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

Primary Ovarian Insufficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02794948
• Other study ID #: YN2014TS06
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: March 19, 2016
• Last updated: April 9, 2018
• Start date: April 2016
• Est. completion date: December 2017

Study information

• Verified date: March 2016
• Source: Guangzhou University of Traditional Chinese Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gonadal Dysgenesis
• Menopause, Premature
• Primary Ovarian Insufficiency
• Turner Syndrome

Intervention

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

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.

Locations

Country	Name	City	State
China	Guangzhou University of Traditional Chinese Medicine	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangzhou University of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anti-Mullerian hormone	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.	1year
Secondary	Follicle stimulating hormone	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.	1year
Secondary	Estrogen	Estrogen is the primary female sex hormone as well as a medication.	1year
Secondary	Menopause rating scale	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	1year
Secondary	Menstrual Cycle	The menstrual cycle is the regular natural change that occurs in the female reproductive system (specifically the uterus and ovaries) that makes pregnancy possible.	1year