Acupuncture in Menopause (AIM)
| Tracking Information | |||||
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| First Received Date ICMJE | January 11, 2011 | ||||
| Last Updated Date | December 21, 2012 | ||||
| Start Date ICMJE | April 2011 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
Subjective Hot Flashes [ Time Frame: Up to 14 months ] [ Designated as safety issue: No ] Hot Flashes will be monitored via daily diary. This diary will be filled out daily for the first six months (post randomization) of the study and then 1 week per month for the remaining 6 months of the study. |
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| Original Primary Outcome Measures ICMJE |
Subjective Hot Flashes [ Time Frame: Weekly ] [ Designated as safety issue: No ] Hot Flashes will be monitored via daily diary. This diary will be filled out daily for the first six months of the study and then 1 week per month for the additional 6 months of the study. Participants are followed approximately 1 year from enrollment. |
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| Change History | Complete list of historical versions of study NCT01276028 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Acupuncture in Menopause | ||||
| Official Title ICMJE | Acupuncture for Vasomotor Symptoms | ||||
| Brief Summary | The primary purpose of this study is to determine the effectiveness of acupuncture for treating vasomotor and other symptoms associated with menopause as acupuncture is generally practiced in the "real world" setting and to obtain a comprehensive assessment of use patterns and symptom relief over time. This study will allow us to determine treatment patterns recommended by practicing acupuncturists, adherence to these treatments, and the effectiveness of different treatment patterns for reducing hot flashes. Results of this study will provide meaningful information to women in terms of number and frequency of acupuncture treatments likely to be needed to reduce hot flashes. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 2 | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Vasomotor Symptoms | ||||
| Intervention ICMJE | Procedure: Acupuncture
For the Acupuncture group: Women will be eligible to receive from 1 to 20 treatments over a six month period. These women will receive an initial evaluation by a acupuncturist and will be given a Traditional Chinese Medicine (TCM) diagnosis as well as a recommended treatment schedule which they can then negotiate. Women in the waitlist group will not receive any acupuncture for 6 months. At the end of the 6 month period the participants will be allowed to begin the acupuncture treatments. |
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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 | 200 | ||||
| Completion Date | Not Provided | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 45 Years to 60 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01276028 | ||||
| Other Study ID Numbers ICMJE | IRB00014892 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Nancy Avis, PhD, Wake Forest University Health Sciences | ||||
| Study Sponsor ICMJE | Wake Forest University Baptist Medical Center | ||||
| Collaborators ICMJE | National Institutes of Health (NIH) | ||||
| Investigators ICMJE |
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| Information Provided By | Wake Forest University Baptist Medical Center | ||||
| Verification Date | December 2012 | ||||
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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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