Clinical study to compare effectiveness of ayurvedic medicine with ayurvedic procedure in primary insomnia.

Phase 2

• Conditions: Health Condition 1: F510- Insomnia not due to a substance orknown physiological condition

• Registration Number: CTRI/2022/08/044736
• Lead Sponsor: State Ayurvedic College and Hospital Lucknow

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1)Individuals between the age group of 21 to 60 years of both sexes having insomnia of minimum one month duration will be selected randomly for the study.

2)Patients complaining of disturbed sleep with Athens insomnia scale (AIS) score >= 6

Exclusion Criteria

ï?¶ Patients below 21 years and above 60 years of age.

ï?¶ Pregnant lady and lactating mother.

ï?¶ Patients with major psychiatric illness like schizophrenia, depressive psychosis, epilepsy

etc will not registered.

ï?¶ Patients with alcohol dependency or drug dependency will excluded from the study.

ï?¶ Patients having chronic illness like asthma, malignancies, liver cirrhosis, chronic renal

failure, uncontrolled diabetes and Hypertension etc. will be excluded.

ï?¶ Patients with acute illness like Congestive Cardiac Failure, Myocardial Infarction,

Chronic Obstructive Pulmonary Disorders, meningitis, acute pain conditions and similar

other disorders will be excluded.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical outcome assessment among the people registered under the study will be done through <br/ ><br>1.Athens Insomnia Scale <br/ ><br>(AIS) Score â?¥ 6 <br/ ><br>Nidranasha Angmarda,Shirogaurav,Jrimbha,Tandra,Bhrama,Apaki <br/ ><br>All the signs and symptoms are graded 0,1,2,3 on basis of intensity confirmed by clinical examination before trial.The clinical improvement during and after trial will also be correlated and assess with previous grading.Timepoint: 8 weeks.

Secondary Outcome Measures

Name	Time	Method
Quality of life improvement.Timepoint: 8 weeks.