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NCT Number: NCT07020429

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

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.

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Key information

Conditions

Premature Ovarian Insufficiency Adnexal Diseases Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Ovarian Diseases Primary Ovarian Insufficiency Urogenital Diseases

Age range

18 year–39 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Jingan hospital of Traditional Chinese Medicine

Shanghai, China

Location contact

JIANGHONG XU

CONTACT

[email protected]

021-13918909977

JIANGHONG XU

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. Disease-Specific Quality of Life Assessment

    Time frame: 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.

Secondary outcomes

  1. Changes in serum anti-Müllerian hormone (AMH) levels

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

    Assessments will be conducted at baseline, 3 months, and 6 months, with measurements taken on day 3 of the menstrual cycle.

  2. Change in follicle-stimulating hormone (FSH) levels

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

    Assessments will be conducted at baseline, 3 months, and 6 months, with measurements taken on day 3 of the menstrual cycle.

  3. Change in luteinizing hormone (LH) levels

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

    Assessments will be conducted at baseline, 3 months, and 6 months, with measurements taken on day 3 of the menstrual cycle.

  4. Change in estradiol (E2) levels

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

    Assessments will be conducted at baseline, 3 months, and 6 months, with measurements taken on day 3 of the menstrual cycle.

  5. Antral follicle count

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

    Antral follicle count (AFC) will be assessed by transvaginal ultrasound between days 2 and 5 of the menstrual cycle at baseline, 3 months, and 6 months. Menstruation may be spontaneous or induced with progestin; in cases of persistent amenorrhea, ovarian function assessment will be performed irrespective of the menstrual cycle.

  6. Ovarian volume evaluation

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

    Ovarian volume evaluation will be assessed by transvaginal ultrasound between days 2 and 5 of the menstrual cycle at baseline, 3 months, and 6 months. Menstruation may be spontaneous or induced with progestin; in cases of persistent amenorrhea, ovarian function assessment will be performed irrespective of the menstrual cycle.

  7. Menstrual recovery rate

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

    The menstrual recovery rate (%) will be calculated as follows: Menstrual Recovery Rate (%) = (Number of participants with menstrual recovery ÷ Total number of participants) × 100%. Assessment of this outcome will be conducted at 6 months.

  8. Generic quality of life

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

    Generic quality of life will be assessed using the Short Form-36 Health Survey (SF-36) at baseline, 3 months, and 6 months to evaluate the overall impact of the intervention on health-related quality of life. The SF-36 is a validated and widely used instrument comprising eight domains: physical functioning, role limitations due to physical or emotional problems, bodily pain, general health, vitality, social functioning, and mental health. Scores range from 0 to 100, with higher scores indicating better perceived health status.

Other outcomes

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

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

    All adverse events occurring throughout the intervention and follow-up periods will be recorded.

  2. Morisky Medication Adherence Scale (MMAS-8)

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

    The Morisky Medication Adherence Scale (MMAS-8) is a widely used self-reported questionnaire designed to assess patients' medication adherence. The scale consists of 8 items, with a total score ranging from 0 to 8. Higher scores indicate better adherence. A score of 8 indicates high adherence, scores of 6-7 indicate medium adherence, and scores below 6 indicate low adherence. The assessment will be conducted at 6 months.

Study contacts

Contact information is provided by the study sponsor or research team.

WEI WU

CONTACT

[email protected]

021-18019285297

Sponsors and collaborators

Lead sponsor

Shanghai Pulmonary Hospital, Shanghai, China

Other

Collaborators

  • Jingan Hospital of Traditional Chinese Medicine
  • Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
  • Shanghai Geriatric Institute of Chinese Medicine
  • Shanghai Institute of Acupuncture and Anesthesia, Shanghai
  • Shanghai University of Traditional Chinese Medicine

Registry information

Official study title

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

Acronym: EAST-HOPE

Important dates

Study start
2025
Primary completion
2030
Study completion
2030
First posted
Jun 13, 2025
Registry last updated
Sep 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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