Hot flushes are the most frequent climacteric symptom and 10-20% of all women after menopause have nearly intolerable hot flushes. Homnis placenta extract pharmacopuncture is one of the new acupuncture therapies popular in East Asian medicine and known to be effective in facial flushing. However, there is a lack of research on effectiveness and safety of Homnis placenta extract pharmacopuncture. We aim to evaluate the efficacy and safety of Homnis placenta extract (Which is named PLC) pharmacopuncture, compared to NS injection, on hot flushes in perimenopausal and postmenopausal women in Korea.
This study is a randomized placebo controlled, single-blind, multi-center, parallel designed trial. 128 perimenopausal or postmenopausal women who meet the inclusion criteria will be recruited.The treatment group will receive PLC pharmacoacupuncture 2 times a week, for a total of 18 sessions over 9 weeks. The control group will receive NS acupoint injection during the same period. Post-treatment follow-up assessment will be performed 4 week after completing the treatment.
This trial will provide evidence for the efficacy and safety of PLC pharmacoacupuncture as a treatment for hot flushes in perimenopausal and postmenopausal women.

Treatment

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 up to 8mm and 0.5cc of PLC will be injected. Control group will receive Normal Saline injection at the same point using same technique. After the procedure, participants will receive an infrared irradiation for 20 minutes to feel warm in the lower abdomen at a distance of 30 to 60cm. No other treatment than the prescribed treatment shall be carried out during the test period. 
The drug for this clinical trial, code named PLC, is the extract of Hominis placenta and will be manufactured by Unimed pharmaceutical company (Seoul, Republic of Korea). Hominis placenta will be isolated from healthy pregnant women after delivery and it go through sterilization and hydrolysis extraction procedures. The PLC is manufactured in accordance with Korean good manufacturing practice. Normal saline for control group consisits of sodium chloride 180mg/20ml (0.9%). Researchers will purchase the Normal Saline manufactured by Daihan Pharm Co. (Seoul, Republic of Korea). Researcher will labelling both PLC and NS.

Arm Label

Target Number of Participant

Arm Type

Arm Description

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 up to 8mm and 0.5cc of PLC will be injected.

Arm Label

Target Number of Participant

Arm Type

Arm Description

Control group will receive Normal saline 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 up to 8mm and 0.5cc of Normal saline will be injected.

Gender

Age

Description

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)
① 	Have a history of amenorrhea for last 3~11 months from the consent day (visit 1)
②  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)
① 	Have a history of spontaneous amenorrhea for last 12 months
② 	6 months of spontaneous amenorrhea with serum follicle-stimulating hormone levels greater than 40mIU/mL
③  At least 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy	
④  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

Hot flash score

every week

Menopausal Rating Scale

every 1 month

follicle stimulating hormone, estradiol

visit 1, visit 18