Clinical Study on â??SHL 1047â?? Tablet in Primary Insomnia.

Phase 2

• Conditions: Health Condition 1: G470- Insomnia

• Registration Number: CTRI/2018/04/013035
• Lead Sponsor: SAVESTA LIFESCIENCES INC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

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

Inclusion Criteria

1) Participants aged greater than or equal to 21 and less than 65 years at the time of obtaining written informed consent

2)Participants diagnosed with primary insomnia based on the Diagnostic and Statistical Manual of Mental Disorders, text revision (DSM-IV-TR)

3)Insomnia Severity Index more than 7 and less than 21

4)Subjects willing to sign inform consent form

5)A female participant who is of reproductive potential has a negative pregnancy test and agrees to use contraception throughout study period

6)Willing to limit alcohol, caffeine, and nicotine consumption while in the study

Exclusion Criteria

1)History or diagnosis of another sleep disorder

2)Difficulty sleeping due to a medical condition

3)History of a neurological disorder

4)History of bipolar disorder, psychotic disorder, or posttraumatic stress disorder, or current psychiatric disorder that requires medication

5)On-going depression and generalized anxiety disorder (diagnosis on PHQ 9 and GAD 7 score scales)

6)History of substance abuse or dependence

7)History or current evidence of a clinically significant cardiovascular disorder or clinically significant electrocardiogram (ECG) at Pre study Visit

8)Taking certain prohibited medications

9)Subjects with habit of smoking Cigarette etc.

10)Subjects with known history of hepatitis B and/ or C

11)History of malignancy less than or equal to 5 years prior to signing informed consent

12)Known hypersensitivity to any of the ingredients of â??SHL 1047â??

13)Other conditions, which in the opinion of the investigators, makes the patient unsuitable for enrolment or could interfere with his/her participation in, and completion of the protocol

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Change in patient-reported total sleep time (as per patient diary) compared between â??SHL 1047â?? and Placebo at every visit till the end of the study. <br/ ><br>2.Change in sleep efficiency (derived from patient diary) compared between â??SHL 1047â?? and Placebo at every visit till the end of the study. <br/ ><br>Timepoint: Screening Visit (up to Day -14), Baseline Visit (Day 0), Visit 1 (Day 7), Visit 2 (Day 14), Visit 3 (Day 21), Visit 4 (Day 28), Visit 5 (Day 35)

Secondary Outcome Measures

Name	Time	Method
1.Change in patient-reported time to sleep onset, number of awakenings, wake time after sleep onset, <br/ ><br>2.Change in severity of Insomnia, daytime fatigue <br/ ><br>3.Change in daytime mood, ability to function at work, concentration, memory and quality of sleep <br/ ><br>4.Assessment of rebound insomnia <br/ ><br>5.Global assessment for overall improvement by investigator and by patient. <br/ ><br>6.Assessment of vitals, adverse events, laboratory parameters <br/ ><br>Timepoint: Screening Visit (up to Day -14), Baseline Visit (Day 0), Visit 1 (Day 7), Visit 2 (Day 14), Visit 3 (Day 21), Visit 4 (Day 28), Visit 5 (Day 35)