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IRCT20110809007265N13 IRCT 2022-08-27 Mashhad University of Medical Sciences Evaluation of ear acupuncture on reduction of blood pressure The effect of Auricular acupuncture on reduction of blood pressure in patients with chronic essential hypertension: A randomized sham-controled clinical trial 2022-08-21 anticipated 60 Complete https://irct.ir/trial/64908 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: This is simple randomization .Each patient takes an concealed envelope containing letter A or B for true or sham group.These envelopes were provided by statistic analyzer of the study. The main researcher pastes either true needle tag or sham needle-free tag to the patients based on letter A or B.These tags are apparently identical, Blinding description: The patients,health personnel who check BP and outcomes,research analyzer and data gathering person are blinded but the main researcher who inserts adhesive tapes is not blinded. 3 Essential hypertension. Intervention 1: After randomization,standard SF-36questionarie filled out by patients and blood pressure measured by digital arm sphygmomannometer.4 adhesive tape containg1mm needle in its center are pasted to specific ear points(shenmen,superior triangular fossa,Chinese liver and heart )on right ear.7 days later patients will come back and tapes removed and blood pressure be measured and new tapes pasted on the points on left ear.4 times (4weeks) will be dine again with tapes 2weeks on right and 2weeks on left ear.at end of last session SF-36questionarie will be filled by patients.after one month patients will come back for follow up and blood pressure will be measured and the questionnaire will be filled. Intervention 2: After randomization,standard SF-36 questionarie filled out by patients and blood pressure measured by digital arm sphygmomannometer.4 adhesive tape free of needle are pasted to specific ear points(shenmen,superior triangular fossa,Chinese liver and heart ) on right ear. Seven days later patients will come back and tapes removed and blood pressure be measured and new tapes pasted on the points on left ear.Four times (4 weeks) will be done again with tapes 2 weeks on right and 2 weeks on left ear.at end of last session SF-36 questionarie will be filled by patients. After one month patients will come back for follow up and blood pressure will be measured and the questionnaire will be filled. No - There is not a plan to make this available Justification or reason for not sharing IPD is It depends on the written permission of patients who participate in this study
public Rahim Firoyzi bostanabad
No.7, Baharan Building, Azadi Street
Tabriz Iran (Islamic Republic of) 5163951468 +98 41 3335 9748 rahim4040@yahoo.com Mashhad University of Medical Sciences scientific Hoda azizi
Pardis campus, Azadi squre
Mashhad Iran (Islamic Republic of) 9177899191 +98 51 3884 8931 azizih@muma.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Age equal or more than 18 Essential hypertension (not secondary) blood pressure less than 180/120 mmHg in preceding month 18 years no limit Both Organ disease such as heart, lung ,renal disease … cardiovascular complications taking drug for cancer .seizure participation in other trials taking acupuncture pregnant or breast-feeding I10 Essential (primary) hypertension Treatment - Other Treatment - Other After randomization,standard SF-36questionarie filled out by patients and blood pressure measured by digital arm sphygmomannometer.4 adhesive tape containg1mm needle in its center are pasted to specific ear points(shenmen,superior triangular fossa,Chinese liver and heart )on right ear.7 days later patients will come back and tapes removed and blood pressure be measured and new tapes pasted on the points on left ear.4 times (4weeks) will be dine again with tapes 2weeks on right and 2weeks on left ear.at end of last session SF-36questionarie will be filled by patients.after one month patients will come back for follow up and blood pressure will be measured and the questionnaire will be filled. After randomization,standard SF-36 questionarie filled out by patients and blood pressure measured by digital arm sphygmomannometer.4 adhesive tape free of needle are pasted to specific ear points(shenmen,superior triangular fossa,Chinese liver and heart ) on right ear. Seven days later patients will come back and tapes removed and blood pressure be measured and new tapes pasted on the points on left ear.Four times (4 weeks) will be done again with tapes 2 weeks on right and 2 weeks on left ear.at end of last session SF-36 questionarie will be filled by patients. After one month patients will come back for follow up and blood pressure will be measured and the questionnaire will be filled. Systolic blood pressure,Diastolic blood pressure,mean blood pressure. Timepoint: Before and after intervention,at the end of 1 month followup. Method of measurement: Digital arm sphygmomanometer. Quality of life. Timepoint: Before and after the intervention, at the end of 1 month follow up. Method of measurement: Questionary. Change in medication dose. Timepoint: Before and after the intervention, at the end of 1 months follow up. Method of measurement: study checklist. Mashhad University of Medical Sciences Approved 2022-07-19 Ethics committee of Mashhad University of Medical Sciences Qorashi building, Daneshgah Street Mashhad Razavi Khorasan Iran (Islamic Republic of)