Clinical trial NCT07020429: Efficacy and Safety of Huanjingjian Decoction in Women With Premature Ovarian Insufficiency
Official title: Efficacy and Safety of the Traditional Chinese Herbal Formula Huanjingjian Decoction in Women With Premature Ovarian Insufficiency: a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Premature Ovarian Insufficiency
Keywords: premature ovarian insufficiency
menopause
traditional Chinese herbal formula
Huanjingjian decoction
Lead sponsor: Shanghai Pulmonary Hospital, Shanghai, China
Sponsor class: OTHER
Collaborators: name: Shanghai University of Traditional Chinese Medicine
name: Shanghai Geriatric Institute of Chinese Medicine
name: Jing'an District Hospital of Traditional Chinese Medicine
name: Shanghai Institute of Acupuncture and Anesthesia, Shanghai
name: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
First posted: 2025-06-13
Enrollment: 276
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study Summary

This clinical trial aims to evaluate the efficacy and safety of the traditional Chinese herbal formula Huanjingjian decoction in patients with premature ovarian insufficiency (POI). The study focuses on the following key questions:

1. Can Huanjingjian decoction reduce clinical symptoms in patients with POI?
2. What adverse medical events, if any, occur during the treatment with Huanjingjian decoction? Researchers will compare the combination of Huanjingjian decoction plus hormone replacement therapy (HRT) versus HRT alone to determine whether Huanjingjian decoction provides additional therapeutic benefit in treating POI.

Participants will:

1. Receive either Huanjingjian decoction combined with HRT or HRT alone for three treatment cycles, each lasting 28 days.
2. Visit the clinic once monthly for clinical evaluations and laboratory tests.
3. Keep a detailed diary recording symptoms, medication adherence, and menstrual flow assessed by the number of sanitary pads used.

Detailed description: This trial is a prospective, randomized clinical study designed to evaluate the efficacy of the traditional Chinese herbal formula Huanjingjian (HJJ) decoction in combination with hormone replacement therapy (HRT) for the treatment of premature ovarian insufficiency (POI). The primary objective is to determine whether adjunctive therapy with HJJ decoction provides greater improvement in clinical symptoms compared to HRT alone. The investigators hypothesize that, relative to HRT monotherapy, the combination of HJJ decoction and HRT will result in superior clinical outcomes at 12 weeks. A total of 276 patients will be enrolled and randomly assigned in a 1:1 ratio to either the HJJ plus HRT group or the HRT-only group.

Eligibility criteria: 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.

Primary outcomes:
measure: Disease-Specific Quality of Life Assessment
timeFrame: From the time of enrollment through the 6-month follow-up period
Secondary outcomes:
measure: Changes in serum anti-Müllerian hormone (AMH) levels
timeFrame: From the time of enrollment through the 6-month follow-up period
measure: Change in follicle-stimulating hormone (FSH) levels
timeFrame: From the time of enrollment through the 6-month follow-up period
measure: Change in luteinizing hormone (LH) levels
timeFrame: From the time of enrollment through the 6-month follow-up period
measure: Change in estradiol (E2) levels
timeFrame: From the time of enrollment through the 6-month follow-up period
measure: Antral follicle count
timeFrame: From the time of enrollment through the 6-month follow-up period
measure: Ovarian volume evaluation
timeFrame: From the time of enrollment through the 6-month follow-up period
measure: Menstrual recovery rate
timeFrame: From the time of enrollment through the 6-month follow-up period
measure: Generic quality of life
timeFrame: From the time of enrollment through the 6-month follow-up period
Other outcomes:
measure: Number of participants with adverse events as assessed by CTCAE v4.0 （Safety Outcome）
timeFrame: From the time of enrollment through the 6-month follow-up period
measure: Morisky Medication Adherence Scale (MMAS-8)
timeFrame: From the time of enrollment through the 6-month follow-up period
Locations:
city: Shanghai
country: China
facility: Jing'an District Hospital of Traditional Chinese Medicine
Study officials:
affiliation: Shanghai Geriatric Institute of Chinese Medicine
name: TE LIU, Doctor
role: STUDY_CHAIR
References: