Effectiveness of Electro-Press Needle and Gamma-Oryzanol for Menopause-associated Hot Flashes

NCT05922800 | Unknown

• 1 other identifier: 2023DZMEC-155-02
• Study Type: interventional
• Target: 64
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hot Flashes; Acupuncture Therapy; Perimenopausal Disorder; Postmenopausal Symptoms

Keywords

gamma-oryzanol; Electro-Press Needle

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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

  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

  week 3,6,18,30

• The changes in the mean 24-h HF score from baseline

  week 3,6,18,30

• The change of Menopause rating scale (MRS) score from baseline

  week 6,18 and 30

Other Outcomes (4)

• Participants'acceptability towards EPN

  week 1 and 3,at the end of the first and ninth treatments

• Participants' belief that EPN might help

  Baseline assessmentweek 0

• Participants' expectations of improvement to menopausal associated hot flashes

  Baseline assessment week 0

Study Arms (2)

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.

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.

Drug: Gamma-Oryzanol

Interventions

Electro Press Needle DEVICE

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).

Also known as: Electro Thumb Needle

Electro Press Needle

Gamma-Oryzanol DRUG

The patients in this group were given orally gamma-oryzanol tablets 20mg each time, three times a day, for 6 months.

Gamma-Oryzanol

Eligibility Criteria

• Age: 40 Years - 60 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dongzhimen Hospital, Beijing: lead

MeSH Terms

Conditions

Hot Flashes

Interventions

gamma-oryzanol

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Shudan Yu, Doctor

CONTACT

15011460149; miaomiao101@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The statisticians and outcome assessors will be blinded to the allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: June 7, 2023
• First Posted: June 28, 2023
• Study Start: June 19, 2023
• Primary Completion: December 31, 2023
• Study Completion: June 30, 2024
• Last Updated: June 28, 2023

Record last verified: 2023-06