Comparison of the effects of Dracocephalum and Rosa Damascene capsule on sleep disorder in heart failure patients

Phase 2

• Conditions: Condition 1: Sleep disorder. Condition 2: Heart failure.; Heart failure; Other sleep disorders not due to a substance or known physiological condition; F51.8

• Registration Number: IRCT20240316061309N1
• Lead Sponsor: Kashan University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 27 May 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Definitive diagnosis of heart failure with echo based on EF less than or equal to 40%
confirmation of cardiologist
Having a sleep disorder with a score of 5 or more from the Petersburg sleep disorder instrument despite taking sedatives
Desire and informed consent of the patient

Exclusion Criteria

The client's unwillingness to continue cooperation at any time of the study
use of complementary therapies or other drugs affecting sleep concurrently without coordination during the study
The occurrence of acute problems leads to changes in the treatment process and the death of the patient

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sleep disorder. Timepoint: In the pre-intervention period, one day after the first dose, the eighth day after the administration. Method of measurement: Petersburg Sleep Disorder Questionnaire.

Secondary Outcome Measures

Name	Time	Method
Anxiety. Timepoint: In the pre-intervention period, one day after the first dose, the eighth day after the administration. Method of measurement: Spielberger anxiety questionnaire.