Zolsoma Tablet in Sleep Disorder

Phase 4

Conditions: Health Condition 1: G998- Other specified disorders of nervous system in diseases classified elsewhere

Registration Number: CTRI/2021/10/037106

Lead Sponsor: Pulse Pharmaceuticals Pvt Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1.Patients of either gender of age 18 years and above.

2.Patients visiting Psychiatry opd with complaints of co-morbid disorders.

3.A history of daytime complaints associated with disturbed sleep.

4.Patients are required to have language competency to respond to study related questionnaires including Pittsburgh Sleep Quality Index, Insomnia Severity Index and Epworth Sleepiness Scale to measure the quality of sleep and sleep latency.

5.Patients with self-reported sleep disturbances.

6.Patients with normal medical history and a record of Physical Examination, Lab Tests are included.

7.Women of childbearing potential are required to receive a highly effective form of contraception.

8.Subjects willing to sign the Informed Consent Form.

9.Subject or legally acceptable representative (LAR) is able to attend all scheduled visits and to comply with the trial protocol.

Exclusion Criteria

1.Patients who have consumed any sedative (Benzodiazepine/ Baribiturate) one week prior to the initiation of the study.

2.Subjects with history of substance abuse except nicotine use.

3.Patients with known hypersensitivity or any contraindications to the use of any study medication.

4.Patients with chronic illness that might interfere with the trial completion or conduct.

5.Pregnant women & lactating mothers & women intending pregnancy.

6.Subject who is identified as a natural or adopted child of the investigator, relatives or employee with direct involvement in the proposed study.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To document any adverse events associated with the use of Zolsoma tablets. <br/ ><br> <br/ ><br>To evaluate day-time sleepiness using Epworth Sleepiness Scale <br/ ><br>Timepoint: Time Frame: Baseline and Day 30Ã?Â±2

Secondary Outcome Measures

Name	Time	Method
Measurement of quality of sleep and sleep latency using Pittsburgh Sleep Quality index. <br/ ><br> <br/ ><br>To determine the changes in the severity of insomnia by using Insomnia Severity IndexTimepoint: [Time Frame: Baseline and Day 30Ã?Â±2]