None listed
Conditions
Interventions
Drug : Pharmacoacupuncture group will receive PLC injection on 4 acupoints, CV4, CV6, Ex-BB1 (Table 2), using 30 guage 1cc disposable syringe. At each acupoint, needle insertion will be to a depth of
). Researchers will purchase the Normal Saline manufactured by Daihan Pharm Co. (Seoul, Republic of Korea). Researcher will labelling both PLC and NS.
Sponsors
Dongguk University Ilsan Oriental Hospital
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 0. Women aged between 45 and 60 years of age 1. Peri-menopausal or post-menopausal women with hot flush 1) Peri-menopausal women (who meet one of the following criteria) ? Have a history of amenorrhea for last 3~11 months from the consent day (visit 1) ? Have suffered irregular menstrual periods in the past 12 months from the consent day (visit 1) 2) Post-menopausal women (who meet one of the following criteria) ? Have a history of spontaneous amenorrhea for last 12 months ? 6 months of spontaneous amenorrhea with serum follicle-stimulating hormone levels greater than 40mIU/mL ? At least 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy ? After Hysterectomy 2. Women who had average daily hot flash score of 10 or higher for 1 week before the visit1 (hot flash score : daily frequency X severity [normal: 0, mild: 1, moderate: 2, severe: 3, very severe: 4]). 3. Those who agree to this clinical study after sufficient explanation.
Exclusion criteria
Exclusion criteria: 0. Women who are diagnosed with psychogenic menopausal symptoms. 1. a patient suspected of systemic diseases. 2. Having severe complications on heart, liver, kidney or other organs. 3. A medical history of malignant tumors 4. Having thyroid disease or abnormal thyroid function 5. Having Liver or Kidney dysfunction : in case that any values of sGOT, sGPT, bilirubin or serum creatinine exceeding over 2 times of normal level 6. Difficult to participate in this trial because of these diseases : Uncontrolled hypertension, diabetes with complications or under control with insulin injections and pumps, thyroid disease and those who are taking drugs due to them, acute hepatitis/hepatocirrhosis, severe hyperlipidemia, neuropathic disorders, severe cardiovascular disorders, tuberculosis and other infectious diseases. 7. A person who has a history of hypersensitivity to Hominis Placenta or other drugs and food, or an allergic disease that requires treatment. 8. Taking hormones/ hormone analogues except estrogen or progestin within past 1 month. 9. Having participated in another clinical trial within the past 3 months. 10. Not taking the washout period (acupuncture and moxibustion : over 1week, herbal medication and pharmacoacupuncture :over 3 week) after receiving therapy that may affect perimenopausal or postmenopausal symptoms such as Korean medicine treatment or other complementary medicine 11. Participants who were taking estrogen or estrogen/progestin before (except who had adequate washout periods 12. Participants who were taking antidepressants in the last 1 month 13. Patients with illness who are determined unsuitable for the acupuncture treatment. 14. Person with inflammation or scar on the treatment area. 15. A night-shift worker. 16. Does not have the ability to fill out study documents. 17. a person who researcher determined unsuitable for this trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hot flash score | — |
Secondary
| Measure | Time frame |
|---|---|
| Menopausal Rating Scale;follicle stimulating hormone, estradiol | — |
Countries
Korea, Republic of
Contacts
Public ContactDong-Il Kim
Dongguk University Ilsan Oriental Hospital
Outcome results
None listed