Clinical Trial of Ruxian Zengsheng No. 1 Decoction

NCT04767620 | Unknown Phase 2 DMC

• 1 other identifier: AHQU-2021002
• Study Type: interventional
• Target: 137
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Mammary Gland Hyperplasia

Keywords

Mammary gland hyperplasia; Liver Qi stagnation

Outcome Measures

Primary Outcomes (1)

• Relief Rate of Mammary Gland Pain

  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 Outcomes (2)

• Relief time of breast pain

  12 weeks

• Related adverse reactions

  12 weeks

Study Arms (2)

study groups

EXPERIMENTAL

The study group was treated with Rugdenzengsheng No. 1 prescription for 2 courses.

Drug: Rugdenzengsheng No. 1 prescription

control groups

NO INTERVENTION

The control group was treated with observational treatment and follow-up in outpatient clinic.

Interventions

Rugdenzengsheng No. 1 prescription DRUG

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.

Also known as: non

study groups

Eligibility Criteria

• Age: 18 Years - 80 Years
• Gender Eligibility Details: Adult healthy women over 18
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy women over 18 years of age;
• Patients who meet the diagnostic criteria for breast color Doppler ultrasound diagnosis of breast hyperplasia and the course of disease exceeds 3 months;
• 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);
• breast color ultrasound, breast molybdenum Target, or breast MRI showed BI-RADS 2-3;
• 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;
• 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).

You may not qualify if:

• 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 tumors, blood system diseases, and Patients with mental illness;
• 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;
• Patients diagnosed with hypercortisolism before treatment still need bromocriptine treatment;
• Menstrual period is more than 7 days, menopause and severe irregular menstrual cycle;
• ALT, AST, ALP, TBIL , GGT is higher than the upper limit of normal; or abnormal blood, urine, electrocardiogram and other examination items;
• pregnant or breastfeeding women, or patients with pregnancy plans in the next six months;
• 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;
• People who are known to be allergic to the ingredients of the test drug prescription;
• Past alcohol or drug abuse history;
• Patients who participated in other clinical studies within 3 months before enrollment;
• 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.

Sponsors & Collaborators

• Jiuda Zhao: lead

Study Sites (1)

Qinghai University Affiliated Hospital

Qinghai, Xining, Qinghai, 810000, China

RECRUITING

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The study group took the No.1 Recipe for Rugden Zengsheng, and the control group took clinical observation and follow-up at the breast center. The study group and the control group were grouped randomly by envelope, and grouped according to 2:1.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: non

Study Record Dates

• First Submitted: February 9, 2021
• First Posted: February 23, 2021
• Study Start: March 1, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: February 23, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)