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Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：
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Case Report Form
The version number：VERSION 1.0_20211019
Random encoding ： |__|__|__|__|
Subject's initials ： |__|__|__|__|
Name of Doctor (in Block letters)： ＿＿＿
Study time： October 2021 -- October 2024
Instructions for filling in the case report form
(Please read the following instructions carefully before completing this form.)
1、This case report form must be filled in by a full-time evaluator and completed by the same person as far as possible;The doctor's signature on the front and end pages should be filled in by the investigator in charge of the case.
2、A large number of data in this CRF are obtained from the statistics, calculation and summary of the original data (subjects' urination diary card, etc.). Please be sure to check carefully and make accurate statistics and calculation to avoid manual statistical errors!
3、The subject enrollment number on the upper right corner of the cover is compiled by the researcher to facilitate monitoring and CRF management.
4、Please complete this form with pen or marker pen, not pencil or ballpoint pen.
5、The qualified candidates shall formally fill in the case report form, and the last data shall be carried forward as the last data for those who have stopped treatment, and the time and reason of withdrawal shall be truthfully recorded.
6、If there is a "□" in the table, please put an "×" in the correct "□".
7、Please fill in the number in the open box, one number in each box, if the number is not enough, please filling 0 in the front or back box. All inspection items must be filled in. Please fill in "ND" if there is no inspection/omission for some reason. Data unknown/not known, please fill in "UK"; If this option is not applicable, enter NA.
8、Method of filling in the name of the subject: The abbreviation of the name of the subject should be filled in four squares, and the first two letters of the name of the subject should be filled in the first two letters of each pinyin; Fill in the first letter and the second letter of the third word pinyin for the three-character name; Fill in the first letter of the four-character name in their pinyin; Fill in the first letter of the first four characters in pinyin. The investigator must complete a subject identity registration form to facilitate identification of subjects during and after the trial.
9、Be sure to fill in accurately and clearly, do not erase or alter at will, correct the mistakes with a horizontal line in the center, and sign the name of the modifier (physician's initials, capital letters) and the modification time, and explain the reason if necessary. Do not mask the original data you fill in, and do not allow erasers, correction fluids, or scratching out the original content. Example: fill in the wrong 2011/07/13/[year, month, day], correction model 2011/07/1314 SJF 2011/07/14 .
10、The international IS08601 date format is yyyymmdd. For example: October 15, 2010 written: 20101015. Use medical terminology when describing history and adverse events. Use the full name of the diagnosis and drug. Do not use abbreviations or abbreviations unless they are listed in the study protocol.
11、Please strictly implement the clinical trial plan, and the projects to be completed at each visit site should be carried out according to the clinical study flow chart, and pay attention to the time window.
12、The combined medication record form and adverse reaction/event record form should be truthfully filled in during the clinical study. If a serious adverse event occurs, a serious adverse event record form must be filled in regardless of whether the event is related to the study treatment or not, along with the usual treatment.
Clinical study flowchart
Phase Baseline (Weeks 1-4) Treatment time（ Weeks 5-8） Follow-up
5 weeks 6 weeks 7 weeks 8 weeks 16 weeks 32 weeks
Treatment 0 3 times 3 times 2 times 2 times
International Prostatic Symptom Scale (IPSS) √ √ √ √ √
Quality of Life evaluation
(QoL) √ √ √ √ √
Prostate volume（cm3） √ √
Post-void residual PVR（ml） √ √
Maximum flow rate Qmax（ml/s） √ √
Digital Rectal Examination（DRE） √ √
Informed consent √
Evaluation method for the blind √ √
Acupuncture safety √ √
Acupuncture
resistance √ √
Emergency medicine
Adverse events
Note: 1. "√" in this table represents the projects that must be completed by this time node.
2. In case of intermediate shedding, the most recent specialized evaluation data of the subject should be traced back as far as possible, and the phase table should be filled in in time, and the reduction loss rate should be tabled to reduce the data loss rate.
3. After observation and observation, 1 internal observation shall be audited and signed by the person in charge within a week.
4. The supervisor of the project undertaking unit shall regularly inspect and review all RCRF entry and approval forms.
First visit (1-4 weeks)
Date of visit：20 |__|__|year|__|__|month|__|__|day
Note: This date should be the date of randomization after the baseline screening of the subject (the date of enrollment). Other visit times should be based on this date.
Date of signing informed consent:
20 |__|__|year|__|__|month|__|__|day
Inclusion Criteria (If "no" is selected for any item, it will not be included in this study) Yes No
1.Meet the diagnostic criteria of BPH. ¨1 ¨0
2.Age range: 50 to 80. ¨1 ¨0
3.Those who voluntarily sign informed consent are required to participate in this study. ¨1 ¨0
Exclusion criteria (" Yes "means no inclusion in this study) Yes No
1.Unable to communicate unobstructed. ¨1 ¨0
2.Associated with urethritis, acute prostatitis, urinary calculi and other diseases. ¨1 ¨0
3.Complicated with neurogenic bladder, bladder neck fibrosis, urethral stricture and other diseases. ¨1 ¨0
4.Patients with neurological diseases or diabetes that affect urination function. ¨1 ¨0
5.Hyperplasia of prostate complicated with malignant wasting diseases such as prostate cancer and tuberculosis. ¨1 ¨0
6.Patients with serious diseases such as liver and kidney insufficiency and other heart and lung diseases and blood diseases. ¨1 ¨0
7.Patients with upper urinary tract obstruction and hydronephrosis and impaired renal function found by B-ultrasound. ¨1 ¨0
8.Have been using drugs that may affect bladder function or are receiving BPH drugs. ¨1 ¨0
9.B ultrasound or CT found excessive prostatic hyperplasia affecting acupuncture operators. ¨1 ¨0
10.B ultrasound or CT found that residual urine in the bladder was too much, which affected the acupuncture operator. ¨1 ¨0
TCM syndromes Kidney qi depletion Center qi fall Qi stagnation and blood stasis Damp-heat brewing and binding Kidney vacuity and blood stasis Kidney vacuity and damp-heat Damp-heat and blood stasis Dual vacuity of the spleen and kidney
Demographic data
Gender Men Date of birth |__|__|__|__|year
|__|__|month|__|__|day CT
serial number
National ¨1 The Han nationality ¨2 The Zhuang nationality ¨3 The Zhuang nationality ¨4 The Hui nationality ¨5 The Miao nationality ¨6 The Uygur nationality ¨7 other____
Marital status ¨1 Yes ¨2 No
Degree ¨1 Postgraduate and above ¨2 Undergraduate ¨3 College Specialist ¨4 High school/Secondary school/Technical school ¨5 Junior high school ¨6 Primary school ¨7 Illiteracy
Occupation ¨1 Worker ¨2 Farmer ¨3 Teacher ¨4 Solider ¨5 Student ¨6 Cadre ¨7 Employee ¨8 Retired ¨9 Freelance ¨10 Other____
Height |__|__|__|.|__|cm Weight |__|__|__|.|__|kg
Body mass index（BMI） |__|__|.|__| Distance between the anterior superior iliac spine on both sides |__|__|__|.|__|cm
Waist at navel level |__|__|__|.|__|cm Symphysis pubis is horizontally positioned around the buttocks |__|__|__|.|__|cm
Formula
acupuncture depth |__|__|__|.|__|mm Formula acupuncture Angle |__|__|.|__|Angle
Acupuncture depth under CT |__|__|__|.|__|mm Acupuncture Angle under CT |__|__|.|__|Angle
Contact Number 1:
Contact Number 2: Address：
Benign Prostatic Hyperplasia（BPH）Medical history
Course of the disease |__|__|year|__|__|month
The degree of BPH ¨1 Mild ¨2 Moderate ¨3 Severe
Concomitant disease ¨1No ¨2 Yes, please continue to fill in the form below.
Name of co-morbidities The start time The end of time
|__|__|__|__|year|__|__|month |__|__|__|__|year|__|__|month
Treatment of BPH Whether or not to receive treatment for BPH: ¨1No ¨2 Yes, please continue to fill in the form below.
Treatment ¨1Traditional Chinese medicine treatment ¨2Western medicine treatment ¨3The surgical treatment ¨4Other
Last treatment |__|__|__|__|year|__|__|month|__|__|day-|__|__|__|__|year|__|__|month|__|__|day
Drugs in use BPH therapy:___________; Other therapeutic drugs :_____________.
Ultrasonic prostate volume and
postvoid residual urine volume |__|__|__|__|year|__|__|month|__|__|day
Volume|__|__|__|.|__|ml, post-void residual |__|__|__|ml
|__|__|__|__|year|__|__|month|__|__|day
Volume |__|__|__|.|__|ml， post-void residual |__|__|__|ml
Determination of
maximum flow rate |__|__|__|__|year|__|__|month|__|__|day，_________ml/s
|__|__|__|__|year|__|__|month|__|__|day, _________ml/s
Efficacy evaluation index 1 2 3 4 5
International Prostate Symptom Scale（IPSS）
Symptom sign and examination score
Quality of Life score (QoL)
Acupuncture tolerance score
Questionnaire at baseline during the first visit（Week1-4）
Date of visit: 20 |__|__|year|__|__|month|__|__|day
Table 1 International Prostate Symptom Scale (IPSS)
Have you had any of the following symptoms in the last 1 month? No In the five times Symptom scores
Less than 1/5 Less than 1/2 About 1/2 More than half Almost always
1. Do you often feel like urination is not enough? 0 1 2 3 4 5
2.Are two urination intervals often less than 2 hours? 0 1 2 3 4 5
3.Do you often have intermittent urination? 0 1 2 3 4 5
4.Whether there is a phenomenon of urination cannot wait? 0 1 2 3 4 5
5.Is there any narrowing of urinary line? 0 1 2 3 4 5
6.Do you need to exert force to start urination? 0 1 2 3 4 5
7. How many times do you need to get up and urinate from falling asleep to getting up early? No Once Twice 3 times 4 times 5 times
0 1 2 3 4 5
IPSS Total score=
Table 2 Quality of Life（QoL）Scale
Symptoms Happy Satisfied Generally satisfied So-so Not satisfied distress Very bad
What do you think if you have urination symptoms for the rest of your life? 0 1 2 3 4 5 6
Quality of Life (QoL)
Table 4 Symptom signs and auxiliary examination grading scoring standard
0 1 2 3 Score
IPSS 0 1-7 8-19 20-35
DRE Normal Ⅰ° Ⅱ° Ⅲ°
QoL 0-1 2 3-4 5-6
Prostate volume（cm3） ＜18 18 ～ 25 26 ～ 45 ＞ 46
PVR（ml） ≤10 11 ～ 60 61 ～ 100 ＞ 100
Qmax（ml/s） ＞ 15 10.1～15 5 ～ 10 ＜ 5
Nocturnal urine frequency (times) 0 ～ 1 2 3 ～ 4 ≥5
Urine line status Normal Urinary fine such as line Urine into line Little drops do not make a thread
Small abdominal distension full No Occasionally Sometimes Often
Urine waiting No Occasionally Sometimes Often
Urine urgency No Can endure Bear with me for a while Can't stand
Total score
Questionnaire 2 weeks after the second visit（Week5-6）
Date of visit: 20 |__|__|year|__|__|year|__|__|day
Is the visit on schedule? ¨1Yes ¨0No The reason for the delay：
Table 1 International Prostate Symptom Scale (IPSS)
Have you had any of the following symptoms in the last 1 month? No In the five times Symptom scores
Less than 1/5 Less than 1/2 About 1/2 More than half Almost always
1. Do you often feel like urination is not enough? 0 1 2 3 4 5
2.Are two urination intervals often less than 2 hours? 0 1 2 3 4 5
3.Do you often have intermittent urination? 0 1 2 3 4 5
4.Whether there is a phenomenon of urination cannot wait? 0 1 2 3 4 5
5.Is there any narrowing of urinary line? 0 1 2 3 4 5
6.Do you need to exert force to start urination? 0 1 2 3 4 5
7. How many times do you need to get up and urinate from falling asleep to getting up early? No Once Twice 3 times 4 times 5 times
0 1 2 3 4 5
IPSS Total score=
Table 2 Quality of Life（QoL）Scale
Symptoms Happy Satisfied Generally satisfied So-so Not satisfied distress Very bad
What do you think if you have urination symptoms for the rest of your life? 0 1 2 3 4 5 6
Quality of Life (QoL)
Table 3 Acupuncture safety evaluation and acupuncture tolerance evaluation
Safety evaluation of acupuncture（Record each treatment at any time）¨1No ¨2 Yes, please continue to fill out this form
Symptom code/name occurrences Other discomfort after acupuncture Duration
|__|__|
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01= Broken needle, 02= Needle stagnation, 03= needle phobia, 04= Local hematoma, 05= Local infection, 06= Local abscess, 07= Pain.
Other discomfort after acupuncture: 08= Fatigue, 09= Heart palpitations, 10= Dizzy, 11= Headache, 12= Insomnia, 13=Other:
Evaluation method for the blind
（Evaluation after the first treatment） Acupuncture treatment ¨1Yes ¨0No
Evaluation of acupuncture tolerance（Evaluation after the first treatment）
Evaluation of acupuncture discomfort No discomfort 0--1--2--3--4--5--6--7--8--9--10 Very uncomfortable ¨¨
Evaluation of acupuncture tolerance ¨0 very difficult to accept ¨1 Take it a little harder ¨2 Can accept
¨3 Easy to accept ¨4 Very receptive
Third visit questionnaire after 4 weeks of treatment（5-8周）
Date of visit：20 |__|__|year|__|__|month|__|__|day
Is the visit on schedule? ¨1Yes ¨0No？The reason for the delay:
Table 1 International Prostate Symptom Scale (IPSS)
Have you had any of the following symptoms in the last 1 month? No In the five times Symptom scores
Less than 1/5 Less than 1/2 About 1/2 More than half Almost always
1. Do you often feel like urination is not enough? 0 1 2 3 4 5
2.Are two urination intervals often less than 2 hours? 0 1 2 3 4 5
3.Do you often have intermittent urination? 0 1 2 3 4 5
4.Whether there is a phenomenon of urination cannot wait? 0 1 2 3 4 5
5.Is there any narrowing of urinary line? 0 1 2 3 4 5
6.Do you need to exert force to start urination? 0 1 2 3 4 5
7. How many times do you need to get up and urinate from falling asleep to getting up early? No Once Twice 3 times 4 times 5 times
0 1 2 3 4 5
IPSS Total score=
Table 2 Quality of Life（QoL）Scale
Symptoms Happy Satisfied Generally satisfied So-so Not satisfied distress Very bad
What do you think if you have urination symptoms for the rest of your life? 0 1 2 3 4 5 6
Quality of Life (QoL)
Table 3 Acupuncture safety evaluation and acupuncture tolerance evaluation
Safety evaluation of acupuncture（Record each treatment at any time）¨1No ¨2 Yes, please continue to fill out this form
Symptom code/name occurrences Other discomfort after acupuncture Duration
|__|__|
|__|__|
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01= Broken needle, 02= Needle stagnation, 03= needle phobia, 04= Local hematoma, 05= Local infection, 06= Local abscess, 07= Pain.
Other discomfort after acupuncture: 08= Fatigue, 09= Heart palpitations, 10= Dizzy, 11= Headache, 12= Insomnia, 13=Other:
Evaluation method for the blind
（Evaluation after the first treatment） Acupuncture treatment ¨1Yes ¨0No
Evaluation of acupuncture tolerance（Evaluation after the first treatment）
Evaluation of acupuncture discomfort No discomfort 0--1--2--3--4--5--6--7--8--9--10 Very uncomfortable ¨¨
Evaluation of acupuncture tolerance ¨0 very difficult to accept ¨1 Take it a little harder ¨2 Can accept
¨3 Easy to accept ¨4 Very receptive
Table 4 Symptom signs and auxiliary examination grading scoring standard
0 1 2 3 Score
IPSS 0 1-7 8-19 20-35
DRE Normal Ⅰ° Ⅱ° Ⅲ°
QoL 0-1 2 3-4 5-6
Prostate volume（cm3） ＜18 18 ～ 25 26 ～ 45 ＞ 46
PVR（ml） ≤10 11 ～ 60 61 ～ 100 ＞ 100
Qmax（ml/s） ＞ 15 10.1～15 5 ～ 10 ＜ 5
Nocturnal urine frequency (times) 0 ～ 1 2 3 ～ 4 ≥5
Urine line status Normal Urinary fine such as line Urine into line Little drops do not make a thread
Small abdominal distension full No Occasionally Sometimes Often
Urine waiting No Occasionally Sometimes Often
Urine urgency No Can endure Bear with me for a while Can't stand
Total score
Follow-up questionnaire 2 months after the end of the fourth visit（Week9-16）
Date of visit: 20 |__|__|year|__|__|month|__|__|day
Is the visit on schedule? ¨1Yes ¨0No？The reason for the delay:
Table 1 International Prostate Symptom Scale (IPSS)
Have you had any of the following symptoms in the last 1 month? No In the five times Symptom scores
Less than 1/5 Less than 1/2 About 1/2 More than half Almost always
1. Do you often feel like urination is not enough? 0 1 2 3 4 5
2.Are two urination intervals often less than 2 hours? 0 1 2 3 4 5
3.Do you often have intermittent urination? 0 1 2 3 4 5
4.Whether there is a phenomenon of urination cannot wait? 0 1 2 3 4 5
5.Is there any narrowing of urinary line? 0 1 2 3 4 5
6.Do you need to exert force to start urination? 0 1 2 3 4 5
7. How many times do you need to get up and urinate from falling asleep to getting up early? No Once Twice 3 times 4 times 5 times
0 1 2 3 4 5
IPSS Total score=
Table 2 Quality of Life（QoL）Scale
Symptoms Happy Satisfied Generally satisfied So-so Not satisfied distress Very bad
What do you think if you have urination symptoms for the rest of your life? 0 1 2 3 4 5 6
Quality of Life (QoL)
Follow-up questionnaire 6 months after the end of the fifth visit（Week 17-32）
Date for visit: 20 |__|__|year|__|__|month|__|__|day
Is the visit on schedule? ¨1Yes ¨0No？Reason for delay:
Table 1 International Prostate Symptom Scale (IPSS)
Have you had any of the following symptoms in the last 1 month? No In the five times Symptom scores
Less than 1/5 Less than 1/2 About 1/2 More than half Almost always
1. Do you often feel like urination is not enough? 0 1 2 3 4 5
2.Are two urination intervals often less than 2 hours? 0 1 2 3 4 5
3.Do you often have intermittent urination? 0 1 2 3 4 5
4.Whether there is a phenomenon of urination cannot wait? 0 1 2 3 4 5
5.Is there any narrowing of urinary line? 0 1 2 3 4 5
6.Do you need to exert force to start urination? 0 1 2 3 4 5
7. How many times do you need to get up and urinate from falling asleep to getting up early? No Once Twice 3 times 4 times 5 times
0 1 2 3 4 5
IPSS Total score=
Table 2 Quality of Life（QoL）Scale
Symptoms Happy Satisfied Generally satisfied So-so Not satisfied distress Very bad
What do you think if you have urination symptoms for the rest of your life? 0 1 2 3 4 5 6
Quality of Life (QoL)
Drug combination: Were any western drugs other than BHP used during the study period?
¨0No，□1Yes，fill in the table below:
Number Drug name Indications
Whether medication is used for adverse events Dosage form A single dose Unit dose
Dosing frequency Delivery way Start date Does the end of the study last?
Yes No→End date
1 □1
2 □1
3 □1
4 □1
5 □1
6 □1
7 □1
8 □1
9 □1
Dosage form code CA=Capsule
TB=Tablets
GTTS=Drops
AMP=Ampoule
OT=Other
Unit code of dosage form
ug=Microgram
mg=Milligram
ml=Milliliter
g= Gram
OT=Other
Dosing frequency code
QD=Once daily
BID=Twice daily TID=3 times daily
QID=4 times daily
QOD=Every other day
QN=Once a night
Q8H=Every 8 hours
Q12H=Every 12 hours
PRN=When necessary
OT=Other
Route of administration code PO=Take orally
TOP=Topical
SC=Subcutaneous
IV=Intravenous
IM=Intramuscular
PR=Rectal administration
NG=Nasal feeding
IT=Intrathecal
IA=Intra-articular
SL=Sublingual
INH=Inhalation
IO=Intraocular
TD=Percutaneous
OT=Other
Adverse events: Were there any adverse events throughout the study period? (Except for the discomfort listed in the safety evaluation) Have you experienced any discomfort since your last treatment? ¨0No, ¨1Yes, fill in the following form:
Number Description of adverse events
Does the end of the study last? severity Correlation with acupuncture treatment Measures taken for acupuncture treatment Take other measures outcome Whether or not SAE？
Yes No→End date No Yes→End date
1 □0
2 □0
3 □0
4 □0
5 □0
6 □0
7 □0
8 □0
9 □0
Association of adverse events with acupuncture treatment 1=Definitely relevant
2=Probably related
3=May be relevant
4=May not be relevant
5=Definitely irrelevant Measures taken for acupuncture treatment 1=not applicable
2=No change
3=Reduce frequency /Reduces irritation
4=Pause the needle stabbing treatment 5=Stop acupuncture permanently
Take other measures
1=No
2=For hospitalization or extended hospitalization, fill out SAE form
3=For combined medication, fill in the area of combined medication
4=Please describe others. The outcome of AE
1=Recovery, no sequelae
2=Recovery, with sequelae
3=Ease
4=Continuous/no change
5=Aggravation/deterioration
6=Death
7=The unknown
The specific type of SAE
1=Cause of death
2=Life-threatening
3=Resulting in or prolonged hospitalization
4=Cause permanent or significant disability/loss of function
5=Cause congenital malformations
6=Other important medical events
Summary of research completion
Date of first treatment: 20 |__|__|year|__|__|month|__|__|day
Date of last treatment: 20 |__|__|year|__|__|month|__|__|day
Whether the subjects completed the 4-week study according to the study protocol
¨1Yes
¨0No, end date：20 |__|__|year|__|__|month|__|__|day, and fill in the following reasons for the suspension of the test.
The main reasons for the suspension of the trial are: (choose one of the most important reasons)
¨1Breach of protocol (any breach of protocol will be assessed by the investigator to determine whether it is serious enough to withdraw from the study), please describe in detail_____________
¨2Adverse events, number|__|__|(Adverse event form has been filled out.)
¨3Although there were no adverse events, discontinuation of treatment was considered in the subjects' best interest due to safety concerns.
¨4Lack of efficacy
¨5Withdrawal of informed consent by patients (including withdrawal by patients themselves)
¨6Patients were lost to follow-up
¨7Other reasons: _____________
Number of treatments Week 1 Week 2 Week 3 Week 4 Total
Number of times should be treated
Actual number of treatments
Case Report Form (CRF) review Statement
1、Confirm that the subject has signed the informed consent.
2、Confirm that the subject's name, mailing address and telephone number are true and complete.
3、Confirm that subjects meet the protocol inclusion criteria and do not meet the exclusion criteria.
4、Verify that treatment records are correct for subjects' group.
5、Confirm that all items in the study record are completely filled in, physical and chemical inspection results are complete, the original inspection report has been pasted on the "Test Sheet Paste page", and the "Report Form of Physical and chemical Inspection Results" has been correctly filled in.
6、Verify that all adverse events have been completed in the Adverse Event Form. Adverse events and physical and chemical examination data that were normal before and after treatment but could not be explained by deterioration of the disease were reviewed and followed up to normal
7、Confirm that subjects' withdrawal and loss of follow-up have been truthfully filled in the "Disengagement reason Form".
8、When it is confirmed that there is an error, mark the error value with “—”, write the correct value above the error, the modifier signs and notes the date, the reason for the change has been explained, and no original data has been covered.
Signature of professional evaluator: _____________ Date of signing: 20 |__|__|year|__|__|month|__|__|day
Quality control doctor's signature: _____________ Date of signing: 20 |__|__|year|__|__|month|__|__|day
Principal investigator statement
I reviewed all the records in this case report form page by page and item by item. I confirmed that these data were true, complete and accurate, consistent with the original data and in line with the design requirements of the study protocol. All the data recording work was done by me and my designee and we signed the researcher signature form.
Principal investigator signature: _____________ Date of signing: 20 |__|__|year|__|__|month|__|__|day
Check the adhesion of the test sheet：
1.Blood routine examination
2.Urine-RT.
3.Liver function Ⅰ.
4.Renal function Ⅰ.
5.B ultrasound prostate volume.
6.Bladder residual urine.
7.Urinary flow rate(Qmax).
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