Fibrocystic Disease of BreastPhase 4NCT02929420
A Clinical Study on the Efficacy and Safety of the Treatment of Hyperplasia of Mammary Glands With Xiaoru Sanjie Capsule
A Phase 4 study testing Xiaoru Sanjie capsules and Xiao Yao pills in people with Fibrocystic Disease of Breast, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of Xiaoru Sanjie capsule in the treatment of cyclomastopathy. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Fibrocystic Disease of Breast
- What is being tested?
- Xiaoru Sanjie capsules and Xiao Yao pills
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- Oct 2016to Dec 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-65 years old female patients with cyclomastopathy who signed a written informed consent.
- The subjects voluntarily entered the clinical observation whom are hospitalized patients or outpatients with good compliance.
- They have specific symptoms, such as distending pain of the breast, stabbing pain, dull pain and radiating pain.
- They have specific physical sign, for example, we can touch block gland, granular, nodular or cord like glands and etc..
- Breast ultrasound or molybdenum target show I-III class by Breast Imaging Reporting and Data System.
Who cannot join
- Women who are pregnant or lactating, and who has the history of periarthritis of shoulder.
- Excluding breast fibrocellular tumor, breast cancer and other breast diseases.
- Patients with poor self coordination, mentally retarded patients, or have cardiovascular and cerebrovascular disease, severe organic disease, as well as the hematopoietic system disease or mental illness.
- Be judged as over middle degree depression by the Hamilton's depression scale.
- Allergic constitution patients, and people who are allergic to a variety of drugs.
- Any medical history which may interfere with the test results or increase the risk of patients according to the investigators.
- Patients who have received treatment of other diseases, and those treatment methods and targets may have an impact on the indicators of this study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Yu Ren
Xi'an, Shaanxi, 710000
Yu Ren, MD, PhD, 13700222161, renyyyyy@126.com
About this study
Official title: A Multicenter, Randomized, Open, Parallel Controlled Clinical Study on the Efficacy and Safety of the Treatment of Cyclomastopathy With Xiaoru Sanjie Capsule
The purpose of this study is to evaluate the efficacy and safety of Xiaoru Sanjie capsule in the treatment of cyclomastopathy.
Read the detailed description
This is a multicenter, randomized, open and parallel controlled clinical study.
- Conditions
- Fibrocystic Disease of Breast
- Being tested
- Xiaoru Sanjie capsules, Xiao Yao pills
- Keywords
- Multicenter, randomized, open, parallel controlled
- Medical subject headings
- Fibrocystic Breast Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xiaoru Sanjie capsulesDrug
Also called Xiaoru Sanjie capsule
Oral medication for a total of 90 days. According to the instructions, P.O., three times a day, each time three tablets, take a month as a treatment course, continuous use of 3 courses.
Xiao Yao pillsDrug
Also called ease pills
Oral medication for a total of 90 days. According to the instructions, P.O., three times a day, each time three tablets, take a month as a treatment course, continuous use of 3 courses.
| Study group | Role | What they receive |
|---|---|---|
| Xiaoru Sanjie capsules | Experimental | a new recipe of traditional chinese medicine； Xiaoru Sanjie capsules,three pills every time,three time a day,PO, last three months. Receives: Drug: Xiaoru Sanjie capsules |
| Xiao Yao pills | Placebo comparator | a kind of traditional chinese medicine that is efficient and safe to treat hyperplasia of mammary glands.
Xiaoyao pills,three pills every time,three time a day,PO,last three months. Receives: Drug: Xiao Yao pills |
What is being measured
The primary outcome is the main question the study is designed to answer.
the size of breast lumps
Assess the size of breast lumps by breast ultrasonography or breast molybdenum target.
Measured: after 30 days' treatment
the size of breast lumps
Assess the size of breast lumps by breast ultrasonography or breast molybdenum target.
Measured: after 60 days' treatment
the size of breast lumps
Assess the size of breast lumps by breast ultrasonography or breast molybdenum target.
Measured: after 90 days' treatment
the scope of breast lumps
Assess the scope of breast lumps by breast ultrasonography or breast molybdenum target.
Measured: after 30 days' treatment
the scope of breast lumps
Assess the scope of breast lumps by breast ultrasonography or breast molybdenum target.
Measured: after 60 days' treatment
the scope of breast lumps
Assess the scope of breast lumps by breast ultrasonography or breast molybdenum target.
Measured: after 90 days' treatment
the hardness of breast lumps
Assess the hardness of breast lumps by breast ultrasonography or breast molybdenum target.
Measured: after 30 days' treatment
the hardness of breast lumps
Assess the hardness of breast lumps by breast ultrasonography or breast molybdenum target.
Measured: after 60 days' treatment
the hardness of breast lumps
Assess the hardness of breast lumps by breast ultrasonography or breast molybdenum target.
Measured: after 90 days' treatment
pain of breast
According to hyperplasia of mammary glands efficacy appraisal standard of 2002 china association of chinese medicine surgery branch.
Measured: after 30 days' treatment
pain of breast
According to hyperplasia of mammary glands efficacy appraisal standard of 2002 china association of chinese medicine surgery branch.
Measured: after 60 days' treatment
pain of breast
According to hyperplasia of mammary glands efficacy appraisal standard of 2002 china association of chinese medicine surgery branch.
Measured: after 90 days' treatment
Secondary outcomes (12)
all adverse reactions after taking Xiaoru Sanjie capsule
Number of Participants with different adverse reactions after taking treatment.
Measured: after 30 days' treatment
all adverse reactions after taking Xiaoru Sanjie capsule
Number of Participants with different adverse reactions after taking treatment.
Measured: after 60 days' treatment
all adverse reactions after taking Xiaoru Sanjie capsule
Number of Participants with different adverse reactions after taking treatment.
Measured: after 90 days' treatment
the level of estrogen
Measured: after 30 days' treatment
the level of estrogen
Measured: after 60 days' treatment
the level of estrogen
Measured: after 90 days' treatment
the level of progestin
Measured: after 30 days' treatment
the level of progestin
Measured: after 60 days' treatment
the level of progestin
Measured: after 90 days' treatment
the level of prolactin
Measured: after 30 days' treatment
the level of prolactin
Measured: after 60 days' treatment
the level of prolactin
Measured: after 90 days' treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2016 (estimated)
- Study startOct 2016
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fibrocystic Disease of BreastStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yu Ren, MD,PhD, Principal investigator, First Affiliated Hospital Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02929420
- Sponsor's protocol ID
- ry-2016-08
- Status last verified
- Aug 2016
- First submitted
- 23 Aug 2016
- Last updated
- 11 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Open, Parallel Controlled Clinical Study on the Efficacy and Safety of the Treatment of Cyclomastopathy With Xiaoru Sanjie Capsule
- ClinicalTrials.gov ID
- NCT02929420
- Acronym / sponsor ID
- ry-2016-08
- Conditions
- Fibrocystic Disease of Breast
- Keywords
- Multicenter, randomized, open, parallel controlled
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 11 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the efficacy and safety of Xiaoru Sanjie capsule in the treatment of cyclomastopathy.
Detailed description
This is a multicenter, randomized, open and parallel controlled clinical study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Xiaoru Sanjie capsules | Experimental | Drug: Xiaoru Sanjie capsulesa new recipe of traditional chinese medicine； Xiaoru Sanjie capsules,three pills every time,three time a day,PO, last three months. |
| Xiao Yao pills | Placebo comparator | Drug: Xiao Yao pillsa kind of traditional chinese medicine that is efficient and safe to treat hyperplasia of mammary glands. Xiaoyao pills,three pills every time,three time a day,PO,last three months. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18-65 years old female patients with cyclomastopathy who signed a written informed consent.
- The subjects voluntarily entered the clinical observation whom are hospitalized patients or outpatients with good compliance.
- They have specific symptoms, such as distending pain of the breast, stabbing pain, dull pain and radiating pain.
- They have specific physical sign, for example, we can touch block gland, granular, nodular or cord like glands and etc..
- Breast ultrasound or molybdenum target show I-III class by Breast Imaging Reporting and Data System.
Key exclusion criteria (7 listed)
- Women who are pregnant or lactating, and who has the history of periarthritis of shoulder.
- Excluding breast fibrocellular tumor, breast cancer and other breast diseases.
- Patients with poor self coordination, mentally retarded patients, or have cardiovascular and cerebrovascular disease, severe organic disease, as well as the hematopoietic system disease or mental illness.
- Be judged as over middle degree depression by the Hamilton's depression scale.
- Allergic constitution patients, and people who are allergic to a variety of drugs.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Xiaoru Sanjie capsulesAlso: Xiaoru Sanjie capsuleOral medication for a total of 90 days. According to the instructions, P.O., three times a day, each time three tablets, take a month as a treatment course, continuous use of 3 courses. | Drug | Xiaoru Sanjie capsules |
| Xiao Yao pillsAlso: ease pillsOral medication for a total of 90 days. According to the instructions, P.O., three times a day, each time three tablets, take a month as a treatment course, continuous use of 3 courses. | Drug | Xiao Yao pills |
Primary outcome
the size of breast lumps
Time frame: after 30 days' treatment
Assess the size of breast lumps by breast ultrasonography or breast molybdenum target.
the size of breast lumps
Time frame: after 60 days' treatment
Assess the size of breast lumps by breast ultrasonography or breast molybdenum target.
the size of breast lumps
Time frame: after 90 days' treatment
Assess the size of breast lumps by breast ultrasonography or breast molybdenum target.
the scope of breast lumps
Time frame: after 30 days' treatment
Assess the scope of breast lumps by breast ultrasonography or breast molybdenum target.
the scope of breast lumps
Time frame: after 60 days' treatment
Assess the scope of breast lumps by breast ultrasonography or breast molybdenum target.
the scope of breast lumps
Time frame: after 90 days' treatment
Assess the scope of breast lumps by breast ultrasonography or breast molybdenum target.
the hardness of breast lumps
Time frame: after 30 days' treatment
Assess the hardness of breast lumps by breast ultrasonography or breast molybdenum target.
the hardness of breast lumps
Time frame: after 60 days' treatment
Assess the hardness of breast lumps by breast ultrasonography or breast molybdenum target.
the hardness of breast lumps
Time frame: after 90 days' treatment
Assess the hardness of breast lumps by breast ultrasonography or breast molybdenum target.
pain of breast
Time frame: after 30 days' treatment
According to hyperplasia of mammary glands efficacy appraisal standard of 2002 china association of chinese medicine surgery branch.
pain of breast
Time frame: after 60 days' treatment
According to hyperplasia of mammary glands efficacy appraisal standard of 2002 china association of chinese medicine surgery branch.
pain of breast
Time frame: after 90 days' treatment
According to hyperplasia of mammary glands efficacy appraisal standard of 2002 china association of chinese medicine surgery branch.
12 secondary outcomes
all adverse reactions after taking Xiaoru Sanjie capsule
Time frame: after 30 days' treatment
all adverse reactions after taking Xiaoru Sanjie capsule
Time frame: after 60 days' treatment
all adverse reactions after taking Xiaoru Sanjie capsule
Time frame: after 90 days' treatment
the level of estrogen
Time frame: after 30 days' treatment
the level of estrogen
Time frame: after 60 days' treatment
the level of estrogen
Time frame: after 90 days' treatment
the level of progestin
Time frame: after 30 days' treatment
the level of progestin
Time frame: after 60 days' treatment
the level of progestin
Time frame: after 90 days' treatment
the level of prolactin
Time frame: after 30 days' treatment
the level of prolactin
Time frame: after 60 days' treatment
the level of prolactin
Time frame: after 90 days' treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2016.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yu Ren, MD,PhD principal investigator
First Affiliated Hospital Xi'an Jiaotong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Xiaoru Sanjie capsules and Xiao Yao pills in people with Fibrocystic Disease of Breast, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yu Ren (13700222161, renyyyyy@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the size of breast lumps (time frame: after 30 days' treatment). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2016.