Post Marketing Study of Cannaease Vijaya Tinctures(Sleep Well 10%) in patients with Insomnia

Phase 4

Completed

• Conditions: Health Condition 1: G470- Insomnia

• Registration Number: CTRI/2022/04/042211
• Lead Sponsor: Ananta Hempworks Solutions Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2023-03-30
• Last Update Posted: 1 May 2023

Recruitment & Eligibility

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

Inclusion Criteria

1.Provide informed consent prior to any study specific assessments being performed

2.Between 18 and 60 years old, inclusively

3.Insomnia as defined by an ISI score of 8 or above

4.Insomnia symptoms for at least 3 months or less than 6.5 hours of sleep per night

5. Resident of India and currently living in the India for the duration of the trial

Exclusion Criteria

1. Presence of an active and progressive physical illness (e.g.,

congestive-heart failure, chronic obstructive pulmonary

disease, acute pain), neurological disorder (e.g., epilepsy) or

neurological degenerative diseases (e.g., dementia, multiple

sclerosis)

2. Unstable medication regimen (change to schedule or dosage

within the past 3 months)

3. Diagnosis of a psychotic disorder or bipolar disorder or

medical condition contraindicated by sleep restriction

4. Have family or work schedules that prevent them from having

normal sleep schedules defined as bedtime between 8:00 pm

and 2:00 am and/or waking times between 4:00 am and 10:00

am.

5. Individuals who need to be alert or cautious to avoid serious

accidents in their job or daily life. Examples include: Long-

haul truck drivers, Long-distance bus drivers, Air traffic

controllers, Operators of heavy machinery, some assembly line

jobs.

6. Pregnant or planning to become pregnant during the course of

the trial.

7. Other untreated sleep disorders as self-reported by the

participant (e.g., obstructive sleep apnea, periodic leg

movements, parasomnias)

8. Participated in an investigational research study in the past 30

days

Study & Design

• Study Type: PMS
• Study Design: Not specified