Acupuncture for Relieving Perimenopausal Symptoms
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|ClinicalTrials.gov Identifier: NCT01933204|
Recruitment Status : Unknown
Verified August 2013 by Chengdu University of Traditional Chinese Medicine.
Recruitment status was: Recruiting
First Posted : September 2, 2013
Last Update Posted : September 4, 2013
|Condition or disease||Intervention/treatment||Phase|
|Perimenopause||Other: Acupuncture Drug: Climen 21 Tablets||Phase 2 Phase 3|
- A randomised controlled trial with superiority design
- A total of 220 participants will be included in 3 centers
- 2 arms: acupuncture group and Climen® group
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||220 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Acupuncture for Relieving Perimenopausal Symptoms: a Randomised Controlled Trial|
|Study Start Date :||September 2013|
|Estimated Primary Completion Date :||August 2015|
|Estimated Study Completion Date :||August 2015|
Using basic points combined with additional points. Basic points are fixed, while additional points will be selected from a list of points categorized by syndrome differentiation.
Acupuncture is a collection of procedures involving penetration of the skin with needles to stimulate certain points on the body. In its classical form it is a characteristic component of traditional Chinese medicine (TCM), a form of alternative medicine, and one of the oldest healing practices in the world.
Active Comparator: Climen 21 Tablets
COMPOSITION 11 white tablets each containing estradiol-17-valerate 2 mg, plus 10 pink tablets each containing estradiol-17-valerate 2 mg and cyproterone acetate 1 mg.
Drug: Climen 21 Tablets
Climen Tablets are commonly used for menopausal symptoms
Other Name: Climen Tablets
- Menopause Rating Scale [ Time Frame: 12 weeks after randomization ]The scale was developed and validated over the years from a research network of many institutions such as Organon Germany, Infratest Munich, Universities of Muenster and Berlin,the Berlin Center for Epidemiology and Health Research, etc. It is a scale consisted of 11 items, ranging from no symptoms to very severe symptoms.
- Menopausal Specific Quality of Life Questionnaire [ Time Frame: asessed 0, 6, 12, 24, 36 weeks after randomization ]The Menopausal Specific Quality of Life Questionnaire (MENQOL) is self-administered and consists of a total of 29 items in a Likert-scale format. Each item assesses the impact of one of four domains of menopausal symptoms, as experienced over the last month: vasomotor (items 1-3), psychosocial (items 4-10), physical (items 11-26), and sexual (items 27-29).
- Average hot flash score during 24 hours [ Time Frame: 0, 12, 24, 36 weeks after randomization ]
- Level of Estradiol in serum [ Time Frame: 0, 12, 24 weeks after randomization ]
- Level of follicle stimulating hormone in serum [ Time Frame: 0, 12, 24 weeks after randomization ]
- Level of luteinizing hormone in serum [ Time Frame: 0, 12, 24 weeks after randomization ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01933204
|Contact: Erqi Qin, Masterfirstname.lastname@example.org|
|Chengdu University of Traditional Chinese Medicine||Not yet recruiting|
|Chengdu, Sichuan, China, 610075|
|Contact: Erqi Qin, Master 028-66875871 email@example.com|
|Sub-Investigator: Hui Zheng, MD, PhD|
|First affiliated hospital of Chengdu University of TCM||Recruiting|
|Chengdu, Sichuan, China, 610075|
|Contact: Er-qi Qin, MD 028-66875871 firstname.lastname@example.org|
|Principal Investigator:||Ying Li, MD, PhD||Chengdu University of Traditional Chinese Medicine|