Effects of Acupuncture at ST36 and PC6 on Blood Pressure and Endothelial Dysfunction in Hypertensive Patients
The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by Kyunghee University Medical Center.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Kyunghee University Medical Center
Information provided by:
Kyunghee University Medical Center
ClinicalTrials.gov Identifier:
NCT01002846
First received: October 26, 2009
Last updated: NA
Last verified: October 2009
History: No changes posted
| Tracking Information | |||||||||
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| First Received Date ICMJE | October 26, 2009 | ||||||||
| Last Updated Date | October 26, 2009 | ||||||||
| Start Date ICMJE | September 2009 | ||||||||
| Estimated Primary Completion Date | June 2010 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
To assess effects of acupuncture on endothelial function with FMD variation after 8 weeks treatments. [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures ICMJE |
To examine the effects of acupuncture on blood pressure, lipid , hsCRP level variation with ABPM after 8 weeks treatments. [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Effects of Acupuncture at ST36 and PC6 on Blood Pressure and Endothelial Dysfunction in Hypertensive Patients | ||||||||
| Official Title ICMJE | Effects of Acupuncture at ST36 and PC6 on Blood Pressure and Endothelial | ||||||||
| Brief Summary | This is randomised, controlled study about effects of acupuncture on blood pressure and endothelial dysfunction in stage I hypertension patient without medication. Subject will receive 8 weeks of either acupuncture or sham acupuncture, measuring FMD and blood test before and after treatment. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 3 | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
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| Condition ICMJE | Hypertension | ||||||||
| Intervention ICMJE | Procedure: acupuncture
acupuncture group : subject will undergo 20minute sessions twice a week for 8weeks. Disposable acupuncture needle(4cm sterilized stainless steel) will be inserted up to 1 cm depth sham acupuncture group : subject will undergo 20 minute. Disposable acupuncture needle(4cm sterilized stainless steel) will be inserted under 1 cm slightly. |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 32 | ||||||||
| Estimated Completion Date | June 2010 | ||||||||
| Estimated Primary Completion Date | June 2010 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 70 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Korea, Republic of | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01002846 | ||||||||
| Other Study ID Numbers ICMJE | KHNMC/5H/IRB/2009/007 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Oriental Medicine of Stroke & Neurological Disorders Center | ||||||||
| Study Sponsor ICMJE | Kyunghee University Medical Center | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Kyunghee University Medical Center | ||||||||
| Verification Date | October 2009 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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