Clinical study to evaluate a polyherbal product in individuals with compromised alertness, energy, concentration, and behavioral integrity due to suboptimal Sleep Quality.

Phase 4

• Registration Number: CTRI/2022/09/045604
• Lead Sponsor: Amway Global Services India Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Men and women aged over 20-55 years, both inclusive.

2. Subjects with mild to moderate compromise in alertness, energy, concentration, and behavioral integrity due to suboptimal Sleep quality evaluated by LSEQ sleep assessment questionnaire (30 mm to 60 mm in a VAS scale of 0 to 100 mm) for the last 1 month

3. Subjects with regular sleep wake cycle- fixed sleep pattern and absence of sleep apnea

4. Able and willing to follow all study related instructions.

5. Must be willing to give written informed consent and comply with the study procedures.

6. Subjectââ?¬•s complete blood count parameters to be within clinically acceptable range by Investigator.

Exclusion Criteria

1. Pregnant and Breast-feeding Women will be excluded.

2. On-going treatment on managing stress levels/ sleep disorders.

3. Severe psychiatric disorders, severe episodes of anxiety disorders, post-traumatic stress disorder

4. Subjects presenting with severe continuous stress levels in the last 3 months

5. Systemic disorders, undergone surgeries, on medications, endocrinal disorders

6. History of having received any investigational drug or participated in any other clinical trial which ended in the preceding three months or currently ongoing.

7. Any condition that in the opinion of the investigator does not justify the patientââ?¬•s inclusion for the study.

8. Subjects with underlying heart conditions

9. Night Shift workers affecting sleep

10. Subjects who are on medications ââ?¬â?? Sedatives, Antidepressants, stimulants, decongestants, narcotic analgesics, cardiovascular, pulmonary

11. Chronic alcoholic affecting sleep assessment

Study & Design

• Study Type: PMS
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
�Change in sleep quality and pattern as assessed using LSEQ sleep Evaluation questionnaireTimepoint: after 30 days of treatment

Secondary Outcome Measures

Name	Time	Method
a.Changes in scores of WHO-5 Well-Being Index <br/ ><br>b.Change in clinical parameters <br/ ><br>c.Change in SF-12v2 Health survey <br/ ><br>d.To study the changes in the sleep quality by wearable watch <br/ ><br>e.Changes in the sleep quality as assessed by Sleep Diary <br/ ><br>f.Incidence of adverse events as reported by subject or assessed by evaluator <br/ ><br>g.Laboratory findings for safety assessment <br/ ><br>Timepoint: Clinical evaluation of the subject at day 1, 10, 24 and Day 31 and lab investigation at screening and Day 31 (End of the study)