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

NCT02794948 | Completed Phase 1 DMC

• 1 other identifier: YN2014TS06
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Primary Ovarian Insufficiency

Keywords

primary ovarian insufficiency; TCM intervention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Follicle stimulating hormone

  1year

• Estrogen

  1year

• Menopause rating scale

  1year

• Menstrual Cycle

  1year

Study Arms (2)

Chinese Medicine intervention

EXPERIMENTAL

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)

Western intervention

ACTIVE COMPARATOR

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

Interventions

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

Chinese Medicine intervention

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.

Western intervention

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guangzhou University of Traditional Chinese Medicine: lead

Study Sites (1)

Guangzhou University of Traditional Chinese Medicine

Guangzhou, Guangdong, 510000, China

Location

MeSH Terms

Conditions

Primary Ovarian Insufficiency

Interventions

Dehydroepiandrosterone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Androstenols; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 17-Ketosteroids; Ketosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones

Study Officials

• Hongyan Yang, professor

  Guangzhou University of Traditional Chinese Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2016
• First Posted: June 9, 2016
• Study Start: April 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: April 10, 2018

Record last verified: 2016-03

Locations

CN (1)