perimenopausal stable angina pectoris with insomnia acupuncture, perimenopausal stable angina pectoris, insomnia, RCT
Conditions
Interventions
In the study, the acupuncture needles of 0.30mm in diameter and 40mm in length (Suzhou Hualun Medical Appliance Co, Ltd, Suzhou, China) will be used. All acupuncture points are identified according to
acupuncture manipulation is applied to point for numbness,swelling, pain, soreness, and other Deqi sensations
the needles are maintained for 25minutes for each session
manual rotational stimulation 1 times every 2 minutes.,The sham acupuncture group will use blunt-tipped placebo needles (0.30mm in diameter and 40mm in length, manufactured by Suzhou Hualun Medical Ap
Experimental Other,Placebo Comparator Other
Sponsors
Changchun University of Chinese Medicine
Eligibility
Sex/Gender
Female
Age
40 Years to 65 Years
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| insomnia baseline, 4, 8, 12 weeks.1, 3, 6 months (follow-up period) Pittsburgh Sleep Quality Index | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
China
Contacts
Public ContactTian TengHui
Affiliated Hospital of Changchun University of Chinese Medicine
Outcome results
None listed