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

NCT ID: NCT05035979

Last Updated: 2021-09-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 472 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-01
• Study Completion Date: 2023-08-31

Brief 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.

Detailed 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.

Conditions

Acne Vulgaris

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

TCM comprehensive treatment group

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.

Group Type: EXPERIMENTAL

BaidI Quzhi granule

Intervention Type: DRUG

Put each bag of medicine in one day into the same container, pour in about 50ml of warm water, stir until the granules are basically dissolved, add some boiled water to dilute, and take it twice.

Ju Yin cream

Intervention Type: DRUG

Take JY cream 5g evenly applied to the face, negative ion spray at the same time acupoint massage along the meridian, apply 10min, clean the face with water, 3 times a week.

TCM internal treatment group

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.

Group Type: ACTIVE_COMPARATOR

BaidI Quzhi granule

Intervention Type: DRUG

Put each bag of medicine in one day into the same container, pour in about 50ml of warm water, stir until the granules are basically dissolved, add some boiled water to dilute, and take it twice.

Ju Yin placebo cream

Intervention Type: DRUG

Take JY placebo cream 5g evenly applied to the face, negative ion spray at the same time acupoint massage along the meridian, apply 10min, clean the face with water, 3 times a week.

TCM external treatment group

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.

Group Type: ACTIVE_COMPARATOR

Ju Yin cream

Intervention Type: DRUG

Take JY cream 5g evenly applied to the face, negative ion spray at the same time acupoint massage along the meridian, apply 10min, clean the face with water, 3 times a week.

Baidi Quzhi placebo granule

Intervention Type: DRUG

Put each bag of medicine in one day into the same container, pour in about 50ml of warm water, stir until the granules are basically dissolved, add some boiled water to dilute, and take it twice.

Placebo group

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.

Group Type: PLACEBO_COMPARATOR

Baidi Quzhi placebo granule

Intervention Type: DRUG

Put each bag of medicine in one day into the same container, pour in about 50ml of warm water, stir until the granules are basically dissolved, add some boiled water to dilute, and take it twice.

Ju Yin placebo cream

Intervention Type: DRUG

Take JY placebo cream 5g evenly applied to the face, negative ion spray at the same time acupoint massage along the meridian, apply 10min, clean the face with water, 3 times a week.

Interventions

BaidI Quzhi granule

Put each bag of medicine in one day into the same container, pour in about 50ml of warm water, stir until the granules are basically dissolved, add some boiled water to dilute, and take it twice.

Intervention Type: DRUG

Ju Yin cream

Take JY cream 5g evenly applied to the face, negative ion spray at the same time acupoint massage along the meridian, apply 10min, clean the face with water, 3 times a week.

Intervention Type: DRUG

Baidi Quzhi placebo granule

Put each bag of medicine in one day into the same container, pour in about 50ml of warm water, stir until the granules are basically dissolved, add some boiled water to dilute, and take it twice.

Intervention Type: DRUG

Ju Yin placebo cream

Take JY placebo cream 5g evenly applied to the face, negative ion spray at the same time acupoint massage along the meridian, apply 10min, clean the face with water, 3 times a week.

Intervention Type: DRUG

Other Intervention Names

Chinese Herbal Medicine; Chinese Herbal Medicine; Chinese Herbal Medicine; Chinese Herbal Medicine

Eligibility Criteria

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.

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.

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.

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Skin Disease and Venereal Disease Hospital

OTHER

Sponsor Role: collaborator

Shanghai Yueyang Integrated Medicine Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jia Zhou

Role: STUDY_CHAIR

Shanghai Yueyang Intergrated Medicnie Hospital,Shanghai

Central Contacts

Bin Li

Role: CONTACT

18930568129@163.com

0086-0021-55981301

Li Ju

Role: CONTACT

1090622414@qq.com

0086-0021-65161782

Other Identifiers

2020045

Identifier Type: -

Identifier Source: org_study_id