None listed
Conditions
Interventions
Medical Device : The participants assigned to the treatment group will receive acupuncture treatment at 5 acupuncture points (PC6, SP4, LR3, LI11, ST36), 2-3 times per week for 4 weeks (a total of 10
Sponsors
Korea Institute of Oriental Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female aged 20-65 years old. 2. Subjects whose sitting blood pressure values measured from the selected arm during screening are in the pre or stage 1 hypertension. 3. 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
Exclusion criteria: 1. Subjects whose blood pressure measured during screening is systolic blood pressure =160 mmHg or diastolic blood pressure =100 mmHg. 2. Subjects whose blood pressure difference measured from the selected arm during screening is systolic blood pressure >20 mmHg or diastolic blood pressure >10 mmHg. 3. Subjects who have taken herbal medicine or functional food or antihypertensive drugs regularly to control blood pressure within the past 6 months. 4. Subjects who have a history of secondary blood pressure or are suspected of secondary blood pressure. 5. Subjects who take medications which may affect blood pressure such as oral anticeptives, central nervous system depressants or stimulants. 6. Subjects who have clinically significant kidney ot liver ot thyroid disease. 7. Subjects who have diabetes mellitus history. 8. Subjects who have cardiovascular disease(myocardial infarction, angina pectoris, heart failure, valvular disease, etc.) history or have clinically significant ventricular tachycardia, atrial fibrillation, atrial flutter on electrocardiogram or other significant arrhythmia judged by the examiner. 9. Subjects who have cerebrovascular disease(cerebaral infarction, hemmorrhage) history. 10 Subjects with consumptive disease(tuberculosis, malignant tumors) or autoimmune disease(systemic lupus erythematosus, rheumatoid arthritis, dermatomyositis, systemic sclerosis, or thyroiditis). 11. Subjects who have chronic inflammatory conditions that need to take systemic steroid therapy or immune depressants. 12. Subjects who have a history of drug or alcohol abuse or suspected. 13. Subjects who have had hypersensivity reactions following acupuncture. 14. Subjects with hemorrhagic diseases or taking anticoagulation medications(excluding aspirin) 15. Pregnant or breast-feeding women or women who have plan to be pregnant. 16 Subjects who are participating in other clinical trials. 17. Subjects who are inmates at group facilities, such as social welfare institutions. 18. Subjects who do not provide informed consent. 19. Subjects who used traditional Korean medicinal treatment within past 1 week. 20. Others whose clinical trials conductors are considered inappropriate for participating in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| change in mean SBP and DBP levels | — |
Secondary
| Measure | Time frame |
|---|---|
| Lipid profile and hs-CRP ;BMI(Body mass index) ;PWV(pulse wave veolocity), ABI(ankle brachial index);Health Status Questionnaire(EQ-5D) ;Questinnaire of pattern indentificatiion ;Safety assessment | — |
Countries
Korea, Republic of
Contacts
Public ContactYoung-Eun Kim
Korea Institute of Oriental Medicine
Outcome results
None listed