Efficacy and Safety of Huanjingjian Decoction in Women With Premature Ovarian Insufficiency (EAST-HOPE)

Shanghai Pulmonary Hospital, Shanghai, China

Status: Begins enrollment this month

Conditions: Premature Ovarian Insufficiency

Treatments: Drug: Huanjingjian decoction; Drug: Hormone replacement therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT07020429

202240223

Details and patient eligibility

About

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.

Full 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.

Enrollment: 276 estimated patients

Sex: Female

Ages: 18 to 39 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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276 participants in 2 patient groups

Huanjingjian decoction + Hormone replacement therapy

Experimental group

Description:

Participants in this group will receive treatment with Huanjingjian decoction in combination with hormone replacement therapy (HRT).

Treatment:

Drug: Hormone replacement therapy

Drug: Huanjingjian decoction

Hormone replacement therapy

Active Comparator group

Description:

Participants in this group will receive treatment with hormone replacement therapy (HRT) alone.

Treatment:

Drug: Hormone replacement therapy