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

NCT ID: NCT02794948

Last Updated: 2018-04-10

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2017-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Primary Ovarian Insufficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

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

Group Type EXPERIMENTAL

Chinese medicine granules (HuYang Yang Kun Formula)

Intervention Type 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

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.

Group Type ACTIVE_COMPARATOR

dehydroepiandrosterone

Intervention Type 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.

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

Intervention Type OTHER

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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Guangzhou University of Traditional Chinese Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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China

Other Identifiers

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YN2014TS06

Identifier Type: -

Identifier Source: org_study_id

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