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

Primary Purpose

Acne Vulgaris

Status

Unknown status

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

BaidI Quzhi granule

Ju Yin cream

Baidi Quzhi placebo granule

Ju Yin placebo cream

About this trial

This is an interventional treatment trial for Acne Vulgaris focused on measuring Acne Vulgaris, Randomized controlled trial, BaiDI QuZhi granule, Ju YIn cream, Traditional Chinese Medicine

Eligibility Criteria

16 Years - 45 Years (Child, Adult)All SexesDoes not accept 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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

TCM comprehensive treatment group

TCM internal treatment group

TCM external treatment group

Placebo group

Arm 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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Success rate of the investigators' overall assessment (IGA) for acne vulgaris

On the IGA (0-5) score, the percentage of subjects with IGA score reduction (baseline IGA- week 8 IGA) greater than or equal to 2 points.

Secondary Outcome Measures

skin lesion count (total, inflammatory and non-inflammatory)

The change level of the investigators' overall assessment(IGA) score

Visual analogue scale (VAS) score of facial itching symptoms

VAS are psychometric measuring instruments designed to document the characteristics of disease-related symptom severity in individiual patients and use this to achieve a rapid classification of symptom and disease control.

Visual analogue scale(VAS) score of facial pain symptoms

Skindex-16 scale

A brief Quality-of-Life measure for patients with the skin diseases

Traditional Chinese Medicine(TCM) syndrome score

Score TCM syndromes such as tongue, pulse and clinical manifestations

Interleukin(IL)-17

IL-17 was implicated in the pathogenic mechanisms of both inflammatory and infectious skin diseases such as staphylococcus infection, contact hypersensitivity, psoriasis and atopic dermatitis.

25-hydroxy Vitamin D

Vitamin D deficiency may have a role in the pathogenesis of acne

Dehydroepiandrosterone-sulfate(DHEA-S)

Adrenal steroid hormones produced by the secretion of the adrenal gland

Full Information

NCT ID

NCT05035979

First Posted

June 13, 2020

Last Updated

September 3, 2021

Sponsor

Shanghai Yueyang Integrated Medicine Hospital

Collaborators

Shanghai Skin Disease and Venereal Disease Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05035979

Brief Title

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

Official Title

Oral Baidi Quzhi Granule Combined With Ju Ying Cream for Acne Vulgaris: Protocol for a Randomized, Double-blind, Multicenter Clinical Trial

Study Type

Interventional

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Unknown status

Study Start Date

December 1, 2021 (Anticipated)

Primary Completion Date

July 1, 2023 (Anticipated)

Study Completion Date

August 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Shanghai Yueyang Integrated Medicine Hospital

Collaborators

Shanghai Skin Disease and Venereal Disease Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acne Vulgaris

Keywords

Acne Vulgaris, Randomized controlled trial, BaiDI QuZhi granule, Ju YIn cream, Traditional Chinese Medicine

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

472 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

TCM comprehensive treatment group

Arm Type

Experimental

Arm 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.

Arm Title

TCM internal treatment group

Arm Type

Active Comparator

Arm 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.

Arm Title

TCM external treatment group

Arm Type

Active Comparator

Arm 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.

Arm Title

Placebo group

Arm Type

Placebo Comparator

Arm 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.

Intervention Type

Drug

Intervention Name(s)

BaidI Quzhi granule

Other Intervention Name(s)

Chinese Herbal Medicine

Intervention Description

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

Intervention Name(s)

Ju Yin cream

Other Intervention Name(s)

Chinese Herbal Medicine

Intervention Description

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

Intervention Name(s)

Baidi Quzhi placebo granule

Other Intervention Name(s)

Chinese Herbal Medicine

Intervention Description

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

Intervention Name(s)

Ju Yin placebo cream

Other Intervention Name(s)

Chinese Herbal Medicine

Intervention Description

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.

Primary Outcome Measure Information:

Title

Success rate of the investigators' overall assessment (IGA) for acne vulgaris

Description

On the IGA (0-5) score, the percentage of subjects with IGA score reduction (baseline IGA- week 8 IGA) greater than or equal to 2 points.

Time Frame

up to 16th weeks

Secondary Outcome Measure Information:

Title

skin lesion count (total, inflammatory and non-inflammatory)

Description

The change level of the investigators' overall assessment(IGA) score

Time Frame