assessed by Pittsburgh Sleep Quality Instrument (PSQI)

score during screening and end of the study.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-21
• Study Completion: 2023-02-01
• Last Update Posted: 2023-12-01

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 90

Inclusion Criteria

• Female participants with Age between 25-40 years.
• Females facing problems while initiating or maintaining sleep.
• Willing to participate in the study after informed consent.
• Pittsburgh Sleep Quality Instrument score higher than 5.

Exclusion Criteria

• Current use of prescribed or over-the-counter sleep medications.
• Pregnant or lactating mother.
• Current unusual or highly unstable sleep schedule 4.
• Trans-meridian travel across more than three time zones within 4 weeks prior to study entry.
• Significant and uncontrolled major illness or psychiatric disease 6.
• Current life stress.
• Use of tobacco within 6 months prior to study entry 8.
• Excessive use of alcohol or caffeine.
• Currently taking hormone replacement therapy hypnotic or psychotropic medication.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in sleep latency.	Visit 1 visit 2
Improvement in sleep quality	Visit 1 visit 2

Secondary Outcome Measures

Name	Time	Method
Improvement in sleep quality	Visit 1 visit 2

Trial Locations

Locations (1)

Spectrum Health Care; 🇮🇳 Mumbai, MAHARASHTRA, India

Spectrum Health Care

🇮🇳Mumbai, MAHARASHTRA, India

Dr Astrid Velho

Principal investigator

022-68428800

avelho@spectrumhealthcare.co.in