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A multicenter, randomized, double-blind, placebo-controlled post marketing clinical trial to evaluate the efficacy and safety of Dong'e Ejiao in the treatment of early-onset ovarian insufficiency (blood deficiency syndrome)

A multicenter, randomized, double-blind, placebo-controlled post marketing clinical trial to evaluate the efficacy and safety of Dong'e Ejiao in the treatment of early-onset ovarian insufficiency (blood deficiency syndrome)

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2200006561
Enrollment
Unknown
Registered
2022-09-04
Start date
2022-09-01
Completion date
Unknown
Last updated
2023-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Early onset ovarian insufficiency

Interventions

control group:Dong'e Ejiao mimetic (powder): 9g / bag, 1 bag / time, 1 time / day, boiled water
experimental group:Dong'e Ejiao (powder): 9g / bag, 1 bag / time, 1 time / day, boiled water

Sponsors

Beijing Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: (1) Consistent with the diagnosis of early-onset ovarian insufficiency; (2) In accordance with the syndrome differentiation of blood deficiency; (3) At baseline, serum follicle stimulating hormone (FSH): 25-40u / L; (4) Voluntarily participate in this clinical trial, give informed consent and sign the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Age 1mg and didroxyprogesterone > 10mg); (6) Have received non hormonal drugs and non drug treatments (such as acupuncture, external application, enema, etc.) that have therapeutic effects on the disease in the past 1 month; (7) ALT or AST = 1.5 times the upper limit of normal reference value or SCR > the upper limit of normal reference value; (8) Mental retardation or psychosis or neurosis; (9) Complicated with serious primary diseases such as heart, brain, lung, liver, kidney, endocrine, nervous system and hematopoietic system; (10) Combined with BI-RADS grade > 3 and uterine leiomyoma > 3cm; (11) There are symptoms of nausea, abdominal distension, loose stools, yellow and greasy tongue coating; (12) There are contraindications to periodic treatment with fenmutone hormone, known or suspected history of breast cancer, known or suspected estrogen dependent tumor (such as endometrial cancer), unexplained genital bleeding, untreated endometrial hyperplasia, previous idiopathic or existing venous thromboembolism (deep venous embolism, pulmonary embolism), active or recent arterial thromboembolic disease (such as angina pectoris, myocardial infarction), history of meningioma Acute liver disease or history of liver disease, failure to restore normal liver function indicators, known hypersensitivity to active components of fenbutone or any excipients, porphyria; (13) Pregnant and lactating women or within half a year have family planning; (14) Suspected or actual history of alcohol and drug abuse; (15) Known or suspected history of allergy to the ingredients and excipients of the test drug; (16) Participated in other clinical trials in the past 3 months; (17) The investigator considers it inappropriate to participate in this clinical trial.

Design outcomes

Primary

MeasureTime frame
FSH;

Secondary

MeasureTime frame
AMH;Transvaginal ultrasound;Five items of sex hormone;AMH;Kupperman;AMH;

Countries

China

Contacts

Public ContactXiuxiang Teng
tengxx@126.com010-87906913

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026