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

NCT07020429 | Not Yet Recruiting DMC

• 1 other identifier: 202240223
• Study Type: interventional
• Target: 276
• Locations: 1 country
• Sites: 1

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. 1.Does Huanjingjian decoction improve clinical symptoms in patients with POI?
2. 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.

Conditions

Premature Ovarian Insufficiency

Keywords

premature ovarian insufficiency; menopause; traditional Chinese herbal formula; Huanjingjian decoction

Outcome Measures

Primary Outcomes (1)

• Disease-Specific Quality of Life Assessment

  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.

  From the time of enrollment through the 6-month follow-up period

Secondary Outcomes (8)

• 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

• Antral follicle count

  From the time of enrollment through the 6-month follow-up period

Other Outcomes (2)

• Number of participants with adverse events as assessed by CTCAE v4.0 （Safety Outcome）

  From the time of enrollment through the 6-month follow-up period

• Morisky Medication Adherence Scale (MMAS-8)

  From the time of enrollment through the 6-month follow-up period

Study Arms (2)

Huanjingjian decoction + Hormone replacement therapy

EXPERIMENTAL

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

Drug: Huanjingjian decoction; Drug: Hormone replacement therapy

Placebo + Hormone replacement therapy

ACTIVE COMPARATOR

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

Drug: Hormone replacement therapy; Drug: Placebo

Interventions

Huanjingjian decoction DRUG

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 administered.

Huanjingjian decoction + Hormone replacement therapy

Hormone replacement therapy DRUG

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.

Huanjingjian decoction + Hormone replacement therapy; Placebo + Hormone replacement therapy

Placebo DRUG

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.

Placebo + Hormone replacement therapy

Eligibility Criteria

• Age: 18 Years - 39 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Pulmonary Hospital, Shanghai, China: lead
• Shanghai University of Traditional Chinese Medicine: collaborator
• Shanghai Geriatric Institute of Chinese Medicine: collaborator
• Shanghai Institute of Acupuncture and Anesthesia, Shanghai: collaborator
• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine: collaborator
• Jingan Hospital of Traditional Chinese Medicine: collaborator

Study Sites (1)

Jingan hospital of Traditional Chinese Medicine

Shanghai, China

Location

MeSH Terms

Conditions

Primary Ovarian Insufficiency

Interventions

Hormone Replacement Therapy

Condition Hierarchy (Ancestors)

Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Officials

• TE LIU, Doctor

  Shanghai Geriatric Institute of Chinese Medicine

  STUDY CHAIR

Central Study Contacts

WEI WU

CONTACT

021-18019285297; wuwei19900112@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician, Department of Anesthesiology

Study Record Dates

• First Submitted: May 16, 2025
• First Posted: June 13, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): July 30, 2030
• Study Completion (Estimated): July 30, 2030
• Last Updated: September 8, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: From publication until the third year after publication
• Access Criteria: Research scope

Locations

CN (1)