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In the placebo-controlled evaluation of kimbe Rukang tablet in treating hyperplasia of mammary glands (phlegm and blood stasis) randomized, double-blind efficacy and safety of single simulation, parallel controlled, multicenter phase II clinical trials

In the placebo-controlled evaluation of kimbe Rukang tablet in treating hyperplasia of mammary glands (phlegm and blood stasis) randomized, double-blind efficacy and safety of single simulation, parallel controlled, multicenter phase II clinical trials

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IIR-17011106
Enrollment
Unknown
Registered
2017-04-10
Start date
2017-05-31
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperplasia of mammary glands (phlegm and blood stasis syndrome)

Interventions

High dose group:High dose of Jinbei Breastcare
low dose group:Low dose of Jinbei Breastcare
Control group:Placebo

Sponsors

Beijing Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 55 Years

Inclusion criteria

Inclusion criteria: 1. accord with the diagnostic criteria of hyperplasia of mammary glands; 2. conform to the standard of TCM syndrome differentiation of phlegm and blood stasis syndrome; 3. ultrasound nodule size greater than 0.3cm and less than 1cm or ultrasound cystic nodules larger than 0.3cm and less than 1.5cm; 4. During the 4 cleaning period, the pain score of VAS any more than 4 cent; 5. The 5 BI-RADS classification of breast nodules less than 3 level and consideration of nodular hyperplasia; 6. between the ages of 18 to 55 years of age (including the age of 18 and between women), there are basic rules of the menstrual cycle and menstrual period of the woman; 7. subjects were informed consent, voluntary trial and signed informed consent.

Exclusion criteria

Exclusion criteria: 1. patients with breast cancer, inflammatory disease and other endocrine diseases; 2. menstrual cycles or periods of severe irregularity (menstrual cycles > 35 days and days and / or periods of "less than 3 days or" 7 days "). 3. liver function, renal function of a super normal value of the upper limit; 4. during the trial, the use of contraceptive drugs and the use of hormone drugs within three months before screening; 5. before the screening of a month to take the treatment of the disease of Chinese and Western medicine; 6. combined with cardiovascular and cerebrovascular diseases, liver, kidney, hematopoietic system and other serious primary diseases, or psychiatric patients; 7. prepare for pregnancy, pregnancy, lactation and menopausal women; 8. allergic to or known to be allergic to the drug or component; 9. alcohol abuse and other drug abuse history (alcoholism standards: men drink more than 50 grams of alcohol per day, women drink more than 30 grams of alcohol per day; drug abuse through clinical symptoms to determine; 10. to participate in other clinical trials in the past 1 months; 11. the researchers found it inappropriate to participate in the trial.

Design outcomes

Primary

MeasureTime frame
Breast size changes;

Countries

China

Contacts

Public ContactDr. Zhang

Beijing Hospital of Traditional Chinese Medicine

Morningdong@163.com+86 13811077684

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026