Clinical Trial of Sleepnite Tablet in patients suffering from Insomnia

Phase 3

Conditions: Health Condition 1: G470- Insomnia

Registration Number: CTRI/2022/09/045737

Lead Sponsor: Meyer Organics Pvt Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1. Participants aged greater than or equal to 18 and less than or equal to 65 years of both sex at the time of obtaining written informed consent;

2. Participants diagnosed with insomnia disorder based on the Diagnostic and Statistical Manual of Mental Disorders, text revision (DSM-V-TR);

3. Insomnia Severity Index more than 7 and < 21 i.e. mild to moderate;

4. Patients with a diagnosis of Mild or moderate depression (Patients’ health questionnaire (PHQ-9) score of =14);

5. Patients with a diagnosis of Mild or moderate Generalized anxiety disorder (Generalized anxiety disorder (GAD) -7 questionnaire score of =10);

6. Subjects willing to sign inform consent form;

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

8. No history of substance use disorder other than use of nicotine and recreational use of alcohol (not having used for the last 14 days and consenting not to use the same during the period of the trial);

9. Willing to limit caffeine consumption while in the study.

Exclusion Criteria

1. Difficulty sleeping due to a medical condition;

2. History of a neurological disorder;

3. Lifetime history of severe mental illness;

4. History of bipolar disorder, psychotic disorder, or posttraumatic stress disorder, or current psychiatric disorder that requires sedating medication;

5. On-going depression and generalized anxiety disorder (diagnosis on PHQ 9 score =15 and GAD 7 score =11 scales);

6. History of substance abuse or dependence;

7. History or current evidence of a clinically significant cardiovascular disorder at pre study visit;

8. Taking certain prohibited medications;

9. Consumption of >15 cigarettes a day;

10. History of malignancy =5 years prior to signing informed consent;

11. Known hypersensitivity to any of the ingredients of Sleepnite tablet;

12. 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.