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The purpose of this research is providing valuable traditional chinese medicine theory and formula in treating Primary Ovarian insufficiency.
Primary ovarian insufficiency is a problem that is to be solved urgently in the field of reproductive endocrine. According to the basic theory of traditional Chinese Medicine and clinical experience, investigators developed a Chinese medicine formula(Hu yang yang kun,Hyyk). This research is designed according to the principle of randomized double blind control and evaluated the effectiveness and safety of Hyyk, hope to provide a kind of effective medicine in treating primary ovarian insufficiency.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chinese Medicine intervention | Experimental | 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 |
|
| Western intervention | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chinese medicine granules (HuYang Yang Kun Formula) | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Anti-Mullerian hormone | 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. | 1year |
| Measure | Description | Time Frame |
|---|---|---|
| Follicle stimulating hormone | FSH is a gonadotropin, a glycoprotein polypeptide hormone. FSH is synthesized and secreted by the gonadotropic cells of the anterior pituitary gland,[1] and regulates the development, growth, pubertal maturation, and reproductive processes of the body. | 1year |
| Estrogen |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hongyan Yang, professor | Guangzhou University of Traditional Chinese Medicine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangzhou University of Traditional Chinese Medicine | Guangzhou | Guangdong | 510000 | China |
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| ID | Term |
|---|---|
| D016649 | Primary Ovarian Insufficiency |
| ID | Term |
|---|---|
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D003687 | Dehydroepiandrosterone |
| ID | Term |
|---|---|
| D000737 | Androstenols |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 |
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|
| dehydroepiandrosterone | Dietary Supplement | 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. |
|
Estrogen is the primary female sex hormone as well as a medication. |
| 1year |
| Menopause rating scale | 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 | 1year |
| Menstrual Cycle | The menstrual cycle is the regular natural change that occurs in the female reproductive system (specifically the uterus and ovaries) that makes pregnancy possible. | 1year |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D015068 | 17-Ketosteroids |
| D007664 | Ketosteroids |
| D000305 | Adrenal Cortex Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045165 | Testosterone Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |