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Pudilan Xiaoyan Oral Liquid in the Treatment of Moderate Acne Vulgaris (Damp heat syndrome of TCM) : A Multicenter, Randomized, Double-blind, Placebo- controlled Trial

Pudilan Xiaoyan Oral Liquid in the Treatment of Moderate Acne Vulgaris (Damp heat syndrome of TCM) : A Multicenter, Randomized, Double-blind, Placebo- controlled Trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200059107
Enrollment
Unknown
Registered
2022-04-25
Start date
2017-01-24
Completion date
Unknown
Last updated
2024-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Moderate Acne Vulgaris

Interventions

Experimental group:Pudilan Xiaoyan oral liquid combined with clindamycin gel
Control group:Placebo combined with clindamycin gel

Sponsors

Huashan Hospital of Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
16 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1. Aged 16-45 years, no gender limit. 2. The subject shall have: (1) Facial lesions, mainly inflammatory papules and pustules, with a total number of 31-100 lesions, including 0-2 nodules and 0 cysts; (2) The number of acne accounted for less than 10% of the total number of lesions including 10%. 3. TCM syndromes: (1) The subject's face is red and greasy, thirsty, and fond of drinking; (2) Bad breath, bitter mouth, rash itching and pain; Yellow urine, constipation; (3) The tongue is darker than the normal light red, the tongue coating is yellow and sticky, both the expression of smooth pulse, and the expression of several pulse; Must meet two or more of the above symptoms. 4. To sign an informed consent, the baseline pregnancy test results for female subjects of childbearing age must be negative.

Exclusion criteria

Exclusion criteria: 1. Patients who are lactating or have family planning; 2. Patients who have been allergic to traditional Chinese medicine or to this medicine or its ingredients; 3. Patients with serious primary diseases of endocrine, cardiovascular, cerebrovascular, liver, kidney and hematopoietic systems, mental patients or infections need systemic antibiotic treatment; 4. Acne caused by chemical substances, occupational acne, acne drug eruption; 5. Other skin diseases affecting the diagnosis, such as eczema, psoriasis, etc.; 6. Have received or be receiving any other investigational drug treatment in the 3 months prior to the trial; 7. The patients received retinoids within 6 months, antibiotics within 4 weeks, traditional Chinese medicine for clearing heat within 4 weeks, antibiotics and retinoids within 2 weeks before being enrolled in the study; 8. Poor cognitive ability, unable to complete the experiment according to the plan; 9. Alcohol abuse or history of drug abuse.

Design outcomes

Primary

MeasureTime frame
Acne Severity Score;

Secondary

MeasureTime frame
TCM Syndrome Score;

Countries

China

Contacts

Public ContactXu Jinhua

Huashan Hospital of Fudan University

xjhhsyy@163.com+86 13818978539

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026