Acupuncture for Relieving Perimenopausal Symptoms
|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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01933204
|Contact: Erqi Qin, Masteremail@example.com|
|Chengdu University of Traditional Chinese Medicine||Not yet recruiting|
|Chengdu, Sichuan, China, 610075|
|Contact: Erqi Qin, Master 028-66875871 firstname.lastname@example.org|
|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 email@example.com|
|Principal Investigator:||Ying Li, MD, PhD||Chengdu University of Traditional Chinese Medicine|