Hyperplasia of BreastPhase 2NCT04229706
A Study of Xiangjurupining Capsule in the Treatment of Hyperplasia of Breast (Liver Stagnation and Phlegm Coagulation)
A Phase 2 study testing High dose Xiang Ju Ru Pi Ning capsule and Low dose Xiang Ju Ru Pi Ning capsule in people with Hyperplasia of Breast, run by Tasly Pharmaceutical Group Co., Ltd at 8 sites in China.
Trial summary
The study is to evaluate the efficacy and safety of two doses of xiangjurupining capsule in Hyperplastic disease of breast patients . Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Hyperplasia of Breast
- What is being tested?
- High dose Xiang Ju Ru Pi Ning capsule and Low dose Xiang Ju Ru Pi Ning capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 8 sitesChina
- Study dates
- 31 Dec 2019to 15 Jan 2022
- Phase
- Phase 2
- 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 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female patients aged 18-50 years.
- Those who meet the diagnostic criteria of breast hyperplasia and has a course of more than 3 months;
- Conform to the syndrome differentiation standard of liver depression and phlegm coagulation;
- Patients have a basic regular menstrual cycle (21-35 days) and a menstrual period (3-7 days)
- BI-RADS grade 2-3
- NRS score ≥ 4 points in screening period
- The average score of NRS was ≥ 4 in the run-in period, and there was still a target lump in palpation
- Volunteer to participate in the experiment and sign the informed consent form after informed consent（Patients voluntarily accepted the test and gave informed consent）
Who cannot join
- Patients with other breast diseases or other causes of breast pain, such as mastitis, breast cancer, etc.
- Patients with severe cardiovascular and cerebrovascular diseases, liver, kidney, malignant tumor, blood system diseases and mental diseases.
- Patients who have been confirmed with dysfunctional uterine bleeding, amenorrhea, polycystic ovary syndrome, menopausal syndrome and hyperprolactinemia before, still need to be treated by regulating hormone level.
- Patients with previously confirmed hypercortisolism who still need to be treated with bromocriptine.
- Those with menstrual period more than 7 days, menopause and serious irregular menstrual cycle.
- Alt, AST, ALP, TBIL, GGT more than 1.2 times the upper limit of normal value; serum Cr, bun more than 1.2 times the upper limit of normal value, or blood, urine routine, ECG and other examination items are abnormal and of clinical significance.
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- That who pregnant or lactating women, or have a pregnant plan within the next 6 months
- Chinese or Western medicine was used to treat hyperplasia of mammary gland within 1 month before the treatment and during run-in period(including external application medicine, acupuncture, etc.) and hormone drugs have been used within half a year (except for long-term oral contraceptives).
- Allergic constitution, known to be allergic to the ingredients of the prescription of the test drug
- History of alcohol or drug abuse.
- Participants in other clinical trials within 3 months before screening
- According to the judgment of the researchers, there are other diseases or situations that reduce the possibility of enrollment or complicate the enrollment, such as frequent changes in the working environment, which are likely to cause lost visits, and people with mental and behavioral disorders that cannot be based on the full informed consent.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
China8 sites
Baoding No.1 Hospital of TCM
Baoding
Dongfang Hospital ,Beijing University of Chinese Medicine
Beijing
Dongzhimen Hospital,Beijing University of Chinese Medicine
Beijing
Guangdong Provincial Hospital of TCM
Guangzhou
the First Affiliated Hospital of Guangzhou University of TCM
Guangzhou
Longhua Hospital, Shanghai University of Traditional Chinese Medicine
Shanghai
SHUGUANG Hospital, Shanghai University of Traditional Chinese Medicine
Shanghai
Weifang Traditional Chinese Hospital
Weifang
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Multicenter Phase II Clinical Study on the Efficacy and Safety of Xiangjurupining Capsule in the Treatment of Hyperplasia of Breast (Liver Stagnation and Phlegm Coagulation)
The study is to evaluate the efficacy and safety of two doses of xiangjurupining capsule in Hyperplastic disease of breast patients .
Read the detailed description
The study is to evaluate the efficacy and safety of two doses of xiangjurupining capsule,give three times a day versus placebo in Hyperplastic disease of breast patients .The clinical phase of the study comprises a run-in period，an 3-months double-blind treatment period and a 1-month follow-up period, resulting in 5-months overall duration of the study for each patient.
Patients report their breast pain as measured using NRS scale on the subject daily diary。
- Conditions
- Hyperplasia of Breast
- Being tested
- High dose Xiang Ju Ru Pi Ning capsule, Low dose Xiang Ju Ru Pi Ning capsule, Xiang Ju Ru Pi Ning capsule placebo
- Keywords
- hyperplasia of breast, Xiangjurupining capsule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High dose Xiang Ju Ru Pi Ning capsuleDrug
Also called High dose group
xingjurupining capsule,8 capsule,tid,3 months.
Low dose Xiang Ju Ru Pi Ning capsuleDrug
Also called Low dose group
xiangjurupining capsule,4 capsules , and xiangjurupining capsule placebo,4 capsules,tid,3 months.
Xiang Ju Ru Pi Ning capsule placeboDrug
Also called Placebo group
xiangjurupining capsule,8 capsule,tid,3 months.
| Study group | Role | What they receive |
|---|---|---|
| High dose group | Experimental | xiangjurupining capsule ,8 capsules，tid Receives: Drug: High dose Xiang Ju Ru Pi Ning capsule |
| Lower dose group | Experimental | xiangjurupining capsule, 4 capsules,tid, xiangjurupining capsule placebo ,4 capsules，tid，po Receives: Drug: Low dose Xiang Ju Ru Pi Ning capsule |
| Placebo group | Placebo comparator | xiangjurupining capsule placebo ,8 capsules，tid，po Receives: Drug: Xiang Ju Ru Pi Ning capsule placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The pain of breast
Subject reported breast pain using NRS( Numerical Rating Scale)scale on the subject daily diary..The NRS scale is a line composed of 11 points, marked with a scale of 0 to 10. The subjects rated themselves according to the most painful degree every day. The higher the score, the higher the degree of pain.
Measured: up to 3 months
The days of pain
Subject reported breast pain as measured using NRS scale on the subject daily diary.The number of the pain days was calculated and compared with the baseline which the number of pain days in the lead-in period.
Measured: up to 3 months
The target lump
Assess the scope ,the size and the hardness of the target lump by palpation.The doctor palpated the breast of the subjects and measured the size of the target lump with a ruler.Four quadrant method was used to record the number of the target lump's quadrants.Four level（0,2,4,6） to measure The scope,the size and the hardness of lump .the Score from 0(none) to 6(most severe).
Measured: 3 months after treatment
The target lump area
Assess the breast glandular section thickness, breast duct width and nodules of the target lump area by B-ultrasound.
Measured: 3 months after treatment
TCM syndrome scores
Compared wth baseline,the scores of changes of TCM syndrome Evaluation at each visit .This instrument consists of two primary symptoms: breast pain, breast mass ,and four secondary symptoms.Four levels to measure severity of primary symptoms（0、2、4、6）and secondary symptoms（0、1、2、3）, respectively. Record the tongue and pulse conditions. The TCM syndrome effect calculated by nimodipine method. The final score has a range of 0 to 100. The effect of TCM syndrome from 0% (negative ) to 100% (disappear).
Measured: 3 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start31 Dec 2019
- Primary completion12 Jan 2022
- Study completion15 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hyperplasia of BreastStudies of the same condition, open and under way.
- More trials run by Tasly Pharmaceutical Group Co., LtdThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tasly Pharmaceutical Group Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04229706
- Sponsor's protocol ID
- TSL-TCM-XJRPNJN-Ⅱ
- Status last verified
- Aug 2024
- First submitted
- 8 Jan 2020
- Last updated
- 5 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Multicenter Phase II Clinical Study on the Efficacy and Safety of Xiangjurupining Capsule in the Treatment of Hyperplasia of Breast (Liver Stagnation and Phlegm Coagulation)
- ClinicalTrials.gov ID
- NCT04229706
- Acronym / sponsor ID
- TSL-TCM-XJRPNJN-Ⅱ
- Conditions
- Hyperplasia of Breast
- Keywords
- hyperplasia of breast, Xiangjurupining capsule
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Tasly Pharmaceutical Group Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 31 Dec 2019 (actual)
- Primary completion
- 12 Jan 2022 (actual)
- Study completion
- 15 Jan 2022 (actual)
- First posted
- 18 Jan 2020 (actual)
- 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 study is to evaluate the efficacy and safety of two doses of xiangjurupining capsule in Hyperplastic disease of breast patients .
Detailed description
The study is to evaluate the efficacy and safety of two doses of xiangjurupining capsule,give three times a day versus placebo in Hyperplastic disease of breast patients .The clinical phase of the study comprises a run-in period，an 3-months double-blind treatment period and a 1-month follow-up period, resulting in 5-months overall duration of the study for each patient.
Patients report their breast pain as measured using NRS scale on the subject daily diary。
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High dose group | Experimental | Drug: High dose Xiang Ju Ru Pi Ning capsulexiangjurupining capsule ,8 capsules，tid |
| Lower dose group | Experimental | Drug: Low dose Xiang Ju Ru Pi Ning capsulexiangjurupining capsule, 4 capsules,tid, xiangjurupining capsule placebo ,4 capsules，tid，po |
| Placebo group | Placebo comparator | Drug: Xiang Ju Ru Pi Ning capsule placeboxiangjurupining capsule placebo ,8 capsules，tid，po |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Female patients aged 18-50 years.
- Those who meet the diagnostic criteria of breast hyperplasia and has a course of more than 3 months;
- Conform to the syndrome differentiation standard of liver depression and phlegm coagulation;
- Patients have a basic regular menstrual cycle (21-35 days) and a menstrual period (3-7 days)
- BI-RADS grade 2-3
Key exclusion criteria (12 listed)
- Patients with other breast diseases or other causes of breast pain, such as mastitis, breast cancer, etc.
- Patients with severe cardiovascular and cerebrovascular diseases, liver, kidney, malignant tumor, blood system diseases and mental diseases.
- Patients who have been confirmed with dysfunctional uterine bleeding, amenorrhea, polycystic ovary syndrome, menopausal syndrome and hyperprolactinemia before, still need to be treated by regulating hormone level.
- Patients with previously confirmed hypercortisolism who still need to be treated with bromocriptine.
- Those with menstrual period more than 7 days, menopause and serious irregular menstrual cycle.
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 |
|---|---|---|
| High dose Xiang Ju Ru Pi Ning capsuleAlso: High dose groupxingjurupining capsule,8 capsule,tid,3 months. | Drug | High dose group |
| Low dose Xiang Ju Ru Pi Ning capsuleAlso: Low dose groupxiangjurupining capsule,4 capsules , and xiangjurupining capsule placebo,4 capsules,tid,3 months. | Drug | Lower dose group |
| Xiang Ju Ru Pi Ning capsule placeboAlso: Placebo groupxiangjurupining capsule,8 capsule,tid,3 months. | Drug | Placebo group |
Primary outcome
The pain of breast
Time frame: up to 3 months
Subject reported breast pain using NRS( Numerical Rating Scale)scale on the subject daily diary..The NRS scale is a line composed of 11 points, marked with a scale of 0 to 10. The subjects rated themselves according to the most painful degree every day. The higher the score, the higher the degree of pain.
The days of pain
Time frame: up to 3 months
Subject reported breast pain as measured using NRS scale on the subject daily diary.The number of the pain days was calculated and compared with the baseline which the number of pain days in the lead-in period.
The target lump
Time frame: 3 months after treatment
Assess the scope ,the size and the hardness of the target lump by palpation.The doctor palpated the breast of the subjects and measured the size of the target lump with a ruler.Four quadrant method was used to record the number of the target lump's quadrants.Four level（0,2,4,6） to measure The scope,the size and the hardness of lump .the Score from 0(none) to 6(most severe).
The target lump area
Time frame: 3 months after treatment
Assess the breast glandular section thickness, breast duct width and nodules of the target lump area by B-ultrasound.
TCM syndrome scores
Time frame: 3 months after treatment
Compared wth baseline,the scores of changes of TCM syndrome Evaluation at each visit .This instrument consists of two primary symptoms: breast pain, breast mass ,and four secondary symptoms.Four levels to measure severity of primary symptoms（0、2、4、6）and secondary symptoms（0、1、2、3）, respectively. Record the tongue and pulse conditions. The TCM syndrome effect calculated by nimodipine method. The final score has a range of 0 to 100. The effect of TCM syndrome from 0% (negative ) to 100% (disappear).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing High dose Xiang Ju Ru Pi Ning capsule and Low dose Xiang Ju Ru Pi Ning capsule in people with Hyperplasia of Breast, run by Tasly Pharmaceutical Group Co., Ltd at 8 sites 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 8 inclusion and 12 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: finished, as of the sponsor's last update on 5 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The pain of breast (time frame: up to 3 months). The study lists 5 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 5 Sep 2024.