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

Официальное название

Efficacy and Safety of the Traditional Chinese Herbal Formula Huanjingjian Decoction in Women With Premature Ovarian Insufficiency: a Randomised Controlled Trial

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат Huanjingjian decoction
  Participants 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
• Препарат Hormone replacement therapy
  Participants 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.
• Препарат Placebo
  Participants 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.

Первичные конечные точки

• Disease-Specific Quality of Life Assessment [Срок оценки: From the time of enrollment through the 6-month follow-up period]

Вторичные конечные точки (8)

• Changes in serum anti-Müllerian hormone (AMH) levels [Срок оценки: From the time of enrollment through the 6-month follow-up period]
• Change in follicle-stimulating hormone (FSH) levels [Срок оценки: From the time of enrollment through the 6-month follow-up period]
• Change in luteinizing hormone (LH) levels [Срок оценки: From the time of enrollment through the 6-month follow-up period]
• Change in estradiol (E2) levels [Срок оценки: From the time of enrollment through the 6-month follow-up period]
• Antral follicle count [Срок оценки: From the time of enrollment through the 6-month follow-up period]
• Ovarian volume evaluation [Срок оценки: From the time of enrollment through the 6-month follow-up period]
• Menstrual recovery rate [Срок оценки: From the time of enrollment through the 6-month follow-up period]
• Generic quality of life [Срок оценки: From the time of enrollment through the 6-month follow-up period]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Jingan hospital of Traditional Chinese Medicine — Шанхай

Идентификаторы

NCT: NCT07020429 · 202240223

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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