Oral Baidi Quzhi Granule Combined With Ju Ying Cream for Acne Vulgaris
1 other identifier
interventional
472
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Dec 2021
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 13, 2020
CompletedFirst Posted
Study publicly available on registry
September 5, 2021
CompletedStudy Start
First participant enrolled
December 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2023
CompletedSeptember 5, 2021
August 1, 2021
1.6 years
June 13, 2020
September 3, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (8)
skin lesion count (total, inflammatory and non-inflammatory)
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
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
Patients will be evaluated at the 2st, 4nd, 6rd, 8th week and follow-up period (12th, 16th week).
Skindex-16 scale
Patients will be evaluated at the 2st, 4nd, 6rd, 8th week and follow-up period (12th, 16th week).
Traditional Chinese Medicine(TCM) syndrome score
Patients will be evaluated at the 2st, 4nd, 6rd, 8th week and follow-up period (12th, 16th week).
- +3 more secondary outcomes
Study Arms (4)
TCM comprehensive treatment group
EXPERIMENTALParticipants 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.
TCM internal treatment group
ACTIVE COMPARATORParticipants 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.
TCM external treatment group
ACTIVE COMPARATORParticipants 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.
Placebo group
PLACEBO COMPARATORParticipants 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.
Interventions
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.
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.
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.
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.
Eligibility Criteria
You may qualify if:
- \- 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).
- \. 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.
You may not qualify if:
- \. Patients with severe primary diseases such as cerebrovascular, cardiovascular, liver, kidney and hematopoietic system.
- \. Participants will be ineligible if they ate pregnant or lactating women, and those with fertility plans in the next 2 years.
- \. Allergic constitution and allergic to the drug ingredients studied in this project.
- \. Cicatricial constitution. 6.Occupational acne caused by chemicals, acne caused by drugs.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jia Zhou
Shanghai Yueyang Intergrated Medicnie Hospital,Shanghai
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 13, 2020
First Posted
September 5, 2021
Study Start
December 1, 2021
Primary Completion
July 1, 2023
Study Completion
August 31, 2023
Last Updated
September 5, 2021
Record last verified: 2021-08