Menopausal SyndromeNCT05266079
Comparison Study for Perimenopausal Syndrome With Chinese Herbal Medicine
A study testing Intervention Group in people with Menopausal Syndrome, run by Hong Kong Baptist University at 1 site in Hong Kong.
Trial summary
Background: Perimenopausal syndrome (PMS) refers to a series of symptoms caused by the dynamic fluctuations of sex hormones during menopause. Menopausal symptoms including hot flushes, vaginal dryness and mood swings are experienced by about 80% of Chinese women aged 45 to 60. 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?
- Intervention Group
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteHong Kong
- Study dates
- 14 Mar 2022to 30 Jun 2023
- Phase
- Interventional
- 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 45 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Chinese women aged 45-55 years
- Menstruation abnormalities (menstrual irregularity in past 12 months; or menstrual period off at least twice in past 12 months; or amenorrhea of 2 to 12 months)
- Suffering any of the following perimenopausal symptoms: vasomotor symptoms (hot flushes, sweats), psychological symptoms (insomnia, migraine, irritability), or genitourinary symptoms (vaginal dryness, dyspareunia)
- Did not use hormonal therapy at least 3 months before entry into the study
- Willing to give a written informed consent form to participate in the clinical study
Who cannot join
- Bilateral ovarian resection or pelvic radiotherapy for ovarian cysts and uterine fibroids with a diameter greater than 4 cm
- Unexplained irregular vaginal bleeding
- Suffer from diabetic neuropathy or malignant tumor
- Have used sex hormones in the past 3 months, such as estrogen, progesterone, soy isoflavones etc.
- Patients who have participated in or are participating in other clinical trials in the past 3 months
- Serious primary diseases such as cardiovascular, cerebrovascular, liver, kidney and hematopoietic system
Show all 10Show fewer
- Take sedatives or anti-anxiety drugs regularly
- Smoking or alcohol habits
- Patients with mental illness
- Cannot cooperate with the treatment
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
HKFTU Workers' Medical Clinics - Hong Kong Baptist University Chinese Medicine Clinic cum Training and Research Centre (North District)
Hong Kong
About this study
Official title: Comparison Study of the Effectiveness Between Syndrome Differentiation Treatments and Fixed Formula Treatment for Perimenopausal Syndrome With Chinese Herbal Medicine
Background: Perimenopausal syndrome (PMS) refers to a series of symptoms caused by the dynamic fluctuations of sex hormones during menopause. Menopausal symptoms including hot flushes, vaginal dryness and mood swings are experienced by about 80% of Chinese women aged 45 to 60. In the past year, 235 patients visited CMCTR(ND), a TCM center set up by HA and operated by HKFTU Workers' Medical Clinics since 2008, suffered from PMS.
According to literature review, high proportion of clinical trials regarding perimenopausal women used fixed formula treatment. However, different constitutional types were found in perimenopausal women and different fixed formulae were used in different research. Apart from kidney yin deficiency, perimenopausal women were also found in liver-kidney yin deficiency, kidney yang deficiency, kidney yin and yang deficiency, disharmony between heart and kidney, liver qi stagnation, etc. It is difficult to draw a conclusion that any single fixed formula could have the best efficacy on PMS. Therefore, it is worth studying to see whether syndrome differentiation would be a better choice for PMS treatment.
Read more
Objective: The study aims to evaluate whether syndrome differentiated treatment is better than fixed formula (Er-Xian decoction) treatment for perimenopausal women.
Design: This is a pilot single-blinded, randomized controlled trial.
Participants: Chinese women aged 45-55 year with menstruation abnormalities (menstrual irregularity in past 12 months; or menstrual period off at least twice in past 12 months; or amenorrhea of 2 to 12 months); also suffering any following perimenopausal symptoms: vasomotor symptoms (hot flushes, sweats), psychological symptoms (insomnia, migraine, irritability), or genitourinary symptoms (vaginal dryness, dyspareunia)
Interventions: A randomized controlled trial will be conducted to assess the efficacy of syndrome differentiated treatment versus a fixed formula (Er-Xian decoction) in treating PMS. 100 participants will be randomly divided into 2 groups. Intervention group of participants will be given medication by syndrome differentiating from qualified TCM Practitioners while the control group of participants will be given a fixed formula.
Outcome measures: Primary assessments outcome measure is the Kupperman Index, and the secondary outcome measure is MENQOL questionnaire.
Read the detailed description
Perimenopausal syndrome is also known as menopausal syndrome. Menopause Syndrome refers to women due to ovarian dysfunction or loss of estrogen causing a variety of systemic dysfunctions in the body, including the autonomic nervous system, dysfunction and metabolic disorders-based symptoms such as hot flushes and sweating, sleep disorders, depression, multiple joint pains, headache, dizziness, fatigue, etc. These symptoms seriously affect menopausal women . Modern medical treatment of perimenopausal syndrome mainly focus on Hormonal Therapy (HT). Studies have shown that the clinical effect of hormonal therapy would quickly relieve the symptoms of perimenopausal syndrome, including urogenital atrophy and prevention of osteoporosis .
However there were some scholars believed that although short-term use of hormone supplement therapy could relieve the symptoms of perimenopausal women, the role of estrogen treatment in postmenopausal women still needed to be further explored . The reason was that hormonal replacement therapy can cause more adverse reactions and potential risks such as increased cardiovascular disease, cerebral infarction, breast-related diseases, risk of embolism in veins and lungs and other diseases .
In the previous study, the investigators found that the Chinese herbal formula Er-Xian decoction was superior to placebo in reducing the frequency and severity of hot flushes and in relieving menopausal symptoms in Hong Kong perimenopausal women. It was well tolerated, with no serious adverse events noted during the study period. The study proved the effectiveness of traditional Chinese medicine in the treatment of menopausal symptoms. The investigators designed this experiment in order to further understand the effectiveness between syndrome differentiation treatment and fixed prescription.
Syndrome differentiation and treatment is the process of recognizing and resolving diseases, the embodiment of the combination of theory and practice, the specific clinical application of principles and methods, and the basic principles guiding the clinical work of traditional Chinese medicine. Dialectics is the process of authentication. Syndrome is a summary of the pathological reflections of the body through four diagnostic methods (inspection, listening and smelling, inquiries, and palpation ). It would help to establish disease stages, including the location of disease, cause, nature, and relationship between healthy qi and pathogenic qi. Therefore, the syndrome would reveal the essence of the disease, and therefore enhance the disease management. Corresponding treatment method is determined based on the result of syndrome differentiation. Syndrome differentiation and treatment are two inseparable parts in the process of diagnosis and treatment of diseases.
There is no record of the term of the perimenopausal syndrome in the ancient Chinese medicine books. The investigators can find some similar symptoms recorded in "Lily Disease" , "Hysteria", and "Insomnia"or "Depression" and other diseases in ancient books. Modern Chinese medicine gynecology calls it "Premenopausal". Traditional Chinese medicine believes that in perimenopausal women, the kidney qi is gradually declining. Dysfunction of qi and blood is mainly caused by kidney deficiency. Among them, the syndrome of kidney yin deficiency is the most common. According to the literature, the syndrome types are divided as follows:
- Liver and Kidney Yin Deficiency Syndrome: Before and after menstruation, the essence and blood are weak, or the body is in yin deficiency, yin does not guard the yang, yang is disturbed. Clinical symptoms include sweating, hot flushes, insomnia, forgetfulness, backache and weak legs, dry genitals, menstrual disorders, red tongue with less coating, pulse is rapid and thready. Suggested Formula: Gan Mai Bai He Di Hung Tang
- Non Interaction Between Heart and Kidney:The woman's yin and yang are imbalanced, the yin essence is deficient, and the kidney yin deficiency and water does not nourish the wood, causing the liver fire to become prosperous. Common clinical symptoms include hot flush, sweating, palpitation, irritability, bitter mouth, dry mouth, red tongue with thin yellow coating, pulse is thready and rapid. Suggested formula: Tian Wang Bu Xin Dan
- Liver stagnation and qi stagnation syndrome: Chest tightness, hypotension, chest pain, mental depression, nervousness, abdominal pain, flushing, nervousness, petechial, chord pulse. Suggested formula: Shugan Granules (Danzhi Xiaoyao San without Ginger add Xiangfu)
- Kidney Yin Deficiency Syndrome: Fever, sweating, upset, Insomnia, dry mouth, ant feeling on the skin, early menstruation. Suggested formula: Liu Wei Di Huang Pill and Er Zhi Pill
- Spleen and Kidney Yang Deficiency Syndrome:Fatigue, delayed menstruation, swelling, fear of cold, frequent urination, pale tongue, white fur, deep and thread pulse. Suggested formula: You Gui pill and Li Zhong pill addition and subtraction
- Conditions
- Menopausal Syndrome
- Being tested
- Intervention Group, Control Group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Also called Chinese herbal medicine
Gan Mai Bai He Di Hung Tang, Tian Wang Bu Xin Dan,Shugan Granules,Liu Wei Di Huang Pill and Er Zhi Pill , You Gui pill and Li Zhong pill addition and subtraction
Control GroupDrug
Also called Chinese herbal medicine
Er-Xian decoction
| Study group | Role | What they receive |
|---|---|---|
| Syndrome differentiation treatment(GMBHDHT, TWBXD,SG,LWDHP and EZP, YGP and LZP) | Experimental | Syndrome differentiation treatment group of participants will be given medication by syndrome differentiating from qualified TCM Practitioners. TCM Practitioners will base on the syndrome of the participants to evaluate and modify the prescription after each assessment.
1. Liver and Kidney Yin Deficiency syndrome use Gan Mai Bai He Di Hung Tang(GMBHDHT);
2. Non Interaction Between Heart and Kidney syndrome use Tian Wang Bu Xin Dan(TWBXD);
3. Liver Stagnation and Qi Stagnation syndrome use Shugan Granules(SG);
4. Kidney Yin Deficiency syndrome use Liu Wei Di Huang Pill and Er Zhi Pill(LWDHP and EZP) ;
5. Spleen and Kidney Yang Deficiency syndrome use You Gui pill and Li Zhong pill addition and subtraction(YGP and LZP).
Each dose will be prepackaged in two identical foil sachets. Participants will be instructed to drink one sachet of granules dissolved in 200 mL of warm water twice daily. Receives: Drug: Intervention Group |
| Fixed formula treatment | Experimental | Fixed formula treatment Group will be given the standard formula Er-Xian decoction consisting of six herbs. The dosages of each herb were standardized according to the latest Chinese Medicine Recipe Dictionary (1997). The standard formula Er-Xian decoction are in the form of water-soluble granules. Each dose contains 11.8g and prepackaged in two identical foil sachets. Participants were instructed to drink one sachet of granules dissolved in 200 mL of warm water twice daily. Receives: Drug: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kupperman Index
The evaluation is based on the clinical research experience of Kupperman HS in 1950s, which is composed of patient self-report and physician rating. The questionnaire includes 11 climacteric symptoms. The degree of symptoms was divide into four grades ranged from 0 to III: 0 for asymptomatic, I for occasional symptoms, II for frequent symptoms, and III for serious impact of life. These ratings were then summed across the 11 items and the score was categorized as follows: none 0-5, mild 5-10, moderate 10-15, severe 15+.
Measured: 8 weeks
Secondary outcomes (1)
Menopause Specific Quality of Life
Menopause Specific Quality of Life (MENQOL) was developed by Canadian scholars in 1996 as a tool to assess the quality of life of climacteric women. MENQOL is a self-management questionnaire. From the initial 106 items to 29 items, Each item assesses the impact of one of four domains of menopausal symptoms, as experienced over the last month: vasomotor, psychosocial, physical, and sexual. Items pertaining to a specific symptom are rated as present or not present, and if present, how bothersome on a zero (not bothersome) to six (extremely bothersome) scale. Means are computed for each subscale by dividing the sum of the domain's items by the number of items within that domain. For each item, participants are asked whether they have experienced each symptom in the past month and scored accordingly. The lower the score presents the higher the quality of life and the higher the score means the worse the quality of life.
Measured: 0,2,4,6,8,10,16 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2022
- Study start14 Mar 2022
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hong Kong Baptist University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhong Lidan, Hong Kong Baptist University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05266079
- Sponsor's protocol ID
- CSPSCHM
- Status last verified
- Sep 2023
- First submitted
- 14 Feb 2022
- Last updated
- 29 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Study of the Effectiveness Between Syndrome Differentiation Treatments and Fixed Formula Treatment for Perimenopausal Syndrome With Chinese Herbal Medicine
- ClinicalTrials.gov ID
- NCT05266079
- Acronym / sponsor ID
- CSPSCHM
- Conditions
- Menopausal Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Hong Kong Baptist UniversityUniversity, hospital or other
- Study start
- 14 Mar 2022 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 4 Mar 2022 (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.
Background: Perimenopausal syndrome (PMS) refers to a series of symptoms caused by the dynamic fluctuations of sex hormones during menopause. Menopausal symptoms including hot flushes, vaginal dryness and mood swings are experienced by about 80% of Chinese women aged 45 to 60. In the past year, 235 patients visited CMCTR(ND), a TCM center set up by HA and operated by HKFTU Workers' Medical Clinics since 2008, suffered from PMS.
According to literature review, high proportion of clinical trials regarding perimenopausal women used fixed formula treatment. However, different constitutional types were found in perimenopausal women and different fixed formulae were used in different research. Apart from kidney yin deficiency, perimenopausal women were also found in liver-kidney yin deficiency, kidney yang deficiency, kidney yin and yang deficiency, disharmony between heart and kidney, liver qi stagnation, etc. It is difficult to draw a conclusion that any single fixed formula could have the best efficacy on PMS. Therefore, it is worth studying to see whether syndrome differentiation would be a better choice for PMS treatment.
Objective: The study aims to evaluate whether syndrome differentiated treatment is better than fixed formula (Er-Xian decoction) treatment for perimenopausal women.
Design: This is a pilot single-blinded, randomized controlled trial.
Participants: Chinese women aged 45-55 year with menstruation abnormalities (menstrual irregularity in past 12 months; or menstrual period off at least twice in past 12 months; or amenorrhea of 2 to 12 months); also suffering any following perimenopausal symptoms: vasomotor symptoms (hot flushes, sweats), psychological symptoms (insomnia, migraine, irritability), or genitourinary symptoms (vaginal dryness, dyspareunia)
Interventions: A randomized controlled trial will be conducted to assess the efficacy of syndrome differentiated treatment versus a fixed formula (Er-Xian decoction) in treating PMS. 100 participants will be randomly divided into 2 groups. Intervention group of participants will be given medication by syndrome differentiating from qualified TCM Practitioners while the control group of participants will be given a fixed formula.
Outcome measures: Primary assessments outcome measure is the Kupperman Index, and the secondary outcome measure is MENQOL questionnaire.
Detailed description
Perimenopausal syndrome is also known as menopausal syndrome. Menopause Syndrome refers to women due to ovarian dysfunction or loss of estrogen causing a variety of systemic dysfunctions in the body, including the autonomic nervous system, dysfunction and metabolic disorders-based symptoms such as hot flushes and sweating, sleep disorders, depression, multiple joint pains, headache, dizziness, fatigue, etc. These symptoms seriously affect menopausal women . Modern medical treatment of perimenopausal syndrome mainly focus on Hormonal Therapy (HT). Studies have shown that the clinical effect of hormonal therapy would quickly relieve the symptoms of perimenopausal syndrome, including urogenital atrophy and prevention of osteoporosis .
However there were some scholars believed that although short-term use of hormone supplement therapy could relieve the symptoms of perimenopausal women, the role of estrogen treatment in postmenopausal women still needed to be further explored . The reason was that hormonal replacement therapy can cause more adverse reactions and potential risks such as increased cardiovascular disease, cerebral infarction, breast-related diseases, risk of embolism in veins and lungs and other diseases .
In the previous study, the investigators found that the Chinese herbal formula Er-Xian decoction was superior to placebo in reducing the frequency and severity of hot flushes and in relieving menopausal symptoms in Hong Kong perimenopausal women. It was well tolerated, with no serious adverse events noted during the study period. The study proved the effectiveness of traditional Chinese medicine in the treatment of menopausal symptoms. The investigators designed this experiment in order to further understand the effectiveness between syndrome differentiation treatment and fixed prescription.
Syndrome differentiation and treatment is the process of recognizing and resolving diseases, the embodiment of the combination of theory and practice, the specific clinical application of principles and methods, and the basic principles guiding the clinical work of traditional Chinese medicine. Dialectics is the process of authentication. Syndrome is a summary of the pathological reflections of the body through four diagnostic methods (inspection, listening and smelling, inquiries, and palpation ). It would help to establish disease stages, including the location of disease, cause, nature, and relationship between healthy qi and pathogenic qi. Therefore, the syndrome would reveal the essence of the disease, and therefore enhance the disease management. Corresponding treatment method is determined based on the result of syndrome differentiation. Syndrome differentiation and treatment are two inseparable parts in the process of diagnosis and treatment of diseases.
There is no record of the term of the perimenopausal syndrome in the ancient Chinese medicine books. The investigators can find some similar symptoms recorded in "Lily Disease" , "Hysteria", and "Insomnia"or "Depression" and other diseases in ancient books. Modern Chinese medicine gynecology calls it "Premenopausal". Traditional Chinese medicine believes that in perimenopausal women, the kidney qi is gradually declining. Dysfunction of qi and blood is mainly caused by kidney deficiency. Among them, the syndrome of kidney yin deficiency is the most common. According to the literature, the syndrome types are divided as follows:
- Liver and Kidney Yin Deficiency Syndrome: Before and after menstruation, the essence and blood are weak, or the body is in yin deficiency, yin does not guard the yang, yang is disturbed. Clinical symptoms include sweating, hot flushes, insomnia, forgetfulness, backache and weak legs, dry genitals, menstrual disorders, red tongue with less coating, pulse is rapid and thready. Suggested Formula: Gan Mai Bai He Di Hung Tang
- Non Interaction Between Heart and Kidney:The woman's yin and yang are imbalanced, the yin essence is deficient, and the kidney yin deficiency and water does not nourish the wood, causing the liver fire to become prosperous. Common clinical symptoms include hot flush, sweating, palpitation, irritability, bitter mouth, dry mouth, red tongue with thin yellow coating, pulse is thready and rapid. Suggested formula: Tian Wang Bu Xin Dan
- Liver stagnation and qi stagnation syndrome: Chest tightness, hypotension, chest pain, mental depression, nervousness, abdominal pain, flushing, nervousness, petechial, chord pulse. Suggested formula: Shugan Granules (Danzhi Xiaoyao San without Ginger add Xiangfu)
- Kidney Yin Deficiency Syndrome: Fever, sweating, upset, Insomnia, dry mouth, ant feeling on the skin, early menstruation. Suggested formula: Liu Wei Di Huang Pill and Er Zhi Pill
- Spleen and Kidney Yang Deficiency Syndrome:Fatigue, delayed menstruation, swelling, fear of cold, frequent urination, pale tongue, white fur, deep and thread pulse. Suggested formula: You Gui pill and Li Zhong pill addition and subtraction
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Syndrome differentiation treatment(GMBHDHT, TWBXD,SG,LWDHP and EZP, YGP and LZP) | Experimental | Drug: Intervention GroupSyndrome differentiation treatment group of participants will be given medication by syndrome differentiating from qualified TCM Practitioners. TCM Practitioners will base on the syndrome of the participants to evaluate and modify the prescription after each assessment. 1. Liver and Kidney Yin Deficiency syndrome use Gan Mai Bai He Di Hung Tang(GMBHDHT); 2. Non Interaction Between Heart and Kidney syndrome use Tian Wang Bu Xin Dan(TWBXD); 3. Liver Stagnation and Qi Stagnation syndrome use Shugan Granules(SG); 4. Kidney Yin Deficiency syndrome use Liu Wei Di Huang Pill and Er Zhi Pill(LWDHP and EZP) ; 5. Spleen and Kidney Yang Deficiency syndrome use You Gui pill and Li Zhong pill addition and subtraction(YGP and LZP). Each dose will be prepackaged in two identical foil sachets. Participants will be instructed to drink one sachet of granules dissolved in 200 mL of warm water twice daily. |
| Fixed formula treatment | Experimental | Drug: Control GroupFixed formula treatment Group will be given the standard formula Er-Xian decoction consisting of six herbs. The dosages of each herb were standardized according to the latest Chinese Medicine Recipe Dictionary (1997). The standard formula Er-Xian decoction are in the form of water-soluble granules. Each dose contains 11.8g and prepackaged in two identical foil sachets. Participants were instructed to drink one sachet of granules dissolved in 200 mL of warm water twice daily. |
Who may qualify
- Ages
- 45 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Chinese women aged 45-55 years
- Menstruation abnormalities (menstrual irregularity in past 12 months; or menstrual period off at least twice in past 12 months; or amenorrhea of 2 to 12 months)
- Suffering any of the following perimenopausal symptoms: vasomotor symptoms (hot flushes, sweats), psychological symptoms (insomnia, migraine, irritability), or genitourinary symptoms (vaginal dryness, dyspareunia)
- Did not use hormonal therapy at least 3 months before entry into the study
- Willing to give a written informed consent form to participate in the clinical study
Key exclusion criteria (10 listed)
- Bilateral ovarian resection or pelvic radiotherapy for ovarian cysts and uterine fibroids with a diameter greater than 4 cm
- Unexplained irregular vaginal bleeding
- Suffer from diabetic neuropathy or malignant tumor
- Have used sex hormones in the past 3 months, such as estrogen, progesterone, soy isoflavones etc.
- Patients who have participated in or are participating in other clinical trials in the past 3 months
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 |
|---|---|---|
| Intervention GroupAlso: Chinese herbal medicineGan Mai Bai He Di Hung Tang, Tian Wang Bu Xin Dan,Shugan Granules,Liu Wei Di Huang Pill and Er Zhi Pill , You Gui pill and Li Zhong pill addition and subtraction | Drug | Syndrome differentiation treatment(GMBHDHT, TWBXD,SG,LWDHP and EZP, YGP and LZP) |
| Control GroupAlso: Chinese herbal medicineEr-Xian decoction | Drug | Fixed formula treatment |
Primary outcome
Kupperman Index
Time frame: 8 weeks
The evaluation is based on the clinical research experience of Kupperman HS in 1950s, which is composed of patient self-report and physician rating. The questionnaire includes 11 climacteric symptoms. The degree of symptoms was divide into four grades ranged from 0 to III: 0 for asymptomatic, I for occasional symptoms, II for frequent symptoms, and III for serious impact of life. These ratings were then summed across the 11 items and the score was categorized as follows: none 0-5, mild 5-10, moderate 10-15, severe 15+.
1 secondary outcome
Menopause Specific Quality of Life
Time frame: 0,2,4,6,8,10,16 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2023.
- Individual participant dataSharing planned: No
Related trials for Menopausal Syndrome
Enrolling by invitation
Transcutaneous Auricular Neurostimulation (tAN) for Premenstrual Dysphoric Disorder (PMDD) and Perimenopause
Perimenopause, PMDD
Recruiting
Serum Endogenous Estrogens, Estrogen Receptors, and Sirtuin-1 and -3 After Resveratrol Supplementation
Coronary Artery Disease (CAD), Menopause
Recruiting
Effects of a Dietary Intervention Based on the Dietary Guidelines for the Brazilian Population on the Reduction of Menopausal Symptoms in Overweight and Obese Women
Menopause, Menopause Hot Flashes
Recruiting
Exercise as Medicine: A Non-Pharmacological Approach to Menopausal Symptoms
Menopause Syndrome, Sleep Disturbance
Active, not recruiting
Reexamining Her Cardiovascular Risk - Ottawa WomeN's Longitudinal Cohort Study
Cardiovascular Diseases
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention Group in people with Menopausal Syndrome, run by Hong Kong Baptist University 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 5 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: finished, as of the sponsor's last update on 29 Sep 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kupperman Index (time frame: 8 weeks). 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 29 Sep 2023.