Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT04767620 |
Other study ID # |
AHQU-2021002 |
Secondary ID |
|
Status |
Recruiting |
Phase |
Phase 2
|
First received |
|
Last updated |
|
Start date |
March 1, 2021 |
Est. completion date |
December 31, 2021 |
Study information
Verified date |
February 2021 |
Source |
Affiliated Hospital of Qinghai University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
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.
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.