Plain English Summary
Background and study aims
Breast pain, with different degrees of pain in the breast, belongs to the category of "lump in breast" in traditional Chinese medicine. It mainly includes two types: periodic breast pain and non-periodic breast pain. Cyclical pain is the most common type to date, and the incidence can account for 70% of breast pain. The clinical manifestations are diffused pain or tenderness in one or both breasts, and breast swelling may increase or decrease with the menstrual cycle. It seriously affects the quality of life of women. Hormone therapy is usually used in clinical practice, but the side effects are usually significant, and long-term use may interfere with endocrine regulation. The Chinese herbal medicine Hongjin Xiaojie capsule belongs to Chinese patent medicine. It is known as the "female holy medicine" and has the effect of detumescence and pain, soft firmness and loose knot, promoting blood circulation and removing blood stasis, soothing liver and regulating qi. Hongjin Xiaojie capsule is originated from the century-old minority Yi folk medicine classics, and is widely used in Yi nationality areas, especially in Yunnan province. It was approved as a herbal drug by the China Food and Drug Administration in 1999, and it was included in the Guidelines for Clinical Application of Chinese Medicines in 2017. It is listed as an optional Chinese patent medicine for breast pain. The aim of this study is to evaluate the clinical effectiveness and safety of Chinese patent medicine Hongjin Xiaojie capsule in the treatment of breast pain.
Who can participate?
Premenopausal or perimenopausal women with breast pain aged 18 to 55 years old
What does the study involve?
Participants are randomly allocated into two groups. One group receives Hongjin Xiaojie capsule for three months (not taking the medicine during menstruation). The other group receives no treatment during the first three months. After three months, the participants in the waiting list group can volunteer to take the test medicine for three months.
What are the possible benefits and risks of participating?
If successful, the medicine has the potential to preserve and enhance the benefits of rehabilitation for women with breast pain. This may reduce hospital admissions and improve their quality of life. There may be some minor adverse effect associated with this medicine in a few patients.
Where is the study run from?
1. The Third Affiliated Hospital of Beijing University of Chinese Medicine, Beijing, China
2. Beijing Fang Shan District Hospital of Chinese Medicine, Beijing, China
3. Sichuan Second Hospital of Traditional Chinese Medicine, Chengdu, Sichuan, China
4. Shuguang Hospital Affiliated to Shanghai University of Chinese Medicine, Shanghai, China
When is the study starting and how long is it expected to run for?
August 2019 to December 2020
Who is funding the study?
Yunnan Yousheng Pharmaceutical Co., Ltd. (China)
Who is the main contact?
1. Jian-ping Liu (Scientific)
Liujp@bucm.edu.cn
2. Xiao-hua Pei (Public)
pxh_127@163.com
Trial website
Contact information
Type
Scientific
Primary contact
Prof Jian-ping Liu
ORCID ID
http://orcid.org/0000-0002-0320-061X
Contact details
11 Bei San Huan Dong Lu
Chaoyang District
Beijing
100029
China
+86 (0)10 64286760
Liujp@bucm.edu.cn
Type
Public
Additional contact
Prof Xiao-hua Pei
ORCID ID
Contact details
No. 51
Xiao Guan Jie
An Ding Men Wai
Chaoyang District
Beijing
100029
China
+86 (0)13911683278
pxh_127@163.com
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
Nil known
Study information
Scientific title
Effectiveness and safety of Hongjin Xiaojie Capsule versus waiting list for breast pain: a multi-center, randomized controlled trial
Acronym
Study hypothesis
Compared with no treatment, Chinese herbal medicine Hongjin Xiaojie capsule may be effective and safe for relieving breast pain in women.
Ethics approval
Approved 31/07/2019; IRB of The Third Affiliated Hospital, Beijing University of Chinese Medicine (No. 51 Xiao Guan Jie, An Ding Men Wai, Chaoyang District, Beijing; Tel: +86 (0)10-52075242; Email: zydsyky@126.com); Approval number: BZYSY-2019KYKTPJ-05
Study design
Multicentre randomized clinical trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Breast pain
Intervention
Participants will be randomly allocated into two groups. The method of randomisation: central randomisation run by the leading clinical site (3rd Affiliated Hospital of Beijing University of Chinese Medicine), and the generation of allocation sequence was developed by random number tables.
The treatment group will receive Hongjin Xiaojie capsules for three months (stop taking this medicine during menstruation), 3 times/day
The control (waiting list) group will receive no treatment during the first three months. After three months, the participants can volunteer to take the tested medicine for three months
The dosage given: 4 capsules/time, three times per day
Co-intervention (analgesic drug) will be allowed if patients feel pain not well controlled
The total duration of follow-up: 24 weeks ± 3 days
Intervention type
Drug
Phase
Phase IV
Drug names
Primary outcome measure
1. The degree of breast pain measured using short-form of McGill questionnaire (SF-MPQ) at baseline, 4 weeks ± 3 days (duration of treatment), 8 weeks ± 3 days (duration of treatment), 12 weeks ± 3 days (end of treatment), 24 weeks ± 3 days (end of follow-up)
2. The duration of pain: the number of days of breast pain during each menstrual cycle measured at baseline, 4 weeks ± 3 days (duration of treatment), 8 weeks ± 3 days (duration of treatment), 12 weeks ± 3 days (end of treatment), 24 weeks ± 3 days (end of follow-up)
Secondary outcome measures
1. Breast nodule size: the size of the nodule is determined by both palpation and B-ultrasound at baseline, 12 weeks ± 3 days (end of treatment)
2. Hysteromyoma size (if complicated): abdominal uterus colour ultrasound is used for examination and measurement at baseline, 12 weeks ± 3 days (end of treatment)
3. Menstrual conditions: including menstrual bleeding volume, menstrual cycle, dysmenorrhea, etc, measured at baseline, 4 weeks ± 3 days (duration of treatment), 8 weeks ± 3 days (duration of treatment), 12 weeks ± 3 days (end of treatment), 24 weeks ± 3 days (end of follow-up)
4. Safety outcome indicators:
4.1. General physical examination items measured at baseline, 12 weeks ± 3 days (end of treatment)
4.2. Blood, urine, stool routine samples at baseline, 12 weeks ± 3 days (end of treatment)
4.3. Electrocardiogram, liver and kidney function measured using blood biochemical tests at baseline, 12 weeks ± 3 days (end of treatment)
4.4. Other symptoms and signs other than pain measured using patient diary at 4 weeks ± 3 days (duration of treatment), 8 weeks ± 3 days (duration of treatment), 12 weeks ± 3 days (end of treatment), 24 weeks ± 3 days (end of follow-up)
Overall trial start date
01/08/2019
Overall trial end date
31/12/2020
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. 18 - 55 years old, female, pre- or peri-menopause
2. Meeting the diagnostic criteria of breast pain; including women with breast nodules, the longest diameter of B-ultrasonic solid nodules ≤2cm or the longest diameter of B-ultrasonic cystic nodules ≤2 cm
3. The number of days of breast pain for each menstrual cycle is equal or longer than 3 days and visual analog scale (VAS) ≥ 4 points; if treated before, the pain symptom could not relieve for three consecutive menstrual cycles or more
4. Women diagnosed as hysteromyoma according to the diagnostic criteria of hysteromyoma will be included
5. The menstrual cycle and the menstrual period are basically regular, and the menstrual cycle is about 28 ± 7 days
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
294
Participant exclusion criteria
1. Women who are preparing for pregnancy or who are pregnant or lactating
2. Patients with allergic constitution, or allergic to the test drug or its components
3. Breast image report and data system (BI-RADS) classification > level 3
4. Patients with breast malignant tumors, inflammatory diseases and other endocrine diseases (such as pituitary tumors)
5. Taking contraceptives during the trial and using hormonal drugs within the first three months of screening
6. Those who have taken Chinese or Western medicines to treat this disease within 1 month before screening or those who participated in other clinical drug trials
7. Patients with severe primary diseases including cardiovascular, cerebrovascular, liver, kidney and hematopoietic system, or patients with mental illness
Recruitment start date
01/10/2019
Recruitment end date
30/06/2020
Locations
Countries of recruitment
China
Trial participating centre
The Third Hospital Affiliated to Beijing University of Chinese Medicine
No. 51, Xiaoguan Street outside Andingmen, Chaoyang District
Beijing
100029
China
Trial participating centre
Beijing fangshan district hospital of Chinese medicine
No. 151, Chengguan South Street, Fangshan District
Beijing
100029
China
Trial participating centre
Sichuan Second Hospital of Traditional Chinese Medicine
No. 20, Sidao Street, Qingyang District
Chengdu
610000
China
Trial participating centre
Shuguang Hospital Affiliated to Shanghai University of Chinese Medicine
No. 185, Pu’an road, Huangpu district
Shanghai
200000
China
Sponsor information
Organisation
Yunnan Yousheng Pharmaceutical Co., Ltd
Sponsor details
Xichong
Liujie Town
Yimen County
Yuxi
653100
China
+86 (0)18801067775
yujun0821@163.com
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Yunnan Yousheng Pharmaceutical Co., Ltd
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer-reviewed journal, approximately December 2020.
IPD sharing statement
The data sharing plans for the current study are limited upon the contract with the company and might be made available upon agreement from the company. Data requests will be directed to Prof Jian-ping Liu at the Centre for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, China; Tel: +86 (0)10 64286760; Email: Liujp@bucm.edu.cn. Since this trial was sponsored by the pharmaceutical company (Yunnan Yousheng) and there is a contract between the company and the trial institutions, any request of data will need approval through the negotiation of the PI and the company and in accordance with the regulation of ethical and personal privacy policy in China.
Intention to publish date
31/12/2020
Participant level data
Available on request
Basic results (scientific)
Publication list