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NCT Number: NCT02794948

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

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

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Key information

Conditions

Primary Ovarian Insufficiency Adnexal Diseases Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Ovarian Diseases Urogenital Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Guangzhou University of Traditional Chinese Medicine

Guangzhou, Guangdong, 510000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged 18-40
  • Menstrual cycle change more than 7 days at least 2 times,amenorrhea less than 6 months.
  • Sex hormone:bFSH>10u/L;or E2>80pg/ml.
  • AMH<1ng/ml.
  • Informed consent and truthfully answer the question.

Exclusion criteria

  • Dose not meet the inclusion criteria.
  • Genital tract malformation,congenital germinal aplasia, uterine amenorrhea and so on organic disease.
  • Endocrine diseases such Polycystic ovary syndrome、hyperprolactinemia 、dysfunctional uterine bleeding、low gonadotropin menstrual disorders and hyperthyreosis
  • 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.
  • 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.
  • Someone who have used reproductive toxicity drugs: tripterygium wilfordii,tripterygium hypoglaucum hutch,chemotherapeutics and so on.
  • A family history of ovarian failure.
  • Have receive hormone therapy in recent 3 months.
  • Pregnant or lactating women.
  • with serious heart,liver and kidney disease
  • With severe psychiatric disorders .
  • Have participated in other clinical trials in 3 months.

Treatment and study plan

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

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.

Primary outcomes

  1. Anti-Mullerian hormone

    Time frame: 1year

    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.

Secondary outcomes

  1. Follicle stimulating hormone

    Time frame: 1year

    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.

  2. Estrogen

    Time frame: 1year

    Estrogen is the primary female sex hormone as well as a medication.

  3. Menopause rating scale

    Time frame: 1year

    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

  4. Menstrual Cycle

    Time frame: 1year

    The menstrual cycle is the regular natural change that occurs in the female reproductive system (specifically the uterus and ovaries) that makes pregnancy possible.

Sponsors and collaborators

Lead sponsor

Guangzhou University of Traditional Chinese Medicine

Other

Registry information

Official study title

Chinese Medicine(Hu Yang Yang Kun Formula) for Primary Ovarian Insufficiency:Randomized, Double-blind, DHEA-controlled Trial

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jun 9, 2016
Registry last updated
Apr 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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