Rosacea
Conditions
Interventions
Treatment group:Kehuang capsules, 4 capsules/time, 3 times/day + Winona Hyaluronic Acid Repair Biomask
Control group:Kehuang placebo capsules, 4 capsules/time, 3 times/day + Winona Hyaluronic Acid Repair Biomask
Sponsors
The Second Affiliated Hospital of Hunan University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Meet the diagnostic criteria of rosacea; 2.Erythematotelangiectatic or papulopustular rosacea; 3.TCM syndrome differentiation were spleen-stomach damp-heat syndrome and/or liver stagnation and blood-heat syndrome; 4.Age >=18 years old and <= 65 years old, male or female; 5.Signed the informed consent voluntarily.
Exclusion criteria
Exclusion criteria: 1.Patients with severe primary diseases of cardiovascular, liver, kidney, brain, endocrine and hematopoietic systems (severe heart disease, cerebrovascular disease, uncontrolled diabetes, uncontrolled hypertension, abnormal liver and kidney function, dyslipidemia, or severely weakened immunity, etc.), malignant tumors, or intellectual or mental disorders; 2.Intermittent flushing or persistent erythema was caused by other factors, including topical drugs (glucocorticoids, tretinoin, etc.), systemic drugs (niacin, isotretinoin, etc.), local chemotherapy or phototherapy , menstrual or perimenopausal symptoms, and systemic diseases (carcinoid syndrome, systemic mastocytosis, medullary carcinoma of some glands, etc.); 3.Patients with other facial skin diseases other than acne vulgaris (solar dermatitis, contact dermatitis, etc.); 4.Patients with fundus lesions, or rosacea associated with phymatous nose; 5.Patients with depression (HAMD-17 score >= 18); 6.People with yang deficiency constitution (insufficient yang qi, mainly characterized by aversion to cold, cold hands and feet, etc.); 7.Patients who have previously used oral isotretinoin, antibiotics, steroids and other immune suppressants, systemic photochemotherapy, or the use of vasodilators or a-adrenergic receptor-blocking agents in the previous 4 weeks; 8.Pregnant or breastfeeding women, or those who have a pregnancy plan within 6 months; 9.People who are allergic to Kehuang capsules or Winona Hyaluronic Acid Repair Biomask, or with allergic constitution; 10.Patients who cannot guarantee the completion of medication and follow-up requirements during the clinical trial; 11.Patients who have participated in other clinical trials within 3 months; 12.Other conditions that the investigator considers ineligible to enroll.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical efficacy; | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical efficacy;Clinician’s Erythema Assessment;Patient’s Self-assessment;Flushing Symptoms Questionnaire;Investigator’s Global Assessment;Rosacea-specific Quality-of-Life;Patient Health Questionnaire-9;Generalized Anxiety Disorder-7; | — |
Countries
China
Contacts
Public ContactYang Zhibo
The Second Affiliated Hospital of Hunan University of Traditional Chinese Medicine
Outcome results
None listed