Efficacy of Bushen Ningxin Decoction combined with Femoston in the treatment of heart-kidney imbalanced Premature Ovarian Insufficiency with Circadian rhythm disorder: protocol for a randomized controlled pilot trial

Phase 4

Recruiting

Conditions: Premature Ovarian Insufficiency

Registration Number: ITMCTR2100005476

Lead Sponsor: Jiangsu Province Hospital of Chinese Medicine, Affiliated Hospital of Nanjing University of Chinese Medicine

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Female

Target Recruitment: Not specified

Inclusion Criteria

(1) Chinese women aged from 20 to 40 years old.
(2) Confirmed diagnosis of POI according to the 2017 Chinese expert consensus on POI diagnosis and treatment:
(a) women under 40 years of age;
(b) irregular menstruation cycles (sporadic menstruation or menopause for at least 4 months);
(c) serum basal FSH level of 25 to 40 IU/L at least twice (4 weeks interval);
(d) karyotype normal: 46, XX.
(3) In line with the diagnosis criteria of TCM syndrome differentiation: heart-kidney imbalance.
(4) It meets the diagnostic criteria of ICSD-3 for circadian dysrhythmia sleep and wake disorder: Chronic recurrent sleep and wake disorders are mainly caused by changes in endogenous circadian timing system, or the disharmony between endogenous circadian rhythm and expected sleep and wake time, or with individual environment, society, and working time.
(5) No history of using hormone drugs or drugs that affect glucose metabolism within the 3 months prior to treatment.
(6) Volunteer to participate in this trial and give informed consent.

Exclusion Criteria

(1) POI caused by bilateral ovariectomy, primary amenorrhea in puberty, combined with organic disease of uterus or ovary, reproductive system or breast malignant tumor;
(2) Sparse menstruation or amenorrhea is caused by endocrine diseases such as polycystic ovary syndrome, adrenal cortical hyperplasia, hyperprolactinemia and Sheehan syndrome;
(3) Patients with premenstrual POI;
(4) Congenital abnormal development of reproductive organs;
(5) Patients with serious primary diseases such as liver and kidney system, cardiovascular system or hematopoietic system;
(6) People with mental diseases;
(7) Contraindications or allergies of hormone drugs;
(8) Patients with other medical, neurological or mental diseases: thyroid dysfunction, dementia, Parkinson's syndrome, schizophrenia and other sleep disorders.

Study & Design

Study Type: Interventional study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
total clinical response rate;Pittsburgh Sleep Quality Index;Insomnia severity index;serum FSH level;ovulation rate;

Secondary Outcome Measures

Name	Time	Method
TCM symptom score;ovarian arterial blood flow index;serum sex hormone level;iNOS;ET-1;fatigue scale score;serum inflammatory markers;Hamilton Depression Scale score;