Efficacy and Safety of the Traditional Chinese Herbal Formula Huanjingjian Decoction in Women With Premature Ovarian Insufficiency: a Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 276
- 试验地点
- 1
- 主要终点
- Disease-Specific Quality of Life Assessment
研究概览
简要总结
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:
- Does Huanjingjian decoction improve clinical symptoms in patients with POI?
- 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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Participants, care providers, investigators, and outcome assessors will remain blinded to the treatment allocation throughout the trial. Randomisation codes will be generated by an independent statistician who is not involved in participant recruitment. Study medications (Huanjingjian decoction and placebo) will be manufactured and packaged to be identical in appearance, taste, and packaging. Sealed envelopes containing the randomisation codes will be kept securely by the clinical trial unit and may only be opened in case of a medical emergency or a serious adverse event requiring unblinding. Furthermore, the statisticians conducting the data analysis will maintain blinding during the analysis phase, with datasets identified solely as Group A and Group B to ensure unbiased evaluation.
入排标准
- 年龄范围
- 18 Years 至 39 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Huanjingjian decoction + Hormone replacement therapy
Participants in this group will receive treatment with Huanjingjian decoction in combination with hormone replacement therapy (HRT).
干预措施: Huanjingjian decoction (Drug)
Huanjingjian decoction + Hormone replacement therapy
Participants in this group will receive treatment with Huanjingjian decoction in combination with hormone replacement therapy (HRT).
干预措施: Hormone replacement therapy (Drug)
Placebo + Hormone replacement therapy
Participants in this group will receive treatment with hormone replacement therapy (HRT) in combination with placebo.
干预措施: Hormone replacement therapy (Drug)
Placebo + Hormone replacement therapy
Participants in this group will receive treatment with hormone replacement therapy (HRT) in combination with placebo.
干预措施: Placebo (Drug)
结局指标
主要结局
Disease-Specific Quality of Life Assessment
时间窗: 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.
次要结局
- Changes in serum anti-Müllerian hormone (AMH) levels(From the time of enrollment through the 6-month follow-up period)
- Change in follicle-stimulating hormone (FSH) levels(From the time of enrollment through the 6-month follow-up period)
- Change in luteinizing hormone (LH) levels(From the time of enrollment through the 6-month follow-up period)
- Change in estradiol (E2) levels(From the time of enrollment through the 6-month follow-up period)
- Menstrual recovery rate(From the time of enrollment through the 6-month follow-up period)
- Antral follicle count(From the time of enrollment through the 6-month follow-up period)
- Ovarian volume evaluation(From the time of enrollment through the 6-month follow-up period)
- Generic quality of life(From the time of enrollment through the 6-month follow-up period)
研究者
Wei Wu
Attending Physician, Department of Anesthesiology
Shanghai Pulmonary Hospital, Shanghai, China