MenopausePhase 2NCT06074809

RCT on the Treatment of Menopausal Syndrome With Chinese Medicine

A Phase 2 study testing Modified Guizhi Fuling granules in people with Menopause, run by Chinese University of Hong Kong at 1 site in Hong Kong.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

This is a double-blinded, randomized, placebo-controlled clinical trial. Subjects will be randomly assigned to the treatment group (Modified Guizhi Fuling granules) or placebo group (Placebo granules) for 8 weeks. Outcomes will be measured at week 8 and week 12. Read more about this study

Who is it for?: Ages 40 to 60 years, women only
Conditions the study is for: Menopause
What is being tested?: Modified Guizhi Fuling granules
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 78 participants
Where: 1 siteHong Kong
Study dates: 1 Nov 2023to 31 Jan 2026
Phase: Phase 2
Are there results?: None posted in the registry

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 40 to 60 years
Women only
No healthy volunteers
Adult

Who may be able to join

Female subjects with age between 40 and 60 years old;
For those who have symptoms of primary menopause (irregular menstruation lasting for more than 6 months, or absence of menstrual periods for more than 3 months)
The score of the physical symptoms in Greene Climacteric Symptom Score (GCS) is 6 or above (average level);
Have moderate level (affecting certain level of daily activity) or severe (cannot carry out daily activity) hot flashes, defined as transient sensations of heat, sweating, flushing, anxiety and chills lasting for 1-5 minutes;
Diagnosed Deficiency of Kidney essence and static blood in Lower Jiao by Chinese medicine practitioner
Agreed to receive Chinese medication or placebo for 2 months upon randomization.

Who cannot join

The menopausal syndrome caused by surgical operations or medications (such as chemotherapy, gonadotropin-releasing hormone agonists, etc.).
Have received estrogen treatment in the past 2 months;
Have received any medication for treating menopause in the past month, including herbs, non-prescribed drugs, supplements, or change of diet to consume more legumes;
Known serious emotional, mental or psychological disorders that may affect the study;
During pregnancy, pre-pregnancy period, or lactation period;
Known history of allergy to any traditional Chinese medicine;

Show all 9Show fewer

Have received anticoagulant or antiplatelet drugs in the past month;
Known history of some certain serious medical disease, such as cardiovascular disease, liver or renal dysfunction, diabetes, cerebrovascular disease, blood disorders, with unstable conditions;
Chinese medicine pattern combined with damp phlegm or damp heat, or only deficiency of Yin blood or absence of static blood pattern.

Trial locations and contacts

1 site in 1 country.

Hongwei Zhang, PhD contact

Cho Wing Lo contact

Hong Kong1 site

School of Chinese Medicine
Shatin

Other trials in Hong Kong

About this study

Official title: Clinical Trial on the Treatment of Menopausal Syndrome With Chinese Medicine Gui-zhi-fu-ling-wan With Variation and the Mechanism of Anti-inflammation and Body Surface Temperature Distribution

Read the detailed description

Menopausal syndrome is a series of symptoms caused by ovarian follicles degeneration that occurs before or after menopause. These symptoms include central nervous system-related disorders (such as hot flashes, insomnia, depression, anxiety, etc.); metabolic, weight, cardiovascular and musculoskeletal changes; urogenital and skin atrophy; and sexual dysfunction.

Some previous studies have investigated the possibilities of using traditional Chinese medicine (TCM) for the treatment of menopausal syndrome. However, due to the limitations of previous clinical research, more evidence is required to support the efficacy of TCM treatment. Therefore, we propose to conduct a randomized, double-blinded, placebo-controlled clinical trial here, with the hope of objectively assessing the efficacy and safety of using TCM to treat menopausal syndrome.

Conditions: Menopause
Being tested: Modified Guizhi Fuling granules, Placebo
Keywords: Traditional Chinese medicine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Modified Guizhi Fuling granulesDrug
Also called Chinese medicine
Modified Guizhi Fuling granules will be orally administered to patients in the TCM treatment group twice a day throughout the treatment period, which lasts for 8 weeks.
PlaceboOther
Placebo will be orally administered to patients in the placebo group twice a day throughout the treatment period, which lasts for 8 weeks.

Study groups in NCT06074809
Study group	Role	What they receive
Traditional Chinese medicine treatment group	Experimental	Chinese medicine will be administered to patients in this group. Receives: Drug: Modified Guizhi Fuling granules
Placebo group	Placebo comparator	Placebo will be administered to patients in this group. Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Greene Climacteric Scale (Chinese version)
Greene Climacteric Scale (GCS) is one of the most common scales used to assess menopause. It includes four aspects of symptoms: vasomotor, somatic, psychological, and sexual response. This scale consists of 21 symptoms that can be assessed by patients themselves. The scoring from 0 to 3 in each item, indicates 'Not at all', 'A little bit', 'Much', and 'Very much' respectively.
Measured: Week 8

Secondary outcomes (9)

Short-Form Health Survey, SF-12v2 (Chinese version)
The SF-12v2 is the brief version of SF-36, consisting of 12 questions related to our physical, mental health and functionality. It is used as a supportive tool to comprehensively assess the health status of the patient. Scores range from 0 to 100, with higher scores representing better self-reported health.
Measured: Week 8
Short-Form Health Survey, SF-12v2 (Chinese version)
The SF-12v2 is the brief version of SF-36, consisting of 12 questions related to our physical, mental health and functionality. It is used as a supportive tool to comprehensively assess the health status of the patient. Scores range from 0 to 100, with higher scores representing better self-reported health.
Measured: Week 12
Temperature change of face, limbs and abdomen
The peripheral temperature of the face, limbs and abdomen of the patients will be measured by a thermographic camera.
Measured: Week 8
Temperature change of face, limbs and abdomen
The peripheral temperature of the face, limbs and abdomen of the patients will be measured by a thermographic camera.
Measured: Week 12
Level change of sex hormones
Level change of Estradiol (E2) and Follicle-stimulating hormone (FSH) will be measured between baseline and week 8.
Measured: Week 8
Level change of sex hormones
Level change of Estradiol (E2) and Follicle-stimulating hormone (FSH) will be measured between baseline and week 12.
Measured: Week 12
Level change of inflammatory markers
Level change of the serum inflammatory factors: high-sensitivity C-reactive protein (hsCRP), Interleukin 6 (IL-6) , Interleukin 8 (IL-8) and Tumor necrosis factor-α (TNF-α) will be measured from baseline to week 8.
Measured: Week 8
Level change of inflammatory markers
Level change of the serum inflammatory factors: high-sensitivity C-reactive protein (hsCRP), Interleukin 6 (IL-6) , Interleukin 8 (IL-8) and Tumor necrosis factor-α (TNF-α) will be measured from baseline to week 12.
Measured: Week 12
Greene Climacteric Scale (Chinese version)
Greene Climacteric Scale (GCS) is one of the most common scales used to assess menopause. It includes four aspects of symptoms: vasomotor, somatic, psychological, and sexual response. This scale consists of 21 symptoms that can be assessed by patients themselves. The scoring from 0 to 3 in each item, indicates 'Not at all', 'A little bit', 'Much', and 'Very much' respectively.
Measured: Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Nov 202331 Jan 2026

First posted10 Oct 2023
Study start1 Nov 2023 (estimated)
Primary completion31 Oct 2025 (estimated)
Study completion31 Jan 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for MenopauseStudies of the same condition, open and under way.
More trials run by Chinese University of Hong KongThe 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 78 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06074809
Sponsor's protocol ID: Menopause study
Status last verified: Oct 2023
First submitted: 4 Oct 2023
Last updated: 10 Oct 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

Hongwei Zhang, PhD

39439845

zhanghw@cuhk.edu.hk

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Effect of Hormone Replacement Therapy on Physiotherapy Outcomes in Postmenopausal Women With Frozen Shoulder
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RecruitingObservational study
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All Menopause trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Trial on the Treatment of Menopausal Syndrome With Chinese Medicine Gui-zhi-fu-ling-wan With Variation and the Mechanism of Anti-inflammation and Body Surface Temperature Distribution
ClinicalTrials.gov ID: NCT06074809
Acronym / sponsor ID: Menopause study
Conditions: Menopause
Keywords: Traditional Chinese medicine
Phase: Phase 2
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 78 participants (estimated)
Lead sponsor: Chinese University of Hong KongUniversity, hospital or other
Study start: 1 Nov 2023 (estimated)
Primary completion: 31 Oct 2025 (estimated)
Study completion: 31 Jan 2026 (estimated)
First posted: 10 Oct 2023 (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.

Detailed description

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
Traditional Chinese medicine treatment group	Experimental	Drug: Modified Guizhi Fuling granulesChinese medicine will be administered to patients in this group.
Placebo group	Placebo comparator	Other: PlaceboPlacebo will be administered to patients in this group.

Who may qualify

Ages: 40 to 60 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (6 listed)

Female subjects with age between 40 and 60 years old;
For those who have symptoms of primary menopause (irregular menstruation lasting for more than 6 months, or absence of menstrual periods for more than 3 months)
The score of the physical symptoms in Greene Climacteric Symptom Score (GCS) is 6 or above (average level);
Have moderate level (affecting certain level of daily activity) or severe (cannot carry out daily activity) hot flashes, defined as transient sensations of heat, sweating, flushing, anxiety and chills lasting for 1-5 minutes;
Diagnosed Deficiency of Kidney essence and static blood in Lower Jiao by Chinese medicine practitioner

Key exclusion criteria (9 listed)

The menopausal syndrome caused by surgical operations or medications (such as chemotherapy, gonadotropin-releasing hormone agonists, etc.).
Have received estrogen treatment in the past 2 months;
Have received any medication for treating menopause in the past month, including herbs, non-prescribed drugs, supplements, or change of diet to consume more legumes;
Known serious emotional, mental or psychological disorders that may affect the study;
During pregnancy, pre-pregnancy period, or lactation period;

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
Modified Guizhi Fuling granulesAlso: Chinese medicineModified Guizhi Fuling granules will be orally administered to patients in the TCM treatment group twice a day throughout the treatment period, which lasts for 8 weeks.	Drug	Traditional Chinese medicine treatment group
PlaceboPlacebo will be orally administered to patients in the placebo group twice a day throughout the treatment period, which lasts for 8 weeks.	Other	Placebo group

Primary outcome

Greene Climacteric Scale (Chinese version)
Time frame: Week 8
Greene Climacteric Scale (GCS) is one of the most common scales used to assess menopause. It includes four aspects of symptoms: vasomotor, somatic, psychological, and sexual response. This scale consists of 21 symptoms that can be assessed by patients themselves. The scoring from 0 to 3 in each item, indicates 'Not at all', 'A little bit', 'Much', and 'Very much' respectively.

9 secondary outcomes

Short-Form Health Survey, SF-12v2 (Chinese version)
Time frame: Week 8
Short-Form Health Survey, SF-12v2 (Chinese version)
Time frame: Week 12
Temperature change of face, limbs and abdomen
Time frame: Week 8
Temperature change of face, limbs and abdomen
Time frame: Week 12
Level change of sex hormones
Time frame: Week 8
Level change of sex hormones
Time frame: Week 12
Level change of inflammatory markers
Time frame: Week 8
Level change of inflammatory markers
Time frame: Week 12
Greene Climacteric Scale (Chinese version)
Time frame: Week 12

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.

Related trials for Menopause

Recruiting
Hop Extract Versus Soy Isoflavone Extract for Menopausal Symptoms (HOPES)
Menopause, Perimenopause
Not yet recruiting
The Role of Diet Quality in Sleep Among Women in Postmenopause
Post Menopausal Women
Active, not recruitingPhase 3
Human Menopausal Gonadotropin Research in Infertility Assessing Cumulative Live Birth With Frozen Embryo Transfer.
Infertility (IVF Patients)
Not yet recruiting
Effect of Hormone Replacement Therapy on Physiotherapy Outcomes in Postmenopausal Women With Frozen Shoulder
Frozen Shoulder, Adhesive Capsulitis
RecruitingObservational study
Observational Study of Bone Complications in People With Post-menopausal Breast Cancer Who Have Stopped Treatment With Denosumab and Aromatase Inhibitors
Breast Cancer

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. This study is not recruiting at the moment.

Hongwei Zhang, PhD contact

Cho Wing Lo contact

Hongwei Zhang, PhD principal investigator

School 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 Phase 2 study testing Modified Guizhi Fuling granules in people with Menopause, run by Chinese University of Hong Kong at 1 site in Hong Kong.

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 6 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 10 Oct 2023. 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 Hong Kong. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Hongwei Zhang, PhD (39439845, zhanghw@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Greene Climacteric Scale (Chinese version) (time frame: Week 8). 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 NCT06074809.

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 10 Oct 2023.