Aricular acupuncture for pre & stage 1 hypertension patients: clinical trial

Auricular acupuncture for pre & stage 1 hypertension: a pilot multi-centre randomized controlled trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CRIS

Registry ID

KCT0000169

Enrollment

Registered

2011-08-23

Start date

2011-08-05

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device : Auricular acupuncture, which is available to be attached on the skin, will be used for this trial. Haeng Rim T-needles (Haeng Rim Seo Won Medical Co.) will be adopted for intervention

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Prehypertension or stage 1 hypertension patients (systolic blood pressure: 120 to 159 or diastolic blood pressure: 80 to 99)according to JNC 7 criteria 2. Participants who give written, informed consent

Exclusion criteria

Exclusion criteria: 1. Patients who take prescription or OTC medication or herb/supplement for controlling blood pressure 2. Secondary blood pressure patients 3. Cerebrovascular or cardiovascular disease history 4. Malignant cancer history 5. Diabetes patients who currently need insulin injection or diabetic medications 6. Several disease history: renal diseases, hepatic diseases, thyroid diseases, active Tbc and other infectious diseases 7. Hemorrhagic diseases or patients who take anti-coagulants (except aspirin) 8. Patients who have T-needle allergy 9. Local infection at ear 10. Participants who have systemic steroid therapy or immune depressants 12. Participants who take medications which may affect blood pressure such as oral anticeptives, central nervous system depressants or stimulants 13. Pregnant or breast-feeding women or women who have plan to be pregnant 14. Participants who used traditional Korean medicinal treatment during last 1 months 15. Participants who are unappropriate to this trial due to other reasons, decided by researchers

Design outcomes

Primary

Measure	Time frame
24-hour average systolic and diastolic blood pressure	—

Secondary

Measure	Time frame
Average systolic and diastolic blood pressure during awake and asleep;Circadian rhythm of blood pressure;Mean arterial pressure;Body mass index;lipid profile and hs CRP;Herat rate variability;The change of blood pressure before and after ear-acupuncture treatments in intervention group;Safety assessment	—

Countries

Korea, Republic of

Contacts

Public ContactTae-Hun Kim

Korea Institute of Oriental Medicine

Outcome results