Hot FlashesNCT05922800
Effectiveness of Electro-Press Needle and Gamma-Oryzanol for Menopause-associated Hot Flashes
A study testing Electro Press Needle and Gamma-Oryzanol in people with Hot Flashes and Acupuncture Therapy, run by Dongzhimen Hospital, Beijing.
Trial summary
The investigators plan to conduct the randomized controlled trial to evaluate the effectiveness of electro-press needle (EPN), a novel acupuncture needle combining shallow and gentle insertion with transdermal electrical stimulation, on menopause-associated hot flash in comparison with gamma-oryzanol group among women… Read more about this study
- Who is it for?
- Ages 40 to 60 years, women only
- Conditions the study is for
- Hot Flashes, Acupuncture Therapy, Perimenopausal Disorder
- What is being tested?
- Electro Press Needle and Gamma-Oryzanol
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- 19 Jun 2023to 30 Jun 2024
- 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 40 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Aged between 40-60 years old;
- Scoring 14 points or more in at least one day during the one-week baseline assessment, or having an average of ≥ 7 moderate or severe heating per 24 hours recorded in HF Dairy ;
- Fulfilling either condition mentioned below:
- The last menstrual period was more than 12 months ago (including 12 months);
- In the late menopausal transition, and has amenorrhea for more than 60 days;
- FSH≥25IU, and has vasomotor symptoms of HF, sweating, insomnia, migraine, or restlessness, etc.
- Volunteer to participate in this study and sign the informed consent.
Who cannot join
- Usage of HRT via transdermal administration in the previous one month, or via oral or intrauterine administration in the previous two months; usage of phytoestrogens therapy, transvaginal estrogen administration, or estrogen or progesterone injections in the previous three months;
- Bilateral salpingo-oophorectomy;
- Amenorrhea secondary to premature ovarian failure, ovarian cyst or tumor, thyroid disease, hyperprolactinemia, or Cushing's syndrome, etc.;
- Accepted acupuncture or drugs to treat the symptoms of HF within the previous 3 months;
- Received radiotherapy or chemotherapy before;
- Coagulation dysfunction, or taking warfarin, heparin and other anticoagulant drugs at present;
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- Suffering from skin diseases, such as eczema, psoriasis, etc.;
- Severe hepatic and renal insufficiency;
- Uncontrolled hypertension, diabetes or thyroid disease;
- Diabetic neuropathy and mental illness (including depression);
- Being pregnant, breastfeeding or planning to be pregnant during the trial;
- Regular usage of sedatives or anti-anxiety drugs;
- Smoking for more than 5 years (at least twenty cigarettes a day on average) , or with the problem of alcohol abuse;
- Installation of pacemakers;
- Poor compliance.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effectiveness and Safety of Electro-press Needle and Gamma-oryzanol for Menopause-associated Hot Flashes: Protocol of a Randomized Controlled Trial
The investigators plan to conduct the randomized controlled trial to evaluate the effectiveness of electro-press needle (EPN), a novel acupuncture needle combining shallow and gentle insertion with transdermal electrical stimulation, on menopause-associated hot flash in comparison with gamma-oryzanol group among women during menopausal transition and postmenopausal periods.
Read the detailed description
As the most common type of menopause-associated symptoms, hot flashes affect up to 85% of women aging between 40 and 65 years . In China, women suffer from hot flushes as long as 4 to 5 years on average, some of whom may bear the symptoms for 12 years.Hormone replacement therapy (HRT) is generally recommended to relieve menopause-associated hot flashes.However, long-term usage of HRT may increase the incidence of endometrial, breast and ovarian cancer, thrombosis and strokes.Results of previous studies indicated that acupuncture might help to relieve the symptoms.There is insufficient evidence supporting its effectiveness for relieving the hot flash symptom.
- Being tested
- Electro Press Needle, Gamma-Oryzanol
- Keywords
- gamma-oryzanol, Electro-Press Needle
- Medical subject headings
- Hot Flashes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electro Press NeedleDevice
Also called Electro Thumb Needle
Body acupoints will be stimulated by the press needles 0.25mm in diameter and 2mm in length and ear acupoints will be stimulated by the press needles 0.25mm in diameter and 0.9mm in length (all from ZhenXing Brand, Hangzhou Yuanli Medical Appliance Factory, China). After sterilization of the local skin, the needle will be pressed to the acupoints and the tape will be sticked to the skin. Then, the electric device (φ44×15.8mm Type ZXHPAMDZB-02C) together with the electrode patch will be sticked to the surface of skin (on top of the sticky tapes of the press needle) in the area of CV4 and bilateral EX-CA1, and bilateral SP6 respectively. The electric device will be switch to the mode of "dense intermittent wave", and the current intensity will be increased gradually till the muscles around jumps slightly.All the needles on the body acupoints will be removed after each session, while those on the auricular acupoints can be kept for as long as 6 hours (removed before going to bed).
Gamma-OryzanolDrug
The patients in this group were given orally gamma-oryzanol tablets 20mg each time, three times a day, for 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Electro Press Needle | Experimental | Body acupoints of Yintang (GV29), Dazhui (GV14), Guanyuan (CV4), bilateral Zigong (EX-CA1), and bilateral Sanyinjiao (SP6) and auricular acupoints of Heart (CO15), Chuiqian (LO4) and Shenmen (TF4) will be selected for treatment. Auricular acupoints on right and left ear will be stimulated alternatively, one side on each time.The treatment will last 40mins for each session, 3 sessions a week (ideally every other day) for a succession of 6 weeks. Receives: Device: Electro Press Needle |
| Gamma-Oryzanol | Active comparator | The patients in this group were given 10mgx100 tablets/bottle of gamma-oryzanol tablets (Tianjin Lishen Pharmaceutical), 20mg each time, three times a day, for 6 months. Receives: Drug: Gamma-Oryzanol |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients with a reduction of 50% or more on the mean 24-hour HF score from baseline
The mean 24-hour HF score = (1 × number of mild HF + 2 × number of moderate HF + 3 × number of severe HF + 4 × number of very severe HF)/Number of days reported.
Measured: week 6
Secondary outcomes (9)
The proportion of participants with a reduction of 50% or more on the mean 24-hour HF score from baseline
The mean 24-hour HF score = (1 × number of mild HF + 2 × number of moderate HF + 3 × number of severe HF + 4 × number of very severe HF)/Number of days reported.
Measured: week 3,18,30
The proportion of participants with a reduction of 50% or more in the mean 24-hour HF frequency from baseline24-hour HF score from baseline
The mean 24-hour HF frequency = total number of HF reported/Number of days reported.
Measured: week 3,6,18,30
The proportion of patients with at least a 50% reduction in the mean 24-hour HF severity from baselineHF frequency from baseline24-hour HF score from baseline
The mean 24-hour HF severity = (1 × number of mild HF + 2 × number of moderate HF + 3 × number of severe HF + 4 × number of very severe HF)/ Number of HF reported.
Measured: week 3,6,18,30
The changes in the mean 24-h HF score from baseline
The mean 24-hour HF score = (1 × number of mild HF + 2 × number of moderate HF + 3 × number of severe HF + 4 × number of very severe HF)/Number of days reported.
Measured: week 3,6,18,30
The change of Menopause rating scale (MRS) score from baseline
MRS is a common menopause specific subscale, including 11 items from psychological, somatic to urogenital, with 5 as minimal clinically important differences(MCID).
Measured: week 6,18 and 30
The change of Menopause-Specific Quality of Life Questionnaire (MENQOL) score from baseline
MENQOL consists of 29 items assessing four domains: VMS, physical symptoms, psychological symptoms, and urogenital/sexual symptoms,with 4 as minimal clinically important differences(MCID).
Measured: week 6,18 and 30
Time domain analysis of 24-hour heart rate variability(HRV)
The indexes included total autonomic energy (SDNN) and sympathetic sensation Nerve tone (SDANN) and vagal tone (rMSSD)
Measured: week 6,30
Frequency domain analysis of 24-hour heart rate variability(HRV)
the indexes included total power spectrum (TP) reflecting the total energy of autonomic nerve, The low frequency power (LF, 0.04~0.15Hz) reflects the sympathetic nerve activity and the high vagus nerve activity.Frequency power (HF, 0.15~0.4Hz), LF/HF reflecting the balance between sympathetic and vagal tension.
Measured: week 6,30
The proportion of participants reporting "significantly reduced" or "moderately reduced" based on Global Response Assessment (GRA)
The response of participants to the treatments are divided into seven grades by GRA: significantly reduced, moderately reduced, slightly reduced, no change, slightly aggravated, moderately aggravated and significantly aggravated. The proportion of participants reporting "significantly reduced" or "moderately reduced" are recorded as the response rate of the overall efficacy.
Measured: week 3,6,18,30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2023
- Study start19 Jun 2023 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hot FlashesStudies 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dongzhimen Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu Shudan, Dongzhimen Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05922800
- Sponsor's protocol ID
- 2023DZMEC-155-02
- Status last verified
- Jun 2023
- First submitted
- 7 Jun 2023
- Last updated
- 28 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of Electro-press Needle and Gamma-oryzanol for Menopause-associated Hot Flashes: Protocol of a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05922800
- Acronym / sponsor ID
- 2023DZMEC-155-02
- Keywords
- gamma-oryzanol, Electro-Press Needle
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Dongzhimen Hospital, BeijingUniversity, hospital or other
- Study start
- 19 Jun 2023 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 28 Jun 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.
The investigators plan to conduct the randomized controlled trial to evaluate the effectiveness of electro-press needle (EPN), a novel acupuncture needle combining shallow and gentle insertion with transdermal electrical stimulation, on menopause-associated hot flash in comparison with gamma-oryzanol group among women during menopausal transition and postmenopausal periods.
Detailed description
As the most common type of menopause-associated symptoms, hot flashes affect up to 85% of women aging between 40 and 65 years . In China, women suffer from hot flushes as long as 4 to 5 years on average, some of whom may bear the symptoms for 12 years.Hormone replacement therapy (HRT) is generally recommended to relieve menopause-associated hot flashes.However, long-term usage of HRT may increase the incidence of endometrial, breast and ovarian cancer, thrombosis and strokes.Results of previous studies indicated that acupuncture might help to relieve the symptoms.There is insufficient evidence supporting its effectiveness for relieving the hot flash symptom.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electro Press Needle | Experimental | Device: Electro Press NeedleBody acupoints of Yintang (GV29), Dazhui (GV14), Guanyuan (CV4), bilateral Zigong (EX-CA1), and bilateral Sanyinjiao (SP6) and auricular acupoints of Heart (CO15), Chuiqian (LO4) and Shenmen (TF4) will be selected for treatment. Auricular acupoints on right and left ear will be stimulated alternatively, one side on each time.The treatment will last 40mins for each session, 3 sessions a week (ideally every other day) for a succession of 6 weeks. |
| Gamma-Oryzanol | Active comparator | Drug: Gamma-OryzanolThe patients in this group were given 10mgx100 tablets/bottle of gamma-oryzanol tablets (Tianjin Lishen Pharmaceutical), 20mg each time, three times a day, for 6 months. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Aged between 40-60 years old;
- Scoring 14 points or more in at least one day during the one-week baseline assessment, or having an average of ≥ 7 moderate or severe heating per 24 hours recorded in HF Dairy ;
- Fulfilling either condition mentioned below:
- Volunteer to participate in this study and sign the informed consent.
Key exclusion criteria (15 listed)
- Usage of HRT via transdermal administration in the previous one month, or via oral or intrauterine administration in the previous two months; usage of phytoestrogens therapy, transvaginal estrogen administration, or estrogen or progesterone injections in the previous three months;
- Bilateral salpingo-oophorectomy;
- Amenorrhea secondary to premature ovarian failure, ovarian cyst or tumor, thyroid disease, hyperprolactinemia, or Cushing's syndrome, etc.;
- Accepted acupuncture or drugs to treat the symptoms of HF within the previous 3 months;
- Received radiotherapy or chemotherapy before;
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 |
|---|---|---|
| Electro Press NeedleAlso: Electro Thumb NeedleBody acupoints will be stimulated by the press needles 0.25mm in diameter and 2mm in length and ear acupoints will be stimulated by the press needles 0.25mm in diameter and 0.9mm in length (all from ZhenXing Brand, Hangzhou Yuanli Medical Appliance Factory, China). After sterilization of the local skin, the needle will be pressed to the acupoints and the tape will be sticked to the skin. Then, the electric device (φ44×15.8mm Type ZXHPAMDZB-02C) together with the electrode patch will be sticked to the surface of skin (on top of the sticky tapes of the press needle) in the area of CV4 and bilateral EX-CA1, and bilateral SP6 respectively. The electric device will be switch to the mode of "dense intermittent wave", and the current intensity will be increased gradually till the muscles around jumps slightly.All the needles on the body acupoints will be removed after each session, while those on the auricular acupoints can be kept for as long as 6 hours (removed before going to bed). | Device | Electro Press Needle |
| Gamma-OryzanolThe patients in this group were given orally gamma-oryzanol tablets 20mg each time, three times a day, for 6 months. | Drug | Gamma-Oryzanol |
Primary outcome
The proportion of patients with a reduction of 50% or more on the mean 24-hour HF score from baseline
Time frame: week 6
The mean 24-hour HF score = (1 × number of mild HF + 2 × number of moderate HF + 3 × number of severe HF + 4 × number of very severe HF)/Number of days reported.
9 secondary outcomes
The proportion of participants with a reduction of 50% or more on the mean 24-hour HF score from baseline
Time frame: week 3,18,30
The proportion of participants with a reduction of 50% or more in the mean 24-hour HF frequency from baseline24-hour HF score from baseline
Time frame: week 3,6,18,30
The proportion of patients with at least a 50% reduction in the mean 24-hour HF severity from baselineHF frequency from baseline24-hour HF score from baseline
Time frame: week 3,6,18,30
The changes in the mean 24-h HF score from baseline
Time frame: week 3,6,18,30
The change of Menopause rating scale (MRS) score from baseline
Time frame: week 6,18 and 30
The change of Menopause-Specific Quality of Life Questionnaire (MENQOL) score from baseline
Time frame: week 6,18 and 30
Time domain analysis of 24-hour heart rate variability(HRV)
Time frame: week 6,30
Frequency domain analysis of 24-hour heart rate variability(HRV)
Time frame: week 6,30
The proportion of participants reporting "significantly reduced" or "moderately reduced" based on Global Response Assessment (GRA)
Time frame: week 3,6,18,30
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2023.
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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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Electro Press Needle and Gamma-Oryzanol in people with Hot Flashes and Acupuncture Therapy, run by Dongzhimen Hospital, Beijing.
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 7 inclusion and 15 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 28 Jun 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shudan Yu, Doctor (15011460149, miaomiao101@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of patients with a reduction of 50% or more on the mean 24-hour HF score from baseline (time frame: week 6). 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 28 Jun 2023.