Clinical trial NCT02794948: Chinese Medicine(Hu Yang Yang Kun Formula) for Primary Ovarian Insufficiency
Official title: Chinese Medicine(Hu Yang Yang Kun Formula) for Primary Ovarian Insufficiency:Randomized, Double-blind, DHEA-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Primary Ovarian Insufficiency
Keywords: primary ovarian insufficiency
TCM intervention
Lead sponsor: Guangzhou University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2016-06-09
Enrollment: 48
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this research is providing valuable traditional chinese medicine theory and formula in treating Primary Ovarian insufficiency.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Aged 18-40
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.

Exclusion Criteria:

1. Dose not meet the inclusion criteria.
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.

Primary outcomes:
measure: Anti-Mullerian hormone
timeFrame: 1year
Secondary outcomes:
measure: Follicle stimulating hormone
timeFrame: 1year
measure: Estrogen
timeFrame: 1year
measure: Menopause rating scale
timeFrame: 1year
measure: Menstrual Cycle
timeFrame: 1year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangzhou University of Traditional Chinese Medicine
state: Guangdong
Study officials:
affiliation: Guangzhou University of Traditional Chinese Medicine
name: Hongyan Yang, professor
role: STUDY_CHAIR
References: