Premature Ovarian Insufficiency (POI)
Conditions
Interventions
Treatment group A:Femoston
Treatment group B:Bushen Ningxin Decoction
Treatment group C:Bushen Ningxin Decoction combined with Femoston
Sponsors
Affiliated Hospital of Nanjing University of Traditional Chinese Medicine, Jiangsu Provincial Hospital of Traditional Chinese Medicine
Eligibility
Sex/Gender
Female
Age
20 Years to 40 Years
Inclusion criteria
Inclusion criteria: 1. Chinese women aged 20-40 years; 2. Meet the diagnostic criteria of Western medicine (POI); 3. Comply with the diagnosis standard of TCM syndrome differentiation (heart and kidney do not submit syndrome); 4. Meet the diagnostic criteria for circadian rhythm disorder sleep-wake disorder in the third edition of the National Classification of Sleep Disorders (ICSD-3); 5. No history of hormone drugs and drugs affecting glucose metabolism in the first 3 months of treatment; 6. Volunteer participation and informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with POI caused by bilateral ovarian resection, primary amenorrhea in puberty, combined with uterine or ovarian organic lesions, reproductive system or breast cancer; 2. Oligomenorrhea or amenorrhea caused by endocrine diseases such as polycystic ovary syndrome, adrenal hyperplasia, hyperprolactinemia, Sheehan syndrome; 3. POI manifested as premenstrual; 4. Congenital abnormal development of reproductive organs; 5. Patients with serious primary diseases such as liver and kidney system, cardiovascular or hematopoietic system; 6. Patients with mental illness; 7. Those with contraindications or allergies to hormone drugs; 8. Combined with other medical, neurological and mental diseases: abnormal thyroid function, dementia, Parkinson's syndrome, schizophrenia and other sleep disorders.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| serum follicle-stimulating hormone level;ovulation rate;insomnia severity index;Pittsburgh Sleep Quality Index;total clinical response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| serum sex hormone level;inducible nitric oxide synthase;endothelin-1;serum inflammatory markers;ovarian arterial blood flow index;TCM symptom score;fatigue scale score;Hamilton Depression Scale Score; | — |
Countries
China
Contacts
Public ContactMa Weirong
Affiliated Hospital of Nanjing University of Traditional Chinese Medicine, Jiangsu Provincial Hospital of Traditional Chinese Medicine
Outcome results
None listed