Efficacy and Safety of Huanjingjian Decoction in Women With Premature Ovarian Insufficiency

Not Applicable

Not yet recruiting

• Conditions: Premature Ovarian Insufficiency
• Interventions: Drug: Huanjingjian decoction; Drug: Hormone replacement therapy; Drug: Placebo

• Registration Number: NCT07020429
• Lead Sponsor: Shanghai Pulmonary Hospital, Shanghai, China

Brief Summary

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.

Detailed Description

This study is a prospective, randomized, controlled clinical trial designed to evaluate the efficacy of the traditional Chinese herbal formula Huanjingjian decoction in combination with hormone replacement therapy for the treatment of premature ovarian insufficiency. The primary objective is to determine whether the addition of Huanjingjian decoction to hormone replacement therapy provides greater improvement in clinical symptoms compared with placebo combined with hormone replacement therapy. It is hypothesized that, at 12 weeks, treatment with Huanjingjian decoction in combination with hormone replacement therapy will result in superior clinical outcomes relative to placebo combined with hormone replacement therapy.

Study Timeline

• Study First Submitted: 2025-05-16
• Study First Submitted QC: 2025-06-05
• Study First Posted: 2025-06-13
• Status Verified: 2025-09
• Study Start: 2025-09-01
• Last Update Submitted: 2025-09-01
• Last Update Posted: 2025-09-08
• Primary Completion: 2030-07-30
• Study Completion: 2030-07-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 276

Inclusion Criteria

• 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

Exclusion Criteria

• 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;
• Suspected cervical malignancy or precancerous cervical lesions, suspected malignant breast tumors, or a known or suspected history of hormone-dependent tumors or malignancies;
• Previous or current history of deep vein thrombosis (DVT), pulmonary embolism, thrombotic disorders, or cerebrovascular events (stroke);
• Presence of uncontrolled and/or undiagnosed systemic diseases that could confound study results or compromise patient safety, including severe hepatic, renal, cardiac, or neurological disorders;
• Known hypersensitivity or allergy to any study-related medications;
• Pregnancy or lactation;
• Participation in other clinical trials within the last 3 months;
• Failure or refusal to provide written informed consent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Huanjingjian decoction + Hormone replacement therapy	Huanjingjian decoction	Participants in this group will receive treatment with Huanjingjian decoction in combination with hormone replacement therapy (HRT).
Huanjingjian decoction + Hormone replacement therapy	Hormone replacement therapy	Participants in this group will receive treatment with Huanjingjian decoction in combination with hormone replacement therapy (HRT).
Placebo + Hormone replacement therapy	Hormone replacement therapy	Participants in this group will receive treatment with hormone replacement therapy (HRT) in combination with placebo.
Placebo + Hormone replacement therapy	Placebo	Participants in this group will receive treatment with hormone replacement therapy (HRT) in combination with placebo.

Primary Outcome Measures

Name	Time	Method
Disease-Specific Quality of Life Assessment	From the time of enrollment through the 6-month follow-up period	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.

Secondary Outcome Measures

Name	Time	Method
Changes in serum anti-Müllerian hormone (AMH) levels	From the time of enrollment through the 6-month follow-up period	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	From the time of enrollment through the 6-month follow-up period	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	From the time of enrollment through the 6-month follow-up period	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	From the time of enrollment through the 6-month follow-up period	Assessments will be conducted at baseline, 3 months, and 6 months, with measurements taken on day 3 of the menstrual cycle.
Menstrual recovery rate	From the time of enrollment through the 6-month follow-up period	The menstrual recovery rate (%) will be calculated as follows: Menstrual Recovery Rate (%) = (Number of participants with menstrual recovery ÷ Total number of participants) × 100%. Assessment of this outcome will be conducted at 6 months.
Antral follicle count	From the time of enrollment through the 6-month follow-up period	Antral follicle count (AFC) will be assessed by transvaginal ultrasound between days 2 and 5 of the menstrual cycle at baseline, 3 months, and 6 months. Menstruation may be spontaneous or induced with progestin; in cases of persistent amenorrhea, ovarian function assessment will be performed irrespective of the menstrual cycle.
Ovarian volume evaluation	From the time of enrollment through the 6-month follow-up period	Ovarian volume evaluation will be assessed by transvaginal ultrasound between days 2 and 5 of the menstrual cycle at baseline, 3 months, and 6 months. Menstruation may be spontaneous or induced with progestin; in cases of persistent amenorrhea, ovarian function assessment will be performed irrespective of the menstrual cycle.
Generic quality of life	From the time of enrollment through the 6-month follow-up period	Generic quality of life will be assessed using the Short Form-36 Health Survey (SF-36) at baseline, 3 months, and 6 months to evaluate the overall impact of the intervention on health-related quality of life. The SF-36 is a validated and widely used instrument comprising eight domains: physical functioning, role limitations due to physical or emotional problems, bodily pain, general health, vitality, social functioning, and mental health. Scores range from 0 to 100, with higher scores indicating better perceived health status.

Trial Locations

Locations (1)

Jingan hospital of Traditional Chinese Medicine; 🇨🇳 Shanghai, China