Study Summary
This clinical trial aims to evaluate the efficacy and safety of the traditional Chinese herbal formula Huanjingjian decoction in women with premature ovarian insufficiency (POI). The study is designed to address the following key questions:
1. Does Huanjingjian decoction improve clinical symptoms in patients with POI? 2. What adverse medical events, if any, occur during the treatment with Huanjingjian decoction? To answer these questions, researchers will compare Huanjingjian decoction plus hormone replacement therapy (HRT) with placebo plus HRT, in order to determine whether Huanjingjian decoction provides additional therapeutic benefits in the management of POI.
Participants will:
Receiving either Huanjingjian decoction plus HRT, or placebo plus HRT. Attending monthly clinic visits over a 6-month period for clinical assessments and laboratory testing.
Keeping a detailed diary to record symptoms, treatment adherence, and menstrual flow, as measured by the number of sanitary pads used.
Age between 18 and 39 years
Meet the diagnostic criteria for Premature Ovarian Insufficiency (POI) according to the 2024 ESHRE Guideline on Premature Ovarian Insufficiency
Menstrual disorders attributable to congenital gonadal dysgenesis or acquired structural pathologies;
Menstrual irregularities secondary to endocrine disorders, including polycystic ovary syndrome (PCOS), hyperprolactinemia, dysfunctional uterine bleeding (DUB), gonadal hormone deficiency, hyperthyroidism, and other related endocrine conditions;
Oligomenorrhea or amenorrhea induced by surgical or medical interventions, such as chemotherapy, pelvic radiotherapy, ovarian cystectomy, ovarian drilling, ovarian wedge resection, salpingectomy, tubal ligation, pelvic abscess surgery, or uterine artery embolization;
History of abnormal vaginal bleeding accompanied by clinically significant findings on endometrial biopsy, or unexplained irregular vaginal bleeding within the preceding 12 months;
Parallel
Huanjingjian decoction
DrugParticipants will receive the traditional Chinese herbal formulation Huanjingjian decoction, administered at a dose of one vial (10 ml) twice daily, taken 30 minutes after breakfast and dinner. The intervention will commence immediately following the cessation of menstruation and will continue until the onset of the subsequent menstrual period. Upon the completion of each menstrual cycle, the treatment will be resumed. Each treatment course spans 28 days, with a total of three consecutive cycles administered.
Hormone replacement therapy
DrugParticipants will begin oral administration of Utrogestan (estradiol valerate) on the 5th day of menstruation at a dose of 1 mg daily for 21 consecutive days. Starting from day 17 of treatment, medroxyprogesterone acetate will be added at a dose of 10 mg per day.
Placebo
DrugParticipants will take the placebo oral solution at a dose of 10 mL twice daily (30 minutes after breakfast and dinner). The placebo intervention will commence immediately after the cessation of menstruation and will continue until the onset of the subsequent menstrual period. At the completion of each menstrual cycle, the treatment will be resumed. Each treatment course will last for 28 days, with a total of three consecutive cycles administered.
Disease-Specific Quality of Life Assessment
The Chinese version of the Menopause-Specific Quality-of-Life questionnaire (CMS) will be used to assess disease-specific quality of life. This validated instrument demonstrates high reliability, validity, and sensitivity, and is widely recognized as a comprehensive tool for evaluating the physical and psychological well-being of Chinese women during menopause. The CMS is self-administered and uses a Likert-scale format. Each item evaluates the impact of menopausal symptoms experienced in the past month. The CMS includes 29 items across four domains: vasomotor (3 items), psychosocial (7 items), physical (16 items), and sexual (3 items). Respondents first indicate whether a symptom is present; if endorsed, they rate its severity from 0 (not bothersome) to 6 (extremely bothersome). Each item is scored from 1 (not present) to 8 (extremely bothersome). Assessments will be conducted at baseline, 3 months, and 6 months.
Changes in serum anti-Müllerian hormone (AMH) levels
Assessments will be conducted at baseline, 3 months, and 6 months, with measurements taken on day 3 of the menstrual cycle.
Change in follicle-stimulating hormone (FSH) levels
Assessments will be conducted at baseline, 3 months, and 6 months, with measurements taken on day 3 of the menstrual cycle.
Change in luteinizing hormone (LH) levels
Assessments will be conducted at baseline, 3 months, and 6 months, with measurements taken on day 3 of the menstrual cycle.
Change in estradiol (E2) levels
Assessments will be conducted at baseline, 3 months, and 6 months, with measurements taken on day 3 of the menstrual cycle.
Number of participants with adverse events as assessed by CTCAE v4.0 （Safety Outcome）
All adverse events occurring throughout the intervention and follow-up periods will be recorded.
Morisky Medication Adherence Scale (MMAS-8)
The Morisky Medication Adherence Scale (MMAS-8) is a widely used self-reported questionnaire designed to assess patients' medication adherence. The scale consists of 8 items, with a total score ranging from 0 to 8. Higher scores indicate better adherence. A score of 8 indicates high adherence, scores of 6-7 indicate medium adherence, and scores below 6 indicate low adherence. The assessment will be conducted at 6 months.
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Shanghai Pulmonary Hospital, Shanghai, China
Lead sponsor
Shanghai University of Traditional Chinese Medicine
Collaborator
Shanghai Geriatric Institute of Chinese Medicine
Collaborator
Shanghai Institute of Acupuncture and Anesthesia, Shanghai
Collaborator
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Collaborator
Jingan Hospital of Traditional Chinese Medicine
Collaborator
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