acne vulgaris
Conditions
Interventions
placebo control:Subjects who meet the selection criteria will be randomly assigned to the control group, which will receive a simulated dose of Niuhuang Shangqing Capsules. Oral administration of Niuh
Experimental group:Subjects who meet the selection criteria are randomly assigned to the experimental group, which takes Niuhuang Shangqing capsules. Niuhuang Shangqing Capsules are taken orally, taki
Sponsors
Beijing Traditional Chinese Medicine Hospital Affiliated to Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: (1) Age range from 18 to 45 years old, regardless of gender; (2) The baseline investigator's overall assessment (IGA) is level 2 (mild, more severe than level 1; there are some non inflammatory skin lesions with only a few inflammatory skin lesions (only papules/pustules, no nodular skin lesions) or level 3 (moderate, more severe than level 2; there are more non inflammatory skin lesions, and there may be some inflammatory skin lesions, but no more than one small nodular skin lesion); (3) According to the Pillsbury International Modified Classification, patients clinically diagnosed with acne vulgaris grade II (with acne, moderate papules and pustules, total lesions between 31-50) or grade III (with numerous papules and pustules, occasional large inflammatory lesions, widely distributed, total lesions between 51-100, nodules/cysts<3); (4) The lung meridian wind heat syndrome that meets the diagnostic criteria of traditional Chinese medicine (main symptoms: skin lesions are mainly red or skin colored papules, acne, or itching and pain. Secondary symptoms: constipation, short and red urine, thirsty and fond of drinking; tongue and pulse: sharp red tongue edge, thin and yellow coating, floating pulse or pulse number. Those with two or more main symptoms and secondary symptoms can be diagnosed as lung meridian wind heat syndrome) or spleen and stomach damp heat syndrome (main symptoms: skin lesions are mainly red papules and pustules, with pain, greasy skin on the face, chest, and back. Secondary symptoms: may be accompanied by bad breath, bitter taste, numbness, loose stools or sticky discomfort. Constipation, yellow urine; red tongue and greasy coating, smooth or stringy pulse. Patients with two or more main and secondary symptoms can be diagnosed as spleen and stomach damp heat syndrome) acne vulgaris patients; (5) Voluntarily participating in clinical trials and signing informed consent forms, able to consciously abide by the trial protocol, adhere to medication, receive timely follow-up visits, and have good compliance.
Exclusion criteria
Exclusion criteria: (1) Individuals with eruptive acne, aggregative acne, drug-induced acne (including corticosteroids, neuropsychiatric drugs, anti tuberculosis drugs, immunomodulators, small molecule targeted drugs, etc.), occupational acne, and other special types of acne; (2) Acne patients who require anti androgen treatment (including estrogen, progesterone, spironolactone, and insulin sensitizers, etc.), or patients with Chongren syndrome who meet the diagnostic criteria of traditional Chinese medicine syndrome; (3) Facial complications with other skin diseases that may affect the efficacy and safety evaluation, such as sunburn dermatitis, hormone dependent dermatitis, rosacea, psoriasis, eczema, seborrheic dermatitis, etc; (4) Individuals with localized enteritis or inflammatory bowel disease (such as ulcerative colitis, pseudomembranous colitis, chronic diarrhea, or antibiotic related colitis, bloody diarrhea, etc.) or a history of related illnesses during screening; (5) Female patients with a history of polycystic ovary syndrome (PCOS); (6) Within 2 weeks prior to the first medication, topical topical treatments such as benzoyl peroxide, antibiotics (such as erythromycin, lincomycin, clindamycin, chloramphenicol, fusidic acid, and mospirocin), azelaic acid, sulfur, salicylic acid, and traditional Chinese medicine were used to treat acne on the face; (7) Individuals who have been treated with topical retinoids (including tazarotene, adapalene, retinoic acid, isotretinoic acid, etc.) on the face within 4 weeks prior to the first medication, or who have undergone physical and chemical therapies such as phototherapy, grinding, or chemical exfoliation to treat acne; (8) Individuals who have used systemic anti acne treatments such as antibiotics and corticosteroids within 4 weeks prior to their first medication; (9) Individuals who have used systemic anti acne treatment with retinoids within 12 weeks prior to their first medication; (10) Systemic traditional Chinese medicine preparations that have been determined by researchers to have an impact on acne vulgaris have been used within 4 weeks prior to the first medication; (11) Individuals who suffer from malignant tumors, as well as serious primary diseases such as cardiovascular, cerebrovascular, respiratory, endocrine, metabolic, rheumatic, immune, and hematological systems, or mental illnesses that the researcher deems unsuitable to participate in this clinical trial; (12) Severe liver and kidney diseases, with serum AST and ALT exceeding 2 times the upper limit of the normal range, or Cr exceeding 1.5 times the upper limit of the normal range; (13) Individuals who are known to be allergic to any component of the investigational drug, or have an allergic constitution and have been assessed by the researcher as unsuitable to participate in this trial; (14) Pregnant and lactating women; (15) Women who have engaged in unprotected sexual activity within 2 weeks prior to the first administration of medication; (16) Individuals who have a fertility plan from 2 weeks before the first administration to the end of the study and are unwilling to use effective physical contraception measures (such as condoms, intrauterine devices, contraceptive rings, ligatures, abstinence, etc., not included in the safe period contraception method) for contraception (including the subject's partner), or those who plan to donate sperm and eggs; (17) Those who are currently participating in other clinical trials or have particip
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| At the end of treatment (day 28), the percentage change in total skin lesion count from baseline for each group of subjects; | — |
Secondary
| Measure | Time frame |
|---|---|
| The percentage change in total skin lesion count from baseline for each group of subjects until the 14th day of treatment;Changes in inflammatory skin lesion count, non inflammatory skin lesion count, and total skin lesion count from baseline in each group of subjects until the 14th and 28th day of treatment;Ratio of subjects with IGA scores of 0 (cleared) and 1 (mild) in each group at day 14 and 28 of treatment;At the 14th and 28th day of treatment, the TCM skin lesion symptoms (type, quantity, color, itching, pain, etc.) of each group were scored, and the TCM skin lesion symptom efficacy index and total effective rate were calculated;At the 14th and 28th day of treatment, the TCM syndrome scores of each group were evaluated, and the TCM syndrome efficacy index and total effective rate were calculated;At the 14th and 28th day of treatment, the DLQI scores for skin diseases in each group were evaluated;At the 28th day of treatment, IL-1 and TNF- a Changes in detection values compared to baseline values; | — |
Countries
China
Contacts
Public ContactZhou Dongmei
Beijing Traditional Chinese Medicine Hospital Affiliated to Capital Medical University
Outcome results
None listed