Clinical Trial of Ruxian Zengsheng No. 1 Decoction
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
Sponsor study identifier
interventional
137
1 country
1
Study Start
March 1, 2021
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Primary Completion
December 31, 2021
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Study Completion
December 31, 2021
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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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2021
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 9, 2021
Actual (reported)February 23, 2021
Actual (reported)March 1, 2021
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December 31, 2021
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December 31, 2021
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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
Relief time of breast pain
12 weeks
Related adverse reactions
12 weeks
The study group was treated with Rugdenzengsheng No. 1 prescription for 2 courses.
The control group was treated with observational treatment and follow-up in outpatient clinic.
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.
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Qinghai University Affiliated Hospital
Qinghai, Xining, Qinghai, 810000, China
First Submitted
February 9, 2021
First Posted
February 23, 2021
Study Start
March 1, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Contact the study team to confirm eligibility.
Primary Completion
December 31, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 31, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
February 23, 2021
Record last verified: 2021-02
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