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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Acne Vulgaris

Intervention / Treatment
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* Drug: BaidI Quzhi granule
* Drug: Ju Yin cream
* Drug: Baidi Quzhi placebo granule
* Drug: Ju Yin placebo cream


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TCM comprehensive treatment group<br>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. | Drug: BaidI Quzhi granule<br>* 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.<br>* Other names: Chinese Herbal Medicine;Drug: Ju Yin cream<br>* 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.<br>* Other names: Chinese Herbal Medicine;|
| Active Comparator: TCM internal treatment group<br>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. | Drug: BaidI Quzhi granule<br>* 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.<br>* Other names: Chinese Herbal Medicine;Drug: Ju Yin placebo cream<br>* 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.<br>* Other names: Chinese Herbal Medicine;|
| Active Comparator: TCM external treatment group<br>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. | Drug: Ju Yin cream<br>* 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.<br>* Other names: Chinese Herbal Medicine;Drug: Baidi Quzhi placebo granule<br>* 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.<br>* Other names: Chinese Herbal Medicine;|
| Placebo Comparator: Placebo group<br>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. | Drug: Baidi Quzhi placebo granule<br>* 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.<br>* Other names: Chinese Herbal Medicine;Drug: Ju Yin placebo cream<br>* 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.<br>* Other names: Chinese Herbal Medicine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | up to 16th weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| skin lesion count (total, inflammatory and non-inflammatory) | The change level of the investigators' overall assessment(IGA) score | Patients will be evaluated at the 2st, 4nd, 6rd, 8th week and follow-up period (12th, 16th week). | 
| 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. | Patients will be evaluated at the 2st, 4nd, 6rd, 8th week and follow-up period (12th, 16th week). | 
| Visual analogue scale(VAS) score of facial pain 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. | Patients will be evaluated at the 2st, 4nd, 6rd, 8th week and follow-up period (12th, 16th week). | 
| Skindex-16 scale | A brief Quality-of-Life measure for patients with the skin diseases | Patients will be evaluated at the 2st, 4nd, 6rd, 8th week and follow-up period (12th, 16th week). | 
| Traditional Chinese Medicine(TCM) syndrome score | Score TCM syndromes such as tongue, pulse and clinical manifestations | Patients will be evaluated at the 2st, 4nd, 6rd, 8th week and follow-up period (12th, 16th week). | 
| 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. | Patients will be evaluated at Baseline and at the 8th week. | 
| 25-hydroxy Vitamin D | Vitamin D deficiency may have a role in the pathogenesis of acne | Patients will be evaluated at Baseline and at the 8th week. | 
| Dehydroepiandrosterone-sulfate(DHEA-S) | Adrenal steroid hormones produced by the secretion of the adrenal gland | Patients will be evaluated at Baseline and at the 8th week. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acne Vulgaris, Randomized controlled trial, BaiDI QuZhi granule, Ju YIn cream, Traditional Chinese Medicine