A randomized placebo controlled, single-blind, multicenter, parallel designed clinical study to evaluate the efficacy and safety of PLC in perimenopausal or postmenopausal women with Hot Flashes
- Conditions
- Endocrine, nutritional and metabolic disease
- Registration Number
- KCT0003533
- Lead Sponsor
- Dongguk University Ilsan Oriental Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 128
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.
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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Hot flash score
- Secondary Outcome Measures
Name Time Method Menopausal Rating Scale;follicle stimulating hormone, estradiol