Acupuncture for perimenopausal stable angina pectoris with insomnia: A protocol for randomized, double-blind, placebo-controlled trial research

Phase 1

• Conditions: perimenopausal stable angina pectoris with insomnia; acupuncture, perimenopausal stable angina pectoris, insomnia, RCT

• Registration Number: TCTR20221121001
• Lead Sponsor: Changchun University of Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-21
• Study Completion: 2023-12-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: Female
• Target Recruitment: 110

Inclusion Criteria

1.Meet the diagnostic criteria for SAP and insomnia as described above;
2.Women over 40 years old and in perimenopause;
3.Do not receiving acupuncture for at least 6 months;
4.Agree to participate in the study and be randomly assigned to any group.

Exclusion Criteria

1.Patients with non-normal menopause;
2.Patients with Severe renal, hepatic, hematologic, and other systemic diseases;
3.Patients with psychiatric disorders or consciousness;
4.Patients with uncontrollable severe hypertension or diabetes mellitus, or malignant arrhythmia;
5.Patients with acute myocardial infarction,unstable angina,hypertrophic cardiomyopathy, valvular heart disease,myocarditis,severe heart failure after cardiac pacemaker implantation;
6.There are surgery, trauma, bleeding, and severe infection in the past 3 months;
7.Insomnia caused by drugs, alcohol , or environmental changes;
8.Skin infection near designated acupoints;
9.Patients with malignant tumors, hyperthyroidism;
10.Syncope or serious fear of blood during acupuncture;
11.Any other factors that, in the investigator's opinion, may make the patient unable to complete or unsuitable for the clinical research.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
insomnia baseline, 4, 8, 12 weeks.1, 3, 6 months (follow-up period) Pittsburgh Sleep Quality Index

Secondary Outcome Measures

Name	Time	Method
insomnia baseline, 4, 8, and 12 weeks sleep parameters,the MOS item short-form health survey,sleeping pill dosage,Hamilton Depression Scale,Generalized Anxiety Disorder Scale,stable angina pectoris baseline, 4, 8, and 12 weeks SAP blood parameters,Seattle Angina Scale