Pharmacological and Phytochemical Study of Upodika in Insomnia

Phase 2

• Conditions: Health Condition 1: G470- Insomnia

• Registration Number: CTRI/2022/03/041312
• Lead Sponsor: Ayurvedic and Unani Tibbia College and Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

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

Inclusion Criteria

1. Both sexes patients of age group between 20 to 60 years.

2. Patients with complaints of primary insomnia. 3. Patients who are willing to participate and give written informed consent.

4. Patients suffering from following type of disturbed sleep pattern. (a)Sleep onset insomnia (Difficulty taking sleep at the beginning of the night) (b)Sleep maintenance insomnia (Difficulty maintain the sleep) (c)Nocturnal awakenings (Difficulty to returning to sleep after awakening inthe middle of the night or wakening early in the morning) (d)Patients having insomnia more than 1 month

Exclusion Criteria

1. Secondary insomnia and patients suffering from fatal familial insomnia.

2. Patients on hypnotic medicine or other drugs known to cause drowsiness.

3. Patients suffering from congenital anomalies 4. DM, HTN and other serious cardiovascular disorders.

5. Hereditary Disease

6. Taking treatment for major psychiatric disorders.

7. Subjects on systemic or oral steroids.

8. Patients with alcohol or drug dependency.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Insomnia Severity Index: <br/ ><br>The ISI is a self-report instrument measuring respondentsâ?? perception of both nocturnal and diurnal symptoms of insomnia. The ISI comprises 7 items assessing the perceived severity of <br/ ><br>difficulties initiating sleep, staying asleep, early morning awakenings, satisfaction with current sleep pattern, interference with daily functioning, noticeability of impairment attributed to the sleep problem, and degree of distress or concern caused by the sleep problem. The ISI has good psychometric properties and is sensitive to treatment in clinical trials.Timepoint: 3 months

Secondary Outcome Measures

Name	Time	Method
The Pittsburgh Sleep Quality Index (PSQI) <br/ ><br>The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances. Different individual items generate seven component scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The sum of scores for these seven components yields one global score. <br/ ><br>Timepoint: 3 months