None listed
Conditions
Interventions
Drug, Procedure/Surgery : Clinical Study Protocol
Study Design
This study will be conducted as a multicenter, randomized controlled trial (RCT).
Study Procedure
Screening: Participants who voluntaril
Sponsors
Dongguk University Ilsan Oriental Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria A participant must meet all of the following criteria to be eligible for the study: 1. Age: Women aged between 40 and 64 years (inclusive). 2. Menopausal Status: Perimenopausal or postmenopausal women experiencing hot flashes, defined as follows: o Perimenopausal Women (meeting one of the following): - Amenorrhea lasting for 3 to 11 months prior to the date of providing written informed consent (Visit 0), based on self-report. - Irregular menstrual cycles (changes in cycle length) within the 12 months prior to Visit 0. o Postmenopausal Women (meeting one of the following): - Spontaneous amenorrhea for at least the past 12 consecutive months. - Spontaneous amenorrhea for 6 months with a serum follicle-stimulating hormone (FSH) level of = 40mIU/mL. - At least 6 weeks post-bilateral oophorectomy (regardless of hysterectomy status). - History of hysterectomy. 3. Hot Flash Severity: A daily average Hot Flash Score = 10 during the week prior to Visit 0. The score is calculated by multiplying the daily frequency of hot flashes by their intensity (0: Normal, 1: Mild, 2: Moderate, 3: Severe, 4: Very Severe). 4. Daily Interference: An average score of = 4 on the Hot Flash Related Daily Interference Scale (HFRDIS). 5. Contraindications: No specific restrictions or contraindications for the administration of Gami-soyosan. 6. Informed Consent: Must have received a full explanation of the clinical study and voluntarily signed the informed consent form.
Exclusion criteria
Exclusion criteria: Exclusion Criteria Participants meeting any of the following criteria will be excluded from the study: 1. Hormone Therapy: Currently receiving female hormone therapy for menopausal symptoms. However, those who have completed the following washout periods may be included: o Vaginal hormonal preparations (rings, creams, gels, etc.): =1 week. o Transdermal preparations (Estrogen alone or Estrogen/Progestin): =4 weeks. o Oral Estrogen or Progestin: =8 weeks. o Intrauterine progestin therapy: =8 weeks. o Progestin implants or Estrogen injections: = 3 months. o Estrogen pellet therapy or Progestin injections: = 6 months. 2. Other Traditional/Alternative Treatments: Individuals who have received Korean medicine treatments (acupuncture, moxibustion, herbal medicine, pharmacopuncture) or other similar medical procedures that may affect menopausal symptoms, without completing the researcher-designated washout periods (e.g., = 1 week for acupuncture/moxibustion; = 3 weeks for herbal medicine/pharmacopuncture). 3. Autoimmune Diseases: Diagnosed with an autoimmune disease or tested positive for Antinuclear Antibody (ANA). 4. Thyroid Disorders: Diagnosed with hyperthyroidism or hypothyroidism, or currently taking thyroid-related medications with persisting symptoms. 5. Severe Organ Dysfunction: * Liver Insufficiency: AST or ALT = 100 IU/L o Renal Failure: Serum Creatinine = 2.0 mg/dL 6. Psychiatric Disorders: Suffering from behavioral disorders, depression, anxiety, or schizophrenia, or having severe mental disorders that hinder cooperation with outpatient follow-up and treatment. 7. Malignancy: History of or currently diagnosed with malignant tumors. 8. Organic Gynecological Diseases: Currently undergoing treatment for organic conditions such as endometrial cancer, ovarian cancer, or endometrial hyperplasia. 9. Recent Clinical Trial Participation: Participated in other clinical trials involving therapeutic interventions within the past 3 months. 10. Occupational Factors: Night-shift workers or those working overnight. 11. Researcher's Discretion: Any other individuals deemed unsuitable for participation in the clinical study by the principal investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hot Flash Related Daily Interference Scale | — |
Secondary
| Measure | Time frame |
|---|---|
| Hot flash score;The menopause specific quality of life questionnaire;Adverse Event;Vital sign;Blood test;Physical examination;Urine test | — |
Countries
Korea, Republic of
Contacts
Public ContactYounghyun Seol
Dongguk University Ilsan Oriental Hospital
Outcome results
None listed