Premature Ovarian InsufficiencyEAST-HOPENCT07020429
Efficacy and Safety of Huanjingjian Decoction in Women With Premature Ovarian Insufficiency
A study testing Huanjingjian decoction and Hormone replacement therapy in people with Premature Ovarian Insufficiency, run by Shanghai Pulmonary Hospital, Shanghai, China at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 39 years, women only
- Conditions the study is for
- Premature Ovarian Insufficiency
- What is being tested?
- Huanjingjian decoction and Hormone replacement therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 276 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2025to 30 Jul 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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);
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- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Jingan hospital of Traditional Chinese Medicine
Shanghai
JIANGHONG XU, 021-13918909977, Jianghongxu@shutcm.edu.cn
JIANGHONG XU
About this study
Official title: Efficacy and Safety of the Traditional Chinese Herbal Formula Huanjingjian Decoction in Women With Premature Ovarian Insufficiency: a Randomised Controlled Trial
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:
Read more
- Does Huanjingjian decoction improve clinical symptoms in patients with POI?
- 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.
Read the detailed description
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.
- Conditions
- Premature Ovarian Insufficiency
- Being tested
- Huanjingjian decoction, Hormone replacement therapy, Placebo
- Keywords
- premature ovarian insufficiency, menopause, traditional Chinese herbal formula, Huanjingjian decoction
- Medical subject headings
- Primary Ovarian Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Huanjingjian decoctionDrug
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 therapyDrug
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.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Huanjingjian decoction + Hormone replacement therapy | Experimental | Participants in this group will receive treatment with Huanjingjian decoction in combination with hormone replacement therapy (HRT). Receives: 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. Receives: Drug: Hormone replacement therapy; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From the time of enrollment through the 6-month follow-up period
Secondary outcomes (8)
Changes in serum anti-Müllerian hormone (AMH) levels
Assessments will be conducted at baseline, 3 months, and 6 months, with measurements taken on day 3 of the menstrual cycle.
Measured: From the time of enrollment through the 6-month follow-up period
Change in follicle-stimulating hormone (FSH) levels
Assessments will be conducted at baseline, 3 months, and 6 months, with measurements taken on day 3 of the menstrual cycle.
Measured: From the time of enrollment through the 6-month follow-up period
Change in luteinizing hormone (LH) levels
Assessments will be conducted at baseline, 3 months, and 6 months, with measurements taken on day 3 of the menstrual cycle.
Measured: From the time of enrollment through the 6-month follow-up period
Change in estradiol (E2) levels
Assessments will be conducted at baseline, 3 months, and 6 months, with measurements taken on day 3 of the menstrual cycle.
Measured: From the time of enrollment through the 6-month follow-up period
Antral follicle count
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.
Measured: From the time of enrollment through the 6-month follow-up period
Ovarian volume evaluation
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.
Measured: From the time of enrollment through the 6-month follow-up period
Menstrual recovery rate
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.
Measured: From the time of enrollment through the 6-month follow-up period
Generic quality of life
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.
Measured: From the time of enrollment through the 6-month follow-up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2025
- Study start1 Sep 2025 (estimated)
- Primary completion30 Jul 2030 (estimated)
- Study completion30 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature Ovarian InsufficiencyStudies of the same condition, open and under way.
- More trials run by Shanghai Pulmonary Hospital, Shanghai, ChinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 276 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, China
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai University of Traditional Chinese Medicine, Shanghai Geriatric Institute of Chinese Medicine, Shanghai Institute of Acupuncture and Anesthesia, Shanghai, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Jingan Hospital of Traditional Chinese Medicine
- Responsible party
- Principal investigator, Wei Wu, Shanghai Pulmonary Hospital, Shanghai, China
- Investigators
- TE LIU, Doctor, Study chair, Shanghai Geriatric Institute of Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07020429
- Sponsor's protocol ID
- 202240223
- Acronym
- EAST-HOPE
- Status last verified
- Sep 2025
- First submitted
- 16 May 2025
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Primary outcome data under request
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of the Traditional Chinese Herbal Formula Huanjingjian Decoction in Women With Premature Ovarian Insufficiency: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT07020429
- Acronym / sponsor ID
- EAST-HOPE / 202240223
- Conditions
- Premature Ovarian Insufficiency
- Keywords
- premature ovarian insufficiency, menopause, traditional Chinese herbal formula, Huanjingjian decoction
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 276 participants (estimated)
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, ChinaUniversity, hospital or other
- Collaborators
- Shanghai University of Traditional Chinese Medicine, Shanghai Geriatric Institute of Chinese Medicine, Shanghai Institute of Acupuncture and Anesthesia, Shanghai, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Jingan Hospital of Traditional Chinese Medicine
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 30 Jul 2030 (estimated)
- Study completion
- 30 Jul 2030 (estimated)
- First posted
- 13 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does Huanjingjian decoction improve clinical symptoms in patients with POI?
- 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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Huanjingjian decoction + Hormone replacement therapy | Experimental | Drug: Huanjingjian decoction, Drug: Hormone replacement therapyParticipants in this group will receive treatment with Huanjingjian decoction in combination with hormone replacement therapy (HRT). |
| Placebo + Hormone replacement therapy | Active comparator | Drug: Hormone replacement therapy, Drug: PlaceboParticipants in this group will receive treatment with hormone replacement therapy (HRT) in combination with placebo. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Huanjingjian decoctionParticipants 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. | Drug | Huanjingjian decoction + Hormone replacement therapy |
| Hormone replacement therapyParticipants 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. | Drug | Huanjingjian decoction + Hormone replacement therapy, Placebo + Hormone replacement therapy |
| PlaceboParticipants 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. | Drug | Placebo + Hormone replacement therapy |
Primary outcome
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.
8 secondary outcomes
Changes in serum anti-Müllerian hormone (AMH) levels
Time frame: From the time of enrollment through the 6-month follow-up period
Change in follicle-stimulating hormone (FSH) levels
Time frame: From the time of enrollment through the 6-month follow-up period
Change in luteinizing hormone (LH) levels
Time frame: From the time of enrollment through the 6-month follow-up period
Change in estradiol (E2) levels
Time frame: From the time of enrollment through the 6-month follow-up period
Antral follicle count
Time frame: From the time of enrollment through the 6-month follow-up period
Ovarian volume evaluation
Time frame: From the time of enrollment through the 6-month follow-up period
Menstrual recovery rate
Time frame: From the time of enrollment through the 6-month follow-up period
Generic quality of life
Time frame: From the time of enrollment through the 6-month follow-up period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- Individual participant dataSharing planned: Yes. Primary outcome data under request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
TE LIU, Doctor study chair
Shanghai Geriatric Institute of Chinese Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Huanjingjian decoction and Hormone replacement therapy in people with Premature Ovarian Insufficiency, run by Shanghai Pulmonary Hospital, Shanghai, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact WEI WU (021-18019285297, wuwei19900112@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-Specific Quality of Life Assessment (time frame: From the time of enrollment through the 6-month follow-up period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2025.