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

Shanghai Yueyang Integrated Medicine Hospital

Status and phase: Unknown; Phase 3

Conditions: Acne Vulgaris

Treatments: Drug: Ju Yin placebo cream; Drug: BaidI Quzhi granule; Drug: Baidi Quzhi placebo granule; Drug: Ju Yin cream

Study type: Interventional

Funder types: Other

Identifiers

NCT05035979

2020045

Details and patient eligibility

About

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.

Full 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.

Enrollment: 472 estimated patients

Sex: All

Ages: 16 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 1. Patients with acne vulgaris aged from 16 to 45, male or female. 2. Patients who meet the western diagnostic criteria of mild and moderate acne vulgaris and the differentiation criteria of TCM syndrome (15,16).

3. Patients who voluntarily join this study with informed consent. 4. No acne drugs were received within 1 month, and no external drugs related to the disease were used within 1 week.

Exclusion criteria

• 1. Patients with severe primary diseases such as cerebrovascular, cardiovascular, liver, kidney and hematopoietic system.

  2. Participants will be ineligible if they ate pregnant or lactating women, and those with fertility plans in the next 2 years.

  3. Patients who do not meet the inclusion criteria, fail to use the medicine according to the regulations, fail to judge the curative effect, or incomplete data affect the judgment of curative effect or safety.

  4. Allergic constitution and allergic to the drug ingredients studied in this project.

  5. Cicatricial constitution. 6.Occupational acne caused by chemicals, acne caused by drugs.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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472 participants in 4 patient groups, including a placebo group

TCM comprehensive treatment group

Experimental group

Description:

Participants in the TCM treatment group will receive BaiDi Quzhi granule two times daily after meals, Ju Yin cream therapy three times per week for 8 weeks.

Treatment:

Drug: Ju Yin cream

Drug: BaidI Quzhi granule

TCM internal treatment group

Active Comparator group

Description:

Participants in the TCM internal treatment group will receive Baidi Quzhi granule two times daily after meals and Ju Yin placebo therapy three times per week for 8 weeks.

Treatment:

Drug: BaidI Quzhi granule

Drug: Ju Yin placebo cream

TCM external treatment group

Active Comparator group

Description:

Participants in the TCM external treatment group will receive Baidi Quzhi placebo granule two times daily after meals and Ju Yin cream therapy three times per week for 8 weeks.

Treatment:

Drug: Ju Yin cream

Drug: Baidi Quzhi placebo granule

Placebo group

Placebo Comparator group

Description:

Participants in the placebo group will receive Baidi Quzhi placebo granule two times daily after meals, Ju Yin placebo therapy three times per week for 8 weeks.

Treatment:

Drug: Baidi Quzhi placebo granule

Drug: Ju Yin placebo cream