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Trial record 61 of 235 for:    PRASTERONE

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

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ClinicalTrials.gov Identifier: NCT02794948
Recruitment Status : Completed
First Posted : June 9, 2016
Last Update Posted : April 10, 2018
Sponsor:
Information provided by (Responsible Party):
Guangzhou University of Traditional Chinese Medicine

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

Condition or disease Intervention/treatment Phase
Primary Ovarian Insufficiency Other: Chinese medicine granules (HuYang Yang Kun Formula) Dietary Supplement: dehydroepiandrosterone Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Chinese Medicine(Hu Yang Yang Kun Formula) for Primary Ovarian Insufficiency:Randomized, Double-blind, DHEA-controlled Trial
Study Start Date : April 2016
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2017


Arm Intervention/treatment
Experimental: 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
Other: 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

Active Comparator: 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.
Dietary Supplement: 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.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02794948


Locations
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China, Guangdong
Guangzhou University of Traditional Chinese Medicine
Guangzhou, Guangdong, China, 510000
Sponsors and Collaborators
Guangzhou University of Traditional Chinese Medicine
Investigators
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Study Chair: Hongyan Yang, professor Guangzhou University of Traditional Chinese Medicine

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Responsible Party: Guangzhou University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT02794948     History of Changes
Other Study ID Numbers: YN2014TS06
First Posted: June 9, 2016    Key Record Dates
Last Update Posted: April 10, 2018
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Guangzhou University of Traditional Chinese Medicine:
primary ovarian insufficiency
TCM intervention
Additional relevant MeSH terms:
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Dehydroepiandrosterone
Primary Ovarian Insufficiency
Menopause, Premature
Gonadal Dysgenesis
Turner Syndrome
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Disorders of Sex Development
Urogenital Abnormalities
Congenital Abnormalities
Sex Chromosome Disorders of Sex Development
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Sex Chromosome Disorders
Chromosome Disorders
Genetic Diseases, Inborn
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs