Oral Baidi Quzhi Granule Combined With Ju Ying Cream for Acne Vulgaris

Last updated: September 3, 2021
Sponsor: Shanghai Yueyang Integrated Medicine Hospital
Overall Status: Active - Not Recruiting

Phase

3

Condition

Rash

Acne

Inflammatory Comedones

Treatment

N/A

Clinical Study ID

NCT05035979
2020045
  • Ages 16-45
  • All Genders

Study Summary

We designed the study as a double-blind,randomized,controlled clinical trial.The aim of this trial is to clarify the treatment efficacy, safety, and recurrence control of BaiDi QuZhi(BDQZ) granule combined with Ju Yin(JY) cream in the treatment of acne vulgaris.

Eligibility Criteria

Inclusion

Inclusion Criteria:

    1. Patients with acne vulgaris aged from 16 to 45, male or female. 2. Patients who meetthe western diagnostic criteria of mild and moderate acne vulgaris and the differentiationcriteria of TCM syndrome (15,16).
  1. Patients who voluntarily join this study with informed consent. 4. No acne drugs werereceived within 1 month, and no external drugs related to the disease were used within 1week.

Exclusion

Exclusion Criteria:

    1. Patients with severe primary diseases such as cerebrovascular, cardiovascular,liver, kidney and hematopoietic system.
  1. Participants will be ineligible if they ate pregnant or lactating women, and thosewith fertility plans in the next 2 years.
  2. Patients who do not meet the inclusion criteria, fail to use the medicine accordingto the regulations, fail to judge the curative effect, or incomplete data affect thejudgment of curative effect or safety.
  3. Allergic constitution and allergic to the drug ingredients studied in this project.
  4. Cicatricial constitution. 6.Occupational acne caused by chemicals, acne caused bydrugs.

Study Design

Total Participants: 472
Study Start date:
December 01, 2021
Estimated Completion Date:
August 31, 2023

Study Description

Acne is a chronic inflammatory skin disease of hair follicle and sebaceous gland, which is common in adolescents and adults.Systemic drugs commonly used in the treatment of acne include isotretinoin, oral antibiotics and hormone preparations. Isotretinoin is the first choice for the treatment of moderate and severe acne, but its use is limited by its adverse reactions such as cheilitis, elevated blood lipids and teratogenicity .The efficacy of BDQZ granule in the treatment of acne is accurate. However, large-scale randomized controlled trials have not been conducted on the efficacy, safety and recurrence of BDQZ granule. Therefore, our aim was to conduct a multicenter, randomized, double-blind, placebo-controlled clinical trial of oral BDQZ granule combined with JY cream in the treatment of acne vulgaris.