Chinese Medicine(Hu Yang Yang Kun Formula) for Primary Ovarian Insufficiency
NCT ID: NCT02794948
Last Updated: 2018-04-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
48 participants
INTERVENTIONAL
2016-04-30
2017-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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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
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
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.
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.
Interventions
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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
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.
Eligibility Criteria
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Inclusion Criteria
2. Menstrual cycle change more than 7 days at least 2 times,amenorrhea less than 6 months.
3. Sex hormone:bFSH\>10u/L;or E2\>80pg/ml.
4. AMH\<1ng/ml.
5. Informed consent and truthfully answer the question.
2. Genital tract malformation,congenital germinal aplasia, uterine amenorrhea and so on organic disease.
3. Endocrine diseases such Polycystic ovary syndrome、hyperprolactinemia 、dysfunctional uterine bleeding、low gonadotropin menstrual disorders and hyperthyreosis
4. Autoimmune disease patients:Hashimoto's thyroiditis,SLE,Primary chronic adrenal cortical insufficiency,Asthenic bulbar paralysis,Arthritis deformans,Idiopathic thrombocytopenic purpura, type I diabetes and so on.
5. Someone who have the following gynecological operation history: oophorocystectomy,ovarian drilling,wedgeshaped oophorectomy,adnexectomy,tubal resection,ligation of oviduct,pelvic abscess surgery,uterine arterial embolization.
6. Someone who have used reproductive toxicity drugs: tripterygium wilfordii,tripterygium hypoglaucum hutch,chemotherapeutics and so on.
7. A family history of ovarian failure.
8. Have receive hormone therapy in recent 3 months.
9. Pregnant or lactating women.
10. with serious heart,liver and kidney disease
11. With severe psychiatric disorders .
12. Have participated in other clinical trials in 3 months.
18 Years
40 Years
FEMALE
No
Sponsors
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Guangzhou University of Traditional Chinese Medicine
OTHER
Responsible Party
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Principal Investigators
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Hongyan Yang, professor
Role: STUDY_CHAIR
Guangzhou University of Traditional Chinese Medicine
Locations
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Guangzhou University of Traditional Chinese Medicine
Guangzhou, Guangdong, China
Countries
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Other Identifiers
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YN2014TS06
Identifier Type: -
Identifier Source: org_study_id
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