A study to evaluate the efficacy and safety of Investigational Product SLEPOVIN in patients with Insomnia

Not Applicable

Completed

• Conditions: Health Condition 1: F01-F99- Mental, Behavioral and Neurodevelopmental disorders

• Registration Number: CTRI/2019/05/019431
• Lead Sponsor: BigBrother Nutra Care Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2019-08-21
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

1. Male or female subjects aged above 18 years old (inclusive)

2. Subject is in good physical status and mental health

3. Male or female subjects aged above 18 years old (inclusive)

4.Subject is in good physical status and mental health

5. Sleep onset insomnia (difficulty taking sleep at the beginning of the night)

6. Sleep maintenance insomnia (difficulty in maintaining the sleep)

7. Nocturnal awakenings, difficulty in retuning to sleep after awakening in the middle of the night or wakening early in the morning

8. Insomnia severity index > 7

9. Subject is willing to limit alcohol, caffeine, and nicotine consumption while in the study

10. Habitual bedtime between 8.30 pm and midnight

11. Able and willing to follow all study related instructions and to complete all required visits

12. Subjects willing to give inform consent for participation

Exclusion Criteria

1. Subjects with clinically significant endocrine, metabolic, hepatic, renal, cardiovascular, gastrointestinal, respiratory, hematological or neurological illness (es)

2. History of bipolar disorder, psychotic disorder, or posttraumatic stress disorder, or current psychiatric disorder that requires a prohibited medication

3. Subjects who suffer from sleep disorder other than primary insomnia including restless leg syndrome and sleep apnea

4. Subjects with substance dependence/ abuse in the past one year or with alcohol abuse are ineligible

5. Subjects taking certain prohibited medications

6. Females who are pregnant, lactating or likely to become pregnant during the study

7. Subjects using tobacco products or caffeinated beverages during night awakenings.

8. Clinical history of allergy/ hypersensitivity to one or more products of herbal origin. Is currently participating or has participated in another interventional clinical study at this or any other facility in the past 3 month

Study & Design

• Study Type: Interventional
• Study Design: Not specified