Clinical Trial of Ruxian Zengsheng No. 1 Decoction

February 21, 2021 updated by: Jiuda Zhao

A Prospective, Open, Randomized, Controlled Phase Ⅱ Clinical Study of Ruxian Zengsheng No. 1 Decoction in Treating Liver-stagnation and Qi-stagnation Hyperplasia of Breast

A prospective, open, randomized, controlled phase II clinical study is planned to clarify the efficacy and related adverse reactions of Mammary Glandular Hyperplasia No. 1 Decoction in the treatment of liver-qi stagnation type breast hyperplasia, relieve the pain of patients with breast hyperplasia, and improve the quality of life of patients.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

  1. This study is a prospective, open, randomized, controlled Phase II clinical study. Strictly follow the design requirements of the clinical research, randomly enroll patients, control each link of the study with high quality, and obtain objective research results to improve the evidence-based medicine evidence of the breast hyperplasia treatment of liver-stagnation and qi stagnation type breast hyperplasia with Rugongshengsheng No.1 prescription;
  2. Recruiting 137 patients with liver-stagnation and qi stagnation type breast hyperplasia through the Breast Center Clinic of the Affiliated Hospital of Qinghai University (see the inclusion criteria for details) (see the research plan for the specific calculation method), and randomly divided into 91 cases according to the 2:1 random number method Group, 46 cases of control group. The research group was treated with No.1 Rugdenzengsheng prescription for a total of 1 course of treatment, each course of 14 days, avoiding the menstrual period. The control group was given observation treatment and follow-up in outpatient clinic. All patients will be followed up by telephone or outpatient by a dedicated person, and the results of the follow-up will be recorded objectively;
  3. Specific treatment plan: The study group was treated with Mammary gland Hyperplasia No. 1 orally, a total of 1 course of treatment, each course of 14 days, avoiding the menstrual period. The specific composition of Mammary Gland Hyperplasia No. 1 Recipe: Angelica 10g, Radix Paeoniae Alba 10g, Atractylodes Macrocephala 10g, Ginger 3g, Peppermint 6g, Vinegar Green Peel 6g, Lychee Seed 12g, Tangerine Seed 10g, Corydalis 10g, Fritillaria 6g, Trichosanthis 10g, Kombu 20g , Mustard seeds 10g, Moutan bark 6g, Poria 10g, Beibuihu 6g. Method of administration: 14 doses in total, taken twice a day. The medicine is formulated in the herbal medicine room of the Affiliated Hospital of Qinghai University, with strict quality control;
  4. All patients will be followed up by telephone or on-site within one week after treatment. The evaluation criteria are detailed in the attached table. The curative effect evaluation standard of hyperplasia of mammary glands is mainly through the scoring method. The analgesic curative effect standard (NRS score on the most painful day): clinical recovery: the pain disappears completely; marked effect: the pain is significantly reduced, only occasional pain or only slight tenderness; effective : Pain is reduced or tenderness is reduced; Ineffective: Pain remains unchanged or worsened. In addition, collect clinical pathological data of patients, such as age, gender, reproductive history, menstrual history, family history, breastfeeding history, etc.;
  5. Secondary efficacy indicators: safety evaluation, safety endpoints include the incidence of adverse events and adverse reactions, liver function, renal function and urine routine laboratory examinations before and after treatment;
  6. Apply for ethical review by the ethics committee of the Affiliated Hospital of Qinghai University, and conduct research in strict accordance with the ethical requirements of the ethics committee of the Affiliated Hospital of Qinghai University.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
137

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Xining, Qinghai
      • Qinghai, Xining, Qinghai, China, 810000
        • Recruiting
        • Qinghai University Affiliated Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Healthy women over 18 years of age;
  2. Patients who meet the diagnostic criteria for breast color Doppler ultrasound diagnosis of breast hyperplasia and the course of disease exceeds 3 months;
  3. Meet the syndrome differentiation criteria for liver-stagnation and qi stagnation (main symptoms are ① breast distension Pain and pain; ② breast pain and/or lumps are related to menstruation and mood changes; ③ irritability and irritability; ④ flank fullness. Secondary symptoms: ① the lumps are single, soft and tender; ② Young women; ③Irregular menstruation or dysmenorrhea; ④Pale red tongue, thin white or thin yellow coating, stringy pulse. With 3 main symptoms or 2 main symptoms + 2 secondary symptoms);
  4. breast color ultrasound, breast molybdenum Target, or breast MRI showed BI-RADS 2-3;
  5. NRS (0-10 pain rating) score ≥ 4 points on the most painful day before treatment, according to the score, the pain is divided into mild 3 points, moderate Grade 4-6 points, severe 7-10 points;
  6. Voluntarily participate in the clinical study and sign the informed consent form after the informed consent (patients voluntarily accept the study and sign the informed consent).

Exclusion Criteria:

  1. Patients with other breast diseases or other causes of breast pain (such as mastitis, breast cancer, etc.);
  2. Patients with severe cardiovascular and cerebrovascular diseases, liver, kidney, malignant tumors, blood system diseases, and Patients with mental illness;
  3. Patients who have been confirmed to have dysfunctional uterine bleeding, amenorrhea, polycystic ovary syndrome, menopausal syndrome and hyperprolactinemia before treatment, still need to regulate hormone levels for treatment;
  4. Patients diagnosed with hypercortisolism before treatment still need bromocriptine treatment;
  5. Menstrual period is more than 7 days, menopause and severe irregular menstrual cycle;
  6. ALT, AST, ALP, TBIL , GGT is higher than the upper limit of normal; or abnormal blood, urine, electrocardiogram and other examination items;
  7. pregnant or breastfeeding women, or patients with pregnancy plans in the next six months;
  8. 1 before treatment Use Chinese or Western medicine to treat breast hyperplasia (including painkillers, topical drugs, acupuncture, etc.) within the month and during the treatment period, and use hormonal drugs (except for long-term use), and oral contraceptives within six months;
  9. People who are known to be allergic to the ingredients of the test drug prescription;
  10. Past alcohol or drug abuse history;
  11. Patients who participated in other clinical studies within 3 months before enrollment;
  12. According to the judgment of the researchers, there are other diseases Or circumstances will reduce the possibility of enrollment or complicate enrollment. For example, frequent changes in the work environment may cause loss to follow-up, and patients with mental and behavioral disorders, or the inability to sign informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: study groups
The study group was treated with Rugdenzengsheng No. 1 prescription for 2 courses.
Drug: Rugdenzengsheng No. 1 prescription
The study group was treated with the No. 1 Mammary Gland Growth Recipe orally, a total of 1 course of treatment, each course of 14 days, avoiding the menstrual period. The specific composition of Mammary Gland Hyperplasia No. 1 Recipe: Angelica 10g, Radix Paeoniae Alba 10g, Atractylodes Macrocephala 10g, Ginger 3g, Peppermint 6g, Vinegar Green Peel 6g, Lychee Seed 12g, Tangerine Seed 10g, Corydalis 10g, Fritillaria 6g, Trichosanthis 10g, Kombu 20g , Mustard seeds 10g, Moutan bark 6g, Poria 10g, North Bupleurum 6g. Method of administration: 14 doses in total, taken twice a day. The medicine is formulated in the herbal medicine room of the Affiliated Hospital of Qinghai University, with strict quality control.
Other Names:
  • non
No Intervention: control groups
The control group was treated with observational treatment and follow-up in outpatient clinic.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Relief Rate of Mammary Gland Pain
Time Frame: 12 weeks
To clarify the effectiveness of Rugshengsheng No.1 Recipe in the Affiliated Hospital of Qinghai University in reducing the pain of patients with liver-stagnation and qi stagnation type breast hyperplasia, as well as related adverse side effects, and provide reliable clinical evidence for further clinical promotion
12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Relief time of breast pain
Time Frame: 12 weeks
Related Adverse Reactions of Rugongshengsheng No.1 Prescription
12 weeks
Related adverse reactions
Time Frame: 12 weeks
Statistic about the related adverse reactions of patients after taking the No.1 Recipe for Mammary Gland Growth, the degree and severity of the adverse reactions
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jiuda Zhao

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 9, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 21, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 23, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 23, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 21, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AHQU-2021002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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