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
Signos y Síntomas
+ Condiciones Patológicas, Signos y Síntomas
Estudio de Tratamiento
Resumen
Fecha de inicio: 19 de junio de 2023
Fecha en la que se inscribió al primer participante.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.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 64 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Tratamiento
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Mujer
Sexo biológico de los participantes elegibles para inscribirse.De 40 a 60 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
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.
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.2 grupos de intervención están designados en este estudio
0% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
ExperimentalGrupo II
Comparador ActivoObjetivos del Estudio
Objetivos Primarios
Objetivos Secundarios