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

Primary Purpose

Primary Ovarian Insufficiency

Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Chinese medicine granules (HuYang Yang Kun Formula)
dehydroepiandrosterone
Sponsored by
Guangzhou University of Traditional Chinese Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Ovarian Insufficiency focused on measuring primary ovarian insufficiency, TCM intervention

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept 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.

Sites / Locations

  • Guangzhou University of Traditional Chinese Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Chinese Medicine intervention

Western intervention

Arm 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

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
March 19, 2016
Last Updated
April 9, 2018
Sponsor
Guangzhou University of Traditional Chinese Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT02794948
Brief Title
Chinese Medicine(Hu Yang Yang Kun Formula) for Primary Ovarian Insufficiency
Official Title
Chinese Medicine(Hu Yang Yang Kun Formula) for Primary Ovarian Insufficiency:Randomized, Double-blind, DHEA-controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
April 2016 (undefined)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Guangzhou University of Traditional Chinese Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Ovarian Insufficiency
Keywords
primary ovarian insufficiency, TCM intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Chinese Medicine intervention
Arm Type
Experimental
Arm 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
Arm Title
Western intervention
Arm Type
Active Comparator
Arm 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.
Intervention Type
Other
Intervention Name(s)
Chinese medicine granules (HuYang Yang Kun Formula)
Intervention Description
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
Dietary Supplement
Intervention Name(s)
dehydroepiandrosterone
Intervention Description
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 Measure Information:
Title
Anti-Mullerian hormone
Description
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.
Time Frame
1year
Secondary Outcome Measure Information:
Title
Follicle stimulating hormone
Description
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.
Time Frame
1year
Title
Estrogen
Description
Estrogen is the primary female sex hormone as well as a medication.
Time Frame
1year
Title
Menopause rating scale
Description
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
Time Frame
1year
Title
Menstrual Cycle
Description
The menstrual cycle is the regular natural change that occurs in the female reproductive system (specifically the uterus and ovaries) that makes pregnancy possible.
Time Frame
1year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hongyan Yang, professor
Organizational Affiliation
Guangzhou University of Traditional Chinese Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
Guangzhou University of Traditional Chinese Medicine
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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