Chinese Medicine(Hu Yang Yang Kun Formula) for Primary Ovarian Insufficiency
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|ClinicalTrials.gov Identifier: NCT02794948|
Recruitment Status : Completed
First Posted : June 9, 2016
Last Update Posted : April 10, 2018
|Condition or disease||Intervention/treatment||Phase|
|Primary Ovarian Insufficiency||Other: Chinese medicine granules (HuYang Yang Kun Formula) Dietary Supplement: dehydroepiandrosterone||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||48 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Chinese Medicine(Hu Yang Yang Kun Formula) for Primary Ovarian Insufficiency:Randomized, Double-blind, DHEA-controlled Trial|
|Study Start Date :||April 2016|
|Actual Primary Completion Date :||December 2017|
|Actual Study Completion Date :||December 2017|
Experimental: Chinese Medicine intervention
Chinese medicine HuYang Yang Kun Formula 1 capsule every time per day for 3 day per month, DHEA(dehydroepiandrosterone) placebo 1 sack every time, twice a day for three months
Other: Chinese medicine granules (HuYang Yang Kun Formula)
Take Chinese medicine granules (HuYang Yang Kun Formula), 1 sack every time,twice a day Take DHEA(dehydroepiandrosterone) placebo,1 capsule every time ,once a day. Treatment for 3 months Both Chinese Medicine formula granules and DHEA placebo were produced by Jiangyin Medical &pharmaceutical limited company in Jiangsu province
Active Comparator: Western intervention
DHEA(dehydroepiandrosterone) 1 sack every time twice a day for three months. Chinese medicine formula granules placebo 1 capsule every time per day for 3 day per month.
Dietary Supplement: dehydroepiandrosterone
The DHEA( dehydroepiandrosterone)25mg,1 capsule every time once a day. Take Chinese medicine granules placebo , 1 sack every time,twice a day Treatment is 3 months. DHEA were produced by General Nutrition Center(GNC)company in America and The placebo granules of Chinese Medicine were produced by Jiangyin Medical &pharmaceutical limited company in Jiangsu province.
- Anti-Mullerian hormone [ Time Frame: 1year ]Anti-Mullerian hormone (AMH) is a gonadal hormone synthesized by granulose cells of the ovary and Sertoli cells of the testis. Anti-Mullerian hormone is used to facilitate the evaluation of intersex disorders and as a marker in ovarian reserve assessment in the infertility cases.
- Follicle stimulating hormone [ Time Frame: 1year ]FSH is a gonadotropin, a glycoprotein polypeptide hormone. FSH is synthesized and secreted by the gonadotropic cells of the anterior pituitary gland, and regulates the development, growth, pubertal maturation, and reproductive processes of the body.
- Estrogen [ Time Frame: 1year ]Estrogen is the primary female sex hormone as well as a medication.
- Menopause rating scale [ Time Frame: 1year ]The scale was designed and standardized as a self-administered scale to assess symptoms/complaints of aging women under different conditions, to evaluate the severity of symptoms over time, and to measure changes pre- and postmenopause replacement therapy
- Menstrual Cycle [ Time Frame: 1year ]The menstrual cycle is the regular natural change that occurs in the female reproductive system (specifically the uterus and ovaries) that makes pregnancy possible.
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): NCT02794948
|Guangzhou University of Traditional Chinese Medicine|
|Guangzhou, Guangdong, China, 510000|
|Study Chair:||Hongyan Yang, professor||Guangzhou University of Traditional Chinese Medicine|