Back to resultsEffectiveness of Electro-Press Needle and Gamma-Oryzanol for Menopause-associated Hot Flashes
Primary Purpose
Hot Flashes, Acupuncture Therapy, Perimenopausal Disorder
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Electro Press Needle
Gamma-Oryzanol
Sponsored by
About this trial
This is an interventional treatment trial for Hot Flashes focused on measuring gamma-oryzanol, Electro-Press Needle
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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; 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Electro Press Needle
Gamma-Oryzanol
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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).
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).
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)
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.
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.
Full Information
NCT ID
NCT05922800
First Posted
June 7, 2023
Last Updated
June 19, 2023
Sponsor
Dongzhimen Hospital, Beijing
1. Study Identification
Unique Protocol Identification Number
NCT05922800
Brief Title
Effectiveness of Electro-Press Needle and Gamma-Oryzanol for Menopause-associated Hot Flashes
Official Title
Effectiveness and Safety of Electro-press Needle and Gamma-oryzanol for Menopause-associated Hot Flashes: Protocol of a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 19, 2023 (Anticipated)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dongzhimen Hospital, Beijing
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hot Flashes, Acupuncture Therapy, Perimenopausal Disorder, Postmenopausal Symptoms
Keywords
gamma-oryzanol, Electro-Press Needle
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Masking Description
The statisticians and outcome assessors will be blinded to the allocation.
Allocation
Randomized
Enrollment
64 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Electro Press Needle
Arm Type
Experimental
Arm Description
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.
Arm Title
Gamma-Oryzanol
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Electro Press Needle
Other Intervention Name(s)
Electro Thumb Needle
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Gamma-Oryzanol
Intervention Description
The patients in this group were given orally gamma-oryzanol tablets 20mg each time, three times a day, for 6 months.
Primary Outcome Measure Information:
Title
The proportion of patients with a reduction of 50% or more on the mean 24-hour HF score from baseline
Description
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.
Time Frame
week 6
Secondary Outcome Measure Information:
Title
The proportion of participants with a reduction of 50% or more on the mean 24-hour HF score from baseline
Description
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.
Time Frame
week 3,18,30
Title
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
Description
The mean 24-hour HF frequency = total number of HF reported/Number of days reported.
Time Frame
week 3,6,18,30
Title
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
Description
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.
Time Frame
week 3,6,18,30
Title
The changes in the mean 24-h HF score from baseline
Description
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.
Time Frame
week 3,6,18,30
Title
The change of Menopause rating scale (MRS) score from baseline
Description
MRS is a common menopause specific subscale, including 11 items from psychological, somatic to urogenital, with 5 as minimal clinically important differences(MCID).
Time Frame
week 6,18 and 30
Title
The change of Menopause-Specific Quality of Life Questionnaire (MENQOL) score from baseline
Description
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).
Time Frame
week 6,18 and 30
Title
Time domain analysis of 24-hour heart rate variability(HRV)
Description
The indexes included total autonomic energy (SDNN) and sympathetic sensation Nerve tone (SDANN) and vagal tone (rMSSD)
Time Frame
week 6,30
Title
Frequency domain analysis of 24-hour heart rate variability(HRV)
Description
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.
Time Frame
week 6,30
Title
The proportion of participants reporting "significantly reduced" or "moderately reduced" based on Global Response Assessment (GRA)
Description
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.
Time Frame
week 3,6,18,30
Other Pre-specified Outcome Measures:
Title
Participants'acceptability towards EPN
Description
Use the 3-point method to evaluate, unacceptable (0 points), acceptable (1 points), easy to accept (2 points), patients who cannot accept should be written the reason clearly.Only patients in electric press needle group will score.
Time Frame
week 1 and 3,at the end of the first and ninth treatments
Title
Participants' belief that EPN might help
Description
Participants in the EPN group will answer the following question before the first intervention: "Do you think acupuncture will be effective for treating the disease?"The participants can answer "Yes", "No", or "Unclear."
Time Frame
Baseline assessmentweek 0
Title
Participants' expectations of improvement to menopausal associated hot flashes
Description
Participants in the EPN group will answer the following question before the first intervention: "Do you think acupuncture will be effective for improving menopausal associated HF?" The participants can answer "Yes", "No", or "Unclear."
Time Frame
Baseline assessment week 0
Title
Safety assessment
Description
Adverse events and severe adverse events will be recorded in case report form, whether related to interventions or not.
Time Frame
Through study completion, an average of 30 weeks
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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;
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shudan Yu, Doctor
Phone
15011460149
Email
miaomiao101@126.com
12. IPD Sharing Statement
Learn more about this trial
Effectiveness of Electro-Press Needle and Gamma-Oryzanol for Menopause-associated Hot Flashes
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