Chinese Medicine(Hu Yang Yang Kun Formula) for Primary Ovarian Insufficiency

Guangzhou University of Traditional Chinese Medicine

Status and phase: Completed; Phase 2; Phase 1

Conditions: Primary Ovarian Insufficiency

Treatments: Other: Chinese medicine granules (HuYang Yang Kun Formula); Dietary Supplement: dehydroepiandrosterone

Study type: Interventional

Funder types: Other

Identifiers

NCT02794948

YN2014TS06

Details and patient eligibility

About

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

Full 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.

Enrollment: 48 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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48 participants in 2 patient groups

Chinese Medicine intervention

Experimental group

Description:

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

Treatment:

Other: Chinese medicine granules (HuYang Yang Kun Formula)

Western intervention

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: dehydroepiandrosterone