Clinical and Basic Researches Related to ZhenQi Buxue Oral Liquid in Treating Menstrual Disorders
Phase: NA
Conditions: Menstrual Disorders
Sponsor: Peking Union Medical College Hospital

 
 
 
Clinical Observation Of ZhenQi Buxue Oral 
Liquid in Treating Menstrual Disorders 
Version 3.0 (Mar, 2022) 
Research Title：Clinical and Basic Researches Related to ZhenQi Buxue Oral Liquid in Treating 
Menstrual Disorders 
Research Leader： Aijun Sun 
Contact Tel: 18600045466 
Research Units：Peking Union Medical College Hospital 
Sichuan University West China Second University Hospital 
Chongqing Medical University No.1 Affiliated Hospital 
The Second Hospital of Hebei Medical University 
Second Affiliated Hospital of Nanchang University 
Southeast University Affiliated Zhongda Hospital 
Hubei Maternal and Child Health Hospital 
Liuzhou Maternity and Child Healthcare Hospital 
Zhejiang University Medical College Affiliated Hangzhou First People's Hospital 
Guangzhou Women and Children's Medical Center 
 
1. Research Backgrounds and purposes 
Menstrual disorders are a common disease, and the incidence is increasing year by year under 
the social background of modern general mental and psychological pressure. The most common 
causes of menstrual disorders are various psychological and spiritual factors, age factors, iatrogenic 
factors, etc. The clinical manifestations mainly include oligomenorrhea, amenorrhea, and decreased 
menstrual flow. Western medicine generally uses hormone supplementation to treat menstrual 
disorders. At present, the clinical treatment of menstrual disorders is mainly based on progesterone 

supplementation, which can protect the uterus and effectively control the amount of bleeding. The 
theory of traditional Chinese medicine believes that menstrual irregularities are related to people's 
constitution, and the foundation of menstruation regulation is to nourish the kidneys as the first 
method. Clinically, Zhenqi Buxue Oral Liquid is mainly used for dizziness, pale complexion, fatigue, 
lack of energy and lazy speech caused by insufficient qi and blood. , ginger, jujube. The excipients 
are protein sugar and sodium benzoate. Sheep placenta has the effect of regulating vitality, 
nourishing essence and blood, and can invigorate kidney qi, nourish essence and blood, and improve 
the vitality of the body; pearls can soothe the nerves and calm panic; coix seed and ginseng can 
replenish vitality, nourish blood and promote body fluid; Strengthens the surface and strengthens 
the muscles; Angelica has the effects of invigorating the spleen and stomach, nourishing qi and 
promoting body fluid, nourishing blood and soothing the nerves. Therefore, it has a certain 
theoretical basis of traditional Chinese medicine for the treatment of mental and psychological 
factors or women's menstrual disorders. This study intends to compare the treatment of Yimaxin 
(progesterone capsule) and Zhenqi Buxue oral liquid, and analyze and compare the improvement of 
symptoms, signs and various inspection indicators related to menstrual disorders between the two 
groups after treatment. Provide more reasonable and safer treatment methods. 
2.Research process and methods 
This clinical study was conducted in multiple centers such as Peking Union Medical College 
Hospital, Chinese Academy of Medical Sciences; West China Second Affiliated Hospital of West 
China Medical University; First Affiliated Hospital of Chongqing Medical University; and Second 
Affiliated Hospital of Hebei Medical University. Patients diagnosed with menstrual disorders were 
divided into 3 groups according to the type of medication, namely: Group A (Zhenqi Group): Zhenqi 
Buxue Oral Liquid was taken orally, 10 ml per time, 2 per day times*3 menstrual cycles, orally; 
Group B (Progesterone group): Yimaxin 200 mg once a day for 10 days*3 menstrual cycles, orally; 
Group C (combination group): Zhenqi Buxue Oral Liquid, orally , 10 ml at a time, 2 times a day * 
3 menstrual cycles + oral Yimaxin 200mg once a day * 10 days * 3 menstrual cycles from the second 
half of the menstrual cycle. The clinical study lasted for 3 months, and the follow-up was conducted 
once a month (before the medication, after the first month of medication and after the third month 
of medication, and after the second month, followed by telephone or WeChat follow-up), during 
your participation in the study You will take Zhenqi Buxue Oral Liquid or Yimaxin according to the 

doctor's order. From the first day you agree to participate in this study, you will receive a subject 
diary card issued by the doctor in charge, and follow the doctor's request. Complete it daily and 
submit it to the doctor in charge at each hospital visit. During the whole clinical research process, it 
is necessary to complete various physical examinations, laboratory tests and corresponding auxiliary 
examinations according to the requirements of the competent doctor (respectively before taking the 
medicine, 1 month and 3 months after taking the medicine). , 3 months), about 15-20 ml of venous 
blood each time (including sex hormones (mainly FSH, LH and E2 and AMH, liver and kidney 
function tests, etc.).  
3. Benefit from participating in the research:  
During the research, you will receive free related examinations for menstrual disorders, Zhenqi 
Buxue Oral Liquid and Yimaxin drugs for free; during the research, the doctor will monitor your 
condition throughout the whole process, and give you timely advice. 
This study will not bring risks and discomforts other than disease treatment to the subjects 
participating in the study. During the study, the doctor will monitor your condition throughout the 
whole process, and follow up after 1 month of taking the medicine. Patients can consult the research 
unit at any time regarding the discomfort during the treatment. In the event of side effects related to 
the test drug, we will provide free diagnosis and treatment and corresponding compensation 
according to national regulations. 
4. Relevant details consulting: 
You have the right to inquire about the research content, and if you have any questions about 
the research situation or your rights, or if you think there is any situation related to this research, 
please contact your doctor in charge. And you have the right to consult about your rights or related 
risks, consultation telephone (ethical review committee telephone): 69155817. 
5. Right to withdraw from research: 
Your participation in this study is completely voluntary. You may withdraw from the study at 
any time without reason, and your unwillingness to participate or continue to participate in the study 
will not affect your rights in any way. Additionally, you have the right to withdraw from this study 
at any time. (The doctor or investigator may also ask you to withdraw if you do not follow your 
doctor's instructions, or if your doctor is concerned about your health and well-being.) 
6. Confidential: 

Your medical information from this study will be kept confidential. Research results are also 
published in academic journals without revealing any personally identifiable information. Peking 
Union Medical College Hospital will keep all of your records in this study and related hospital and 
office records, and no one should have access to this information without authorization. When 
necessary, the sponsor of the trial project, the ethics committee, and the government management 
department may consult the data of the subjects participating in the research according to regulations. 
 
Signature（Subject）___________             Date：___________ 
Signature（Researcher）___________          Date：___________ 

Clinical Observation Of ZhenQi Buxue Oral 
Liquid in Treating Menstrual Disorders 
Version 3.0 (Mar, 2022) 
Research Title：Clinical and Basic Researches Related to ZhenQi Buxue Oral Liquid in Treating 
Menstrual Disorders 
Research Leader： Aijun Sun 
Contact Tel: 18600045466 
Research Units：Peking Union Medical College Hospital 
Sichuan University West China Second University Hospital 
Chongqing Medical University No.1 Affiliated Hospital 
The Second Hospital of Hebei Medical University 
Second Affiliated Hospital of Nanchang University 
Southeast University Affiliated Zhongda Hospital 
Hubei Maternal and Child Health Hospital 
Liuzhou Maternity and Child Healthcare Hospital 
Zhejiang University Medical College Affiliated Hangzhou First People's Hospital 
Guangzhou Women and Children's Medical Center 
 
 

CONTENTS 
 
A. OBJECT 
B. STUDY METHOD AND DESIGN 
C. TECHNICAL ROUTE 
D. STATISTICS ANALYSIS 
E. QUALITY CONTROL MEASUREMENT AND RESULT PUBLICATION 
F. SOURCE(S) OF FUNDING 
 
 

A． OBJECT 
Menstrual disorders are one of the most common clinical symptoms in women. Since puberty, 
about 70% of women have experienced menstrual disorders, including early, delayed, shortened, 
prolonged, and more importantly oligomenorrhea, amenorrhea, and decreased menstrual flow.At 
present, the main method of western medicine for the treatment of menstrual disorders is hormone 
replacement therapy, but the incidence of adverse reactions is high, and the clinical effect is 
mediocre. Traditional Chinese medicine in my country mostly adopts holistic conditioning therapy 
for the treatment of irregular menstruation. 
Zhenqi Buxue Oral Liquid consists of sheep placenta, pearl, red ginseng, wolfberry, astragalus, 
angelica, coix seed, ginger and jujube. The excipients are protein sugar and sodium benzoate. 
Nourishes qi and blood. It is suitable for dizziness, pale complexion, fatigue, lack of energy and 
lazy words caused by insufficient qi and blood. This study will conduct a comprehensive and in-
depth study on its treatment of mental and psychological stress and menstrual disorders with 
"oligomenorrhea, amenorrhea, amenorrhea and decreased menstrual flow" as the main 
manifestations. The molecular mechanism and clinical improvement, and the safety and adverse 
reactions of its use paln to be clarified. 
 
B. STUDY METHOD AND DESIGN 
➢ 
330 women with menstrual disorders were observed in a prospective multi-center 
randomized controlled clinical trial. 
➢ 
Inclusion Criteria: 
1) 
Aged between 25 and 40 years old; 
2) 
Patients with oligomenorrhea or oligomenorrhea or menopause within three months 
(see Appendix 1: Diagnostic Criteria of Traditional Chinese and Western Medicine) 
3) 
Meet the clinical medication conditions for progesterone to regulate menstruation 
4) 
The research subjects were informed and voluntarily participated in this study, and 
signed the informed consent at the same time. 
➢ 
Exclusion Criteria: 
1) 
Age <25 years or >40 years old, pregnant or breastfeeding women 
2) 
Ovarian dysfunction caused by local ovarian surgery, radiotherapy and 

chemotherapy 
for 
previous 
malignant 
tumors, 
taking 
hormones 
or 
immunosuppressive drugs; 
3) 
Combined with serious or unstable physical diseases that may affect the efficacy of 
drugs and the conduct of trials, including liver, kidney, gastrointestinal, 
cardiovascular, respiratory, endocrine, neurological, immune or blood system 
diseases, etc., mental patients . 
4) 
Those who were allergic to the drugs used in the trial or had serious adverse reactions 
in the past; 
5) 
Breast cancer or family history of breast cancer in first-degree relatives, irregular 
vaginal bleeding, uterine fibroids (≥3cm), endometriosis, atypical endometrial 
hyperplasia, endometrial cancer and other hormone-dependent reproduction 
Systemic diseases and other malignant tumors; 
6) 
Those with a history of thromboembolic disease or thrombosis; 
7) 
Participated in a clinical trial of another research drug within 3 months prior to 
inclusion in this study (the first interview); 
8) 
Those who have used related drugs in the past 3 months or have abused or depended 
on substances (alcohol or drugs) in the past 3 months; heavy smokers (smokers who 
smoke 20 or more cigarettes per day); 
9) 
Those who met the inclusion criteria, did not follow the doctor's advice, were unable 
to judge the curative effect or were unable to evaluate the curative effect due to 
incomplete data. 
➢ 
Methods: The participants were divided randomly into 3 groups: 
1) 
Experimental group1(Zhenqi Buxue Oral Liquid): Zhenqi Buxue Oral Liquid, 10 ml 
each time, 2 times a day for 3 menstrual cycles, orally 
2) 
Experimental group2(Zhenqi Buxue Oral Liquid and Progesterone Capsules): 
Zhenqi Buxue Oral Liquid was taken orally, 10 ml at a time, twice a day for 3 
menstrual cycles + orally from the second half of menstrual cycle, Progesterone 
Capsules 200mg, once a day for 10 days for 3 menstrual cycles 
3) 
Active Comparator group (Progesterone Capsules): Progesterone Capsules 200mg, 
qd*10 days*3 menstrual cycles, orally  

➢ 
Treatment Period: 3 month. 
➢ 
Outcomes Measurement: 
1) 
Primary Outcome: Menstrual improvement in women including cycle period, 
menstrual volume，number of days with bleeding or spotting, monthly rates of 
amenorrhea 
2) 
Secondary Outcome: 
a) 
Sex hormone levels: mainly FSH, LH，E2 and AMH 
b) 
AFC: Changes in AFC in pelvic ultrasonography 
c) 
SF-36: The change of the MOS item short from health survey 
3) 
Safety Assessment: Adverse reactions, Hepatic Function, Renal Function, Blood 
Glucose, Breast Ultrasound 
 
C. TECHNICAL ROUTE 
Screening Period (Day -30~0) 
a) The researcher explained the research situation and informed the subjects, and the subjects signed 
the informed consent; 
b) Evaluate whether subjects can enter the study according to the inclusion and exclusion criteria; 
c) Collect basic information, medical history (including menstrual history, pregnancy and birth 
history) and demographic data, conduct routine physical examination (heart rate, blood pressure, 
height, weight); and irregular menstrual symptoms and scoring 
d) On the 2nd to 3rd day of the menstrual cycle (basic day), draw venous blood to check FSH, LH, 
E2, prolactin (PRL), testosterone (T), and AMH; 
e) Liver and kidney function; 
f) Pelvic ultrasound: on the 1st to 3rd day after menstruation is clean, after disinfection of the vulva, 
transvaginal ultrasound is performed to count bilateral ovarian AFC, breast ultrasound; 
g) The investigator and the subject agree on the time of the next follow-up visit. 
Enrollment (Day 1) 
a) Re-evaluate whether the subjects can enter the study according to the test and examination results 
during the screening period, referring to the inclusion and exclusion criteria; 
b) Subjects were enrolled and received medicines according to the random number table; 

c) The investigator and the subject agree on the time of the next follow-up visit. 
Follow-up 1 ( equivalent to the end of the first month) 
a) Ask and record adverse events that have occurred since enrollment; 
b) Ask the patient about the first menstrual condition (menstrual period, cycle, menstrual volume) 
and symptoms of irregular menstruation after taking the medicine and make a score; 
c) The investigator and the subject agree on the time of the next follow-up visit. 
Follow-up 2 (After taking the medicine in the second month, follow-up by WeChat or 
telephone) 
a) Ask and record adverse events that have occurred since enrollment; 
b) Ask the patient about the second menstrual condition (menstrual period, cycle, menstrual volume) 
and the symptoms of irregular menstruation after taking the medicine and make a score; 
c) The investigator and the subject agree on the time of the next follow-up visit. 
Follow-up 3 (the third month after taking the medicine, equivalent to the end of the third 
month) 
a) Ask and record adverse events that have occurred since enrollment; 
b) perform routine physical examinations (heart rate, blood pressure, weight); 
c) Ask the patient about the current menstruation and irregular menstruation symptoms, (or 
pregnancy), perform symptom scores, and evaluate the effectiveness of the drug; 
d) FSH, LH, E2, PRL, T, AMH (blood draw on day 2-3 of menstruation); 
e) Liver and kidney function; 
f) Pelvic ultrasound (bilateral ovarian AFC) examination, breast ultrasound; 
g) Subject returns untaken medication and checks (including used medication packaging) and filled 
diary card. 
 
D. STATISTICS ANALYSIS 
Data was analyzed using SPSS Version 25. All quantitative information are expressed as mean 
values ± standard deviation (SD). Statistical significance was assessed using unpaired Student’s t-
test or chi-square test. Probability values of less than 0.05 were considered significant and an 
asterisk identifies such significance in the figures. We will also compare the adverse effect of each 
group using descriptive statistics. 

 
E. QUALITY CONTROL MEASUREMENT AND RESULT PUBLICATION 
1. 
Every center of the research possesses the competence of scientific research to conduct clinical 
studies. Special people from each center will be put in charge of the research and monitoring 
the whole procedure. The rights and interests, responsibility and obligation of all centers will 
be standardized with the research agreement. 
2. 
The maintenance, secrecy and safety of data and informations will beguaranteed by 
Department of Obsterics and Gynecology, Peking Union Medical College Hospital. 
3. 
Every center is responsible to subject enrollment and finish the prospective follow up. 
4. 
The researchers' findings will be released in a paper published online. 
 
F. SOURCE(S) OF FUNDING 
1. This study does not charge any fee to any patients.  
2. All the investigational drugs and cost of the study are provided by Qian Jin Pharmaceutical CO., 
LTD.