Clinical study on Tulsi OdaatÂ® Capsule in Sleep Disorder

Phase 2

Completed

Conditions: Health Condition 1: G470- Insomnia

Registration Number: CTRI/2020/11/028939

Lead Sponsor: ODAAT PHARMA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 31

Inclusion Criteria

1.Subjects diagnosed with Insomnia Disorder based on DSM-5 Diagnostic Criteria for Insomnia Disorder

2.Insomnia Severity Index more than 7 and less than 21

3.Subjects willing to sign inform consent form

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

5.Willing to stop alcohol, caffeine, and nicotine consumption while in the study

Exclusion Criteria

1.History or diagnosis of any other disease resulting in another sleep disorder

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

3.On-going depression and generalized anxiety disorder

4.History of substance abuse or dependence

5.History or current evidence of a clinically significant cardiovascular disorder or clinically significant electrocardiogram (ECG) at screening visit

6.Taking prohibited medications [opium, cannabis (marijuana) and methamphetamines]

7.Subjects with habit of smoking

8.Subjects with known history of hepatitis B and/ or C

9.History of malignancy <=5 years prior to study participation

10.Known hypersensitivity to any of the ingredients of â??Tulsi OdaatÂ® Capsuleâ??

11.Any other condition due to which patients are deemed to be unsuitable by the investigator for reason(s) not specifically started in the exclusion criteria

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) <br/ ><br>2.Change in sleep efficiency <br/ ><br>Timepoint: Day-3, Day 0, Day 14, Day 28, Day 35

Secondary Outcome Measures

Name	Time	Method
1.Change in patient-reported time to sleep onset, number of awakenings and WASO <br/ ><br>2.Requirement of sedatives as rescue medication <br/ ><br>3.Change in severity of Insomnia <br/ ><br>4.Changes in daytime fatigue, mood, ability to function at work, concentration and memory <br/ ><br>5.Assessment of Quality of sleep on PSQI and rebound of insomnia <br/ ><br>6.Global assessment for overall change by investigator and by patient <br/ ><br>7.Assessment of tolerability of study drug, adverse events, vitals and safety lab parameters <br/ ><br>Timepoint: Day-3, Day 0, Day 14, Day 28, Day 35