Effectiveness and Safety of Electro-press Needle and Gamma-oryzanol for Menopause-associated Hot Flashes: Protocol of a Randomized Controlled Trial
Electro Press Needle
+ Gamma-Oryzanol
Signs and Symptoms
+ Pathological Conditions, Signs and Symptoms
+ Hot Flashes
Treatment Study
Summary
Study start date: June 19, 2023
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.64 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.From 40 to 60 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: 1. Aged between 40-60 years old; 2. 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 ; 3. Fulfilling either condition mentioned below: 1. The last menstrual period was more than 12 months ago (including 12 months); 2. In the late menopausal transition, and has amenorrhea for more than 60 days; 3. FSH≥25IU, and has vasomotor symptoms of HF, sweating, insomnia, migraine, or restlessness, etc. 4. Volunteer to participate in this study and sign the informed consent. Exclusion Criteria: 1. 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; 2. Bilateral salpingo-oophorectomy; 3. Amenorrhea secondary to premature ovarian failure, ovarian cyst or tumor, thyroid disease, hyperprolactinemia, or Cushing's syndrome, etc.; 4. Accepted acupuncture or drugs to treat the symptoms of HF within the previous 3 months; 5. Received radiotherapy or chemotherapy before; 6. Coagulation dysfunction, or taking warfarin, heparin and other anticoagulant drugs at present; 7. Suffering from skin diseases, such as eczema, psoriasis, etc.; 8. Severe hepatic and renal insufficiency; 9. Uncontrolled hypertension, diabetes or thyroid disease; 10. Diabetic neuropathy and mental illness (including depression); 11. Being pregnant, breastfeeding or planning to be pregnant during the trial; 12. Regular usage of sedatives or anti-anxiety drugs; 13. Smoking for more than 5 years (at least twenty cigarettes a day on average) , or with the problem of alcohol abuse; 14. Installation of pacemakers; 15. Poor compliance.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorStudy Objectives
Primary Objectives
Secondary Objectives