A comparative study on human healthy volunteers with Sleep problems

Completed

Conditions: with sleep disturbances

Registration Number: CTRI/2022/05/042818

Lead Sponsor: OmniActive Health Technologies

Brief Summary: This is a randomized,double-blind, parallel, placebo-controlled, clinical interventional study.Adult healthy males and/or females with sleep complaints, aged between 18 and 50years and meeting all inclusion and no exclusion criteria will be enrolled inthe study after signing a written informed consent. Clinical assessmentswill include questionnaire based assessments, wrist actigraphy ,polysomnography and Epworth Sleepiness Scale .There will be 3follow-up visits at Day 3, Day 14 and Day 28 followed by End of study visit on Day 56. Safety assessments will include monitoringof Adverse Events (AEs), physical examination, vital signs measurement, UrinePregnancy Tests (for females of childbearing potential), Hematology andclinical chemistry tests.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 80

Inclusion Criteria

1.BMI of 18.5 kg/m2 to 29.9 kg/m2 (both limits inclusive) 2.Pittsburgh sleep quality index (PSQI) score of 5 and above 3.Insomnia Severity Index (ISI) score of 14 and below 4.Beck Anxiety Inventory (BAI) score of 15 and below 5.Subjects who agree to maintain their usual level of activity throughout the trial period and willing to refrain from vigorous physical activity within 2 hours of bedtime.
6.Subjects who agree to maintain their usual dietary habits and level of exercise i.e. maintain their usual life-style throughout the trial period.
7.Subjects willing to consume the study product 30 minutes before bed throughout the study period.
8.Subjects willing to refrain from taking any medications or preparations to improve sleep (herbal, dietary supplements, homeopathic preparations, etc.) during the study 9.Subjects willing to consume no more than 4 servings of caffeine substances per day and no caffeine within 6 hours of bedtime.
10.Subjects who agree to stay weight stable during the study period.
11.Female subjects of child bearing potential practicing an acceptable method of birth control such as Intrauterine Device in place for at least 3 months prior to the start of the study and remaining in place during the study period, contraceptive transdermal, injection or implants, non-hormonal or hormonal, abstinence: Subjects who shall be practicing abstinence shall agree to have a documented second acceptable method of birth control should the subject become sexually active during the course of her study participation for the duration of the study as judged by the investigator(s)/study physician and agree to follow the same should be used during treatment.
OR Postmenopausal for at least 1 year.
OR Surgically sterile (bilateral tubal ligation/bilateral oophorectomy/hysterectomy has been performed on the subject).
12.Subjects willing to provide written consent.
13.Subjects shall be willing and able to understand and comply with the requirements of the study, consume the study IP as instructed, return for the required treatment period visits, comply with therapy prohibitions, and be able to complete the study.

Exclusion Criteria

1.Having hypersensitivity or history of allergy to the study product.
2.Subjects with a malignant disease or any concomitant end- state organ disease and/or laboratory abnormalities considered by investigators to be risky or that could interfere with data collection 3.Subjects suffering from a metabolic disorder (uncontrolled diabetes, uncontrolled thyroidal condition) and/or from severe chronic disease (cancer, renal failure, HIV, immunodeficiency, hepatic or biliary disorders, arthritis, uncontrolled cardiac disease) or from a disease found to be inconsistent with the conduct of the study by the investigator.
4.Subjects with a psychiatric diagnosis other than anxiety or depression.
5.Subjects with uncontrolled hypertension (systolic blood pressure >160 mm Hg or diastolic blood pressure >100 mm Hg) at screening.
6.Subjects who are on anxiolytics, anti-depressants, antipsychotics, anticonvulsants, centrally acting corticosteroids, opioid pain relievers, hypnotics, and/or prescribed sleep medications.
7.Subject has a history of unconventional sleep patterns (e.g., night shift), chronic insomnia (defined as insomnia at least 3 days/week over the past month), a diagnosed sleep disorder (e.g., OSA), or a chronic medical condition that may impact energy/fatigue levels, in the judgment of the investigator 8.Subjects with a history of drug and /or alcohol abuse at the time of enrolment 9.Subjects who are pregnant, nursing, or planning a pregnancy within the study participation period.
10.Subjects with positive Urine Pregnancy Test at Screening/Randomization Visit.
11.Subjects who have been treated with any investigational drug or investigational device within a period of 3 months prior to study entry.
12.Any additional condition(s) that in the Investigators opinion would warrant exclusion from the study or prevent the subject from completing the study.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Sleep Quality Index and Sleep Latency compared to Placebo	Day 0, Day 3, Day 14, Day 28, Day 56

Secondary Outcome Measures

Name	Time	Method
Change in Actigraphy based assessment parameters	Day 0, Day 3, Day 14, Day 28, Day 56
Change in Questionnaire based assessments	Day 0, Day 3, Day 14, Day 28, Day 56
Change in Epworth Sleepiness Scale	Day 0, Day 3, Day 14, Day 28, Day 56
Change in Polysomnography based assessment parameters	Day 0, Day 56

Trial Locations

Locations (1): BGS Global Institute of Medical Sciences
🇮🇳
Bangalore, KARNATAKA, India
BGS Global Institute of Medical Sciences
🇮🇳Bangalore, KARNATAKA, India
Dr Harshith C S
Principal investigator
9482164779
harsh0594@gmail.com