Menopausal SyndromeNCT06874738
A Real-world Clinical Study on the Treatment of Menopausal Syndrome With Liuwei Dihuang Pills
An observational study of Menopausal Syndrome, run by China Academy of Chinese Medical Sciences.
Trial summary
To evaluate the clinical efficacy of the real-world Liuwei Dihuang pills for the treatment of female menopausal syndromes, and to provide a basis for effective, safe and rational clinical use of the drug. Read more about this study
- Who is it for?
- Ages 45 to 55 years, women only
- Conditions the study is for
- Menopausal Syndrome
- What is being tested?
- Liuwei Dihuang pills
- Type of treatment
- Pill or oral medicine
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- 8 Mar 2025to 30 Dec 2026
- Phase
- Observational
- 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 45 to 55 years
- Women only
- No healthy volunteers
- Adult
Study population: Menopausal syndrome refers to a series of physical and psychosomatic symptoms caused by the gradual decline of ovarian function and fluctuating or decreasing levels of sex hormones before and after menopause in women.
Who may be able to join
- Age: 45-55 years old
- Patients with menopausal syndrome using Liuwei Dihuang Pills
- Kidney Yin Deficiency Syndrome
Who cannot join
- Individuals allergic to any components of the drug or excipients;
- Individuals with other endocrine diseases;
- Individuals with organic lesions of the reproductive system;
- Individuals who have undergone bilateral oophorectomy, hysterectomy, or have ovarian dysfunction;
- Individuals with endometrial hyperplasia or unexplained vaginal bleeding;
- Individuals with malignant tumors, hematologic, or immune system diseases;
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- Individuals with severe cardiovascular, cerebrovascular, liver, or kidney diseases (e.g., serum transaminase levels more than 1.5 times the upper limit of normal, serum creatinine above the upper limit of normal);
- Individuals with psychiatric disorders or dependence on alcohol or drugs;
- Individuals with mental illness or communication barriers;
- Individuals with other conditions that, in the investigator's judgment, may reduce the likelihood of enrollment or complicate the study process are not suitable for participation in this clinical research.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
To evaluate the clinical efficacy of the real-world Liuwei Dihuang pills for the treatment of female menopausal syndromes, and to provide a basis for effective, safe and rational clinical use of the drug.
Read the detailed description
In this study, the patients were divided into exposed and non-exposed groups based on whether or not they were taking Liuwei Dihuang Pills.
The patients in the non-exposed group were treated routinely, and the patients in the exposed group were treated routinely + Liuwei Dihuang Pills. The patients in the exposed group were required to take the medication according to the dosage instructions for at least 4 consecutive weeks. Combined use of drugs is allowed without interfering with the treatment plan, and the use of drugs and combined use of drugs should be recorded truthfully, including the dose, duration, frequency, and so on. The type of drugs used in combination and the corresponding daily dose, daily frequency and duration of treatment. During the course of treatment, patients in both groups were required to receive follow-up assessment once every 4 weeks. Termination of the study included death, loss of patients, or achievement of study endpoints.
- Conditions
- Menopausal Syndrome
- Being tested
- Liuwei Dihuang pills
- Keywords
- Liuwei Dihuang Pills, The real world, Efficacy, Clinical study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liuwei Dihuang pillsDrug
Conventional treatment （Hormones, selective 5-hydroxytryptamine reuptake inhibitors, etc.）+ Liu Wei Di Huang Pills
| Study group | Role | What they receive |
|---|---|---|
| Liuwei Dihuang Pills | The intervention in this cohort consisted of the Six-flavoured Dihuang Pill and the rest of the conventional treatment. Receives: Drug: Liuwei Dihuang pills |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Menopausal Symptoms
The Kupperman Rating Scale is a global tool for assessing menopausal symptoms. It has 13 items covering common perimenopausal symptoms like hot flashes, sweating, paresthesia, insomnia, irritability, depression, dizziness, fatigue, arthralgia, headache, palpitations, formication, urinary infections, and sexual status. Each item is weighted and summed for a total score of 0-63. A lower score means more severe perimenopausal symptoms.The modified Kupperman Rating Scale will be used to assess menopausal symptoms. Participants will complete the questionnaire before, after treatment, and during follow-up. Researchers will calculate the total score.
Measured: 4 weeks
Change of Hormone Levels
Sex hormone levels are key for evaluating the endocrine status of menopausal women. In patients with menopausal syndrome, sex hormone levels show elevated Follicle-Stimulating Hormone and Luteinizing Hormone, and reduced Estradiol. High Follicle-Stimulating Hormone points to ovarian dysfunction. Changes in the Luteinizing Hormone/Follicle-Stimulating Hormone ratio may be linked to polycystic ovary syndrome, and decreased Estradiol is associated with ovarian failure.
Measured: 4 weeks
Secondary outcomes (2)
Change of Quality in life
The Menopause-Specific Quality of Life Questionnaire assesses menopausal women's quality of life, covering four dimensions: vasomotor symptoms, psychosocial state, physical state, and sexual life, with 29 items in total. Each item is scored from 0 to 6, where 0 means no distress and 6 means extreme distress. The average score of items in each dimension is calculated. A higher score indicates lower quality of life in that dimension.
Measured: 4 weeks
Change of TCM Syndrome Scores
The TCM syndrome score sheet, designed as per TCM theory, assesses menopausal patients' TCM syndromes, covering symptoms and signs inTCM, etc.Changes in TCM syndrome scores for menopausal syndrome reflect improvement or worsening. The scale uses a semi - quantitative grading method, assigning scores of 0, 1, 2, or 3 to represent the severity of symptoms in menopausal syndrome patients. The scores are added up to form the total syndrome score, with a minimum of 0 and a maximum of 42. A higher score means a more serious condition.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2025
- Study start8 Mar 2025 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Menopausal SyndromeStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Lanxi Hospital of Traditional Chinese Medicine, First Affiliated Hospital of Harbin Medical University
- Responsible party
- Principal investigator, Lianxin Wang, China Academy of Chinese Medical Sciences
- Investigators
- Lianxin Wang, Principal investigator, Institute of Basic Research in Clinical Medicine, China Academy of Chinese
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06874738
- Sponsor's protocol ID
- Liuwei Dihuang Pills
- Status last verified
- Mar 2025
- First submitted
- 14 Feb 2025
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wei S, Zhang H, Wang M, Sun Y, Song T, Zheng W, Ye Y, Ma L, Yang Y, Wei T, Cheng L, Sun C, Ding X, Zhao S, Song Q, Wang L. Real-World Effectiveness and Safety of Liuwei Dihuang Pill for Menopausal Syndrome: Protocol for a Prospective, Observational, Multicenter Cohort Study. JMIR Res Protoc. 2026 Mar 25;15:e84803. doi: 10.2196/84803.
PubMed 41879810
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real-world Clinical Study on the Treatment of Menopausal Syndrome With Liuwei Dihuang Pills
- ClinicalTrials.gov ID
- NCT06874738
- Acronym / sponsor ID
- Liuwei Dihuang Pills
- Conditions
- Menopausal Syndrome
- Keywords
- Liuwei Dihuang Pills, The real world, Efficacy, Clinical study
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- China Academy of Chinese Medical SciencesUniversity, hospital or other
- Collaborators
- Lanxi Hospital of Traditional Chinese Medicine, First Affiliated Hospital of Harbin Medical University
- Study start
- 8 Mar 2025 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 13 Mar 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.
To evaluate the clinical efficacy of the real-world Liuwei Dihuang pills for the treatment of female menopausal syndromes, and to provide a basis for effective, safe and rational clinical use of the drug.
Detailed description
In this study, the patients were divided into exposed and non-exposed groups based on whether or not they were taking Liuwei Dihuang Pills.
The patients in the non-exposed group were treated routinely, and the patients in the exposed group were treated routinely + Liuwei Dihuang Pills. The patients in the exposed group were required to take the medication according to the dosage instructions for at least 4 consecutive weeks. Combined use of drugs is allowed without interfering with the treatment plan, and the use of drugs and combined use of drugs should be recorded truthfully, including the dose, duration, frequency, and so on. The type of drugs used in combination and the corresponding daily dose, daily frequency and duration of treatment. During the course of treatment, patients in both groups were required to receive follow-up assessment once every 4 weeks. Termination of the study included death, loss of patients, or achievement of study endpoints.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Liuwei Dihuang Pills | – | Drug: Liuwei Dihuang pillsThe intervention in this cohort consisted of the Six-flavoured Dihuang Pill and the rest of the conventional treatment. |
Who may qualify
- Ages
- 45 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Menopausal syndrome refers to a series of physical and psychosomatic symptoms caused by the gradual decline of ovarian function and fluctuating or decreasing levels of sex hormones before and after menopause in women.
Key inclusion criteria (3 listed)
- Age: 45-55 years old
- Patients with menopausal syndrome using Liuwei Dihuang Pills
- Kidney Yin Deficiency Syndrome
Key exclusion criteria (10 listed)
- Individuals allergic to any components of the drug or excipients;
- Individuals with other endocrine diseases;
- Individuals with organic lesions of the reproductive system;
- Individuals who have undergone bilateral oophorectomy, hysterectomy, or have ovarian dysfunction;
- Individuals with endometrial hyperplasia or unexplained vaginal bleeding;
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 |
|---|---|---|
| Liuwei Dihuang pillsConventional treatment （Hormones, selective 5-hydroxytryptamine reuptake inhibitors, etc.）+ Liu Wei Di Huang Pills | Drug | Liuwei Dihuang Pills |
Primary outcome
Change of Menopausal Symptoms
Time frame: 4 weeks
The Kupperman Rating Scale is a global tool for assessing menopausal symptoms. It has 13 items covering common perimenopausal symptoms like hot flashes, sweating, paresthesia, insomnia, irritability, depression, dizziness, fatigue, arthralgia, headache, palpitations, formication, urinary infections, and sexual status. Each item is weighted and summed for a total score of 0-63. A lower score means more severe perimenopausal symptoms.The modified Kupperman Rating Scale will be used to assess menopausal symptoms. Participants will complete the questionnaire before, after treatment, and during follow-up. Researchers will calculate the total score.
Change of Hormone Levels
Time frame: 4 weeks
Sex hormone levels are key for evaluating the endocrine status of menopausal women. In patients with menopausal syndrome, sex hormone levels show elevated Follicle-Stimulating Hormone and Luteinizing Hormone, and reduced Estradiol. High Follicle-Stimulating Hormone points to ovarian dysfunction. Changes in the Luteinizing Hormone/Follicle-Stimulating Hormone ratio may be linked to polycystic ovary syndrome, and decreased Estradiol is associated with ovarian failure.
2 secondary outcomes
Change of Quality in life
Time frame: 4 weeks
Change of TCM Syndrome Scores
Time frame: 4 weeks
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 13 Mar 2025.
- Derived from this study: PubMed 41879810Wei S, Zhang H, Wang M, Sun Y, Song T, Zheng W, Ye Y, Ma L, Yang Y, Wei T, Cheng L, Sun C, Ding X, Zhao S, Song Q, Wang L. Real-World Effectiveness and Safety of Liuwei Dihuang Pill for Menopausal Syndrome: Protocol for a Prospective, Observational, Multicenter Cohort Study. JMIR Res Protoc. 2026 Mar 25;15:e84803. doi: 10.2196/84803.
- Individual participant dataSharing planned: No
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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.
Lianxin Wang principal investigator
Institute of Basic Research in Clinical Medicine, China Academy of Chinese
Questions about this trial
What is this clinical trial studying?
An observational study of Menopausal Syndrome, run by China Academy of Chinese Medical Sciences.
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 3 inclusion and 10 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 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Lianxin Wang (86-13521781839, wlxing2022@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Menopausal Symptoms (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06874738, which also lists 1 linked publication.
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 13 Mar 2025.