Tagaradi Capsule in insomnia

Phase 1

Completed

• Conditions: Health Condition 1: F489- Nonpsychotic mental disorder, unspecifiedHealth Condition 2: null- patients suffering from insomnia

• Registration Number: CTRI/2017/03/008084
• Lead Sponsor: IPGT RA GAU Jamnagar

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2019-12-27
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 100

Inclusion Criteria

1. Patients of both sexes in between the age group 18-75 years.

2. Patients suffering from following type of disturbed sleep pattern.

1) Sleep onset insomnia (Difficulty to taking sleep at the beginning of the night)

2) Sleep maintenance insomnia (Difficulty to maintain the sleep)

3) Nocturnal awakening (Difficulty to returning to sleep after awakening in the middle of the night or wakening early in the morning)

4) Rebound insomnia (Patients who has developed dependence to sedatives)

5) Circadian rhythm disorders (Sleeping pattern changes)

6) Patients having insomnia more than 2 weeks, less than 6 months

3. Patients of insomnia with mild hypertension, mild depression and anxiety disorders without any complains of other major diseases.

Exclusion Criteria

•Patients less than 18 years and more than 75 years.

•Patients suffering from fatal familial insomnia.

•Insomnia with major psychiatric illness like, Schizophrenia, Depressive psychosis, Epilepsy, etc.

•Patients having advanced chronic illness like Bronchial asthma, Diabetes mellitus, Malignancy, Liver cirrhosis, Chronic renal failure, etc.

•Patients with alcohol or drug dependency will be excluded.

•Patients having acute illness like Cardiovascular accidents, Myocardial infarction, Chronic obstructive pulmonary disease.

•Pregnant woman and planning to be pregnant within six months.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
relief in signs and symptoms of Anidra (Insomnia)Timepoint: 8 weeks

Secondary Outcome Measures

Name	Time	Method
relief in signs and symptoms of Anidra (Insomnia) and regular normal sleepTimepoint: 8 weeks