Effects of acupuncture for pre & stage 1 hypertension in postmenopausal wome

Not Applicable

Completed

• Conditions: Diseases of the circulatory system

• Registration Number: KCT0000771
• Lead Sponsor: Korea Institute of Oriental Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 11 March 2019

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

1. Females aged 45 to 65.
2. Subjects whose menstruation has ended one year or longer before and whose follicle-stimulation hormone concentration is over 40 mIU/mL.
3 Subjects whose sitting blood pressure values measured from the selected arm during screening are in the pre or stage 1 hypertension (120= systolic blood pressure =159 mmHg or 80= diastolic blood pressure =99 mmHg).
4. Those who consent to participate in this trial and sign an informed consent statement after listening to a clear explanation of the purpose and characteristics of this clinical trial.

Exclusion Criteria

1. Subjects who have taken antihypertensive drugs within the past 3 months.
2. Subjects who have taken herbal medicine or functional food used for involutional disorder symptoms within the recent three months.
3. Subjects who have received hormone therapy such as estrogen or progestin within the recent one month.
4. Subjects whose blood pressure difference measured from the selected arm during screening is systolic blood pressure =20 mmHg or diastolic blood pressure =10 mmHg.
5. Subjects who have a history of secondary blood pressure or are suspected of secondary blood pressure(for example, coarctation of aorta, renal artery stenosis, primary aldosteronism, pheochromocytoma, Cushing’s syndrome, polycystic renal disease, hyperthyroidism(thyroid stimulating hormone <0.35 uIU/ml, free thyroxine =1.76 ng/dl).
6. Subjects who have orthostatic hypotension accompanying symptoms.
7. Subjects who have uncontrollable diabetes mellitus.
8. Subjects who have severe heart disease: those who have suffered from ischemic heart disease during the recent six months (angina pectoris, myocardial infarction) or who have undergone peripheral vascular disease, percutaneous transluminal coronary angioplasty or coronary artery bypass graft.
9. Subjects who have on electrocardiogram clinically significant ventricular tachycardia, atrial fibrillation, atrial flutter, or other arrhythmia judged by the examiner as significant.
10. Subjects who have hypertrophic obstructive cardiomyopathy, severe obstructive coronary artery disease, aortostenosis, or hemodynamically significant aortic or mitral valve stricture.
11. Subjects with severe cerebrovascular disease: those who have had cerebral infarction or cerberal hemorrhage within the recent six months.
12. Subjects with known moderate or malignant retinosis: those who have had retinal haemorrhage, visual disturbance, or retinal microaneurysm within the recent six months.
13. Subjects with consumptive disease(tuberculosis, malignant tumors) or autoimmune disease(systemic lupus erythematosus, rheumatoid arthritis, dermatomyositis, systemic sclerosis, or thyroiditis).
14. Subjects who have clinically significant kidney or liver disease or have a finding on hematological test of creatinine level being 1.5 mg/dl or higher and alanine aminotransferase and aspartate aminotransferase levels being above 2.5 times as high as the normal upper limit.
15. Subjects who have a history of drug or alcohol abuse or suspected so.
16. Subjects who have chronic inflammatory conditions that require chronic anti-inflammatory treatment.
17. Subjects who are participating in other clinical trials.
18. Subjects who are inmates at group facilities, such as social welfare institutions.
19. Subjects who do not provide informed consent.
20. Others whose clinical trials conductors are considered inappropriate for participating in this trial.

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
the amounts of changes in diastolic blood pressure levels at four weeks after the random assignment

Secondary Outcome Measures

Name	Time	Method
the amounts of changes in diastolic blood pressure levels at 8, 16, and 20 weeks after the random assignment;the amounts of changes in systolic blood pressure levels at 4,8,16, and 20 weeks after the random assignment;blood pressure control rates;Lipid profiles;High sensitivity c-reactive protein(hs-CRP)