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

A Double-Blind Placebo Controlled Clinical Trial to evaluate safety and efficacy of SLP-04 in individuals with mildly / moderately compromised alertness, energy, concentration, and behavioral integrity due to suboptimal Sleep Quality

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2022/09/045604

Enrollment

Registered

2022-09-16

Start date

Unknown

Completion date

Unknown

Last updated

2022-10-17

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

Conditions

None listed

Interventions

Intervention1: Product SLP-04 is intended to support in mild to moderate compromise in alertness, energy, concentration, and behavioral integrity due to suboptimal Sleep quality: As per the randomizat

Eligibility

Inclusion criteria

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. SubjectÃ¢â?¬•s complete blood count parameters to be within clinically acceptable range by Investigator.

Exclusion criteria

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 patientÃ¢â?¬•s inclusion for the study. 8. Subjects with underlying heart conditions 9. Night Shift workers affecting sleep 10. Subjects who are on medications Ã¢â?¬â?? Sedatives, Antidepressants, stimulants, decongestants, narcotic analgesics, cardiovascular, pulmonary 11. Chronic alcoholic affecting sleep assessment

Design outcomes

Primary

Measure	Time frame
Ã¢â?¬Â¢Change in sleep quality and pattern as assessed using LSEQ sleep Evaluation questionnaireTimepoint: after 30 days of treatment	—

Secondary

Measure	Time frame
a. Changes in scores of WHO-5 Well-Being Index b. Change in clinical parameters c. Change in SF-12v2 Health survey d. To study the changes in the sleep quality by wearable watch e. Changes in the sleep quality as assessed by Sleep Diary f. Incidence of adverse events as reported by subject or assessed by evaluator g. Laboratory findings for safety assessment 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)	—

Measure

Time frame

a. Changes in scores of WHO-5 Well-Being Index b. Change in clinical parameters c. Change in SF-12v2 Health survey d. To study the changes in the sleep quality by wearable watch e. Changes in the sleep quality as assessed by Sleep Diary f. Incidence of adverse events as reported by subject or assessed by evaluator g. Laboratory findings for safety assessment 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)

—

Countries

India

Contacts

Public ContactDr Palaniyamma Durairaj MBBS MD

Amway Global Services India Pvt ltd.

palaniyamma.durairaj@amway.com686681830

Outcome results