Yunnan Baiyao Group Co., Ltd.
Conditions
Interventions
control group:Apply Yunnan Baiyao ointment to the painful area
experimental group:Apply Yunnan Baiyao ointment to the painful area
Sponsors
China-Japan Friendship Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 120 Years
Inclusion criteria
Inclusion criteria: 1: (1) 18 years old and above, regardless of gender; 2: (2) When screening, it meets the classification/diagnostic criteria for fibromyalgia syndrome published by the American College of Rheumatology in 2016 (see section 12.1): i. WPI = 7 and Symptom Severity Score (SSS) = 5; Or WPI=4-6 and SSS = 9 Ii. There must be widespread pain, with at least 4 out of 5 areas experiencing pain (excluding the lower jaw, chest, and abdomen) Iii. Diffuse symptoms persist for at least 3 months 3: (3) Not receiving non pharmacological or other pharmacological treatment for fibromyalgia, or dissatisfied with current treatment outcomes (VAS = 40mm during screening); 4: (4) Voluntarily agree to participate in this study and sign a written informed consent form.
Exclusion criteria
Exclusion criteria: 1: (1) Accompanied by infectious or inflammatory arthritis (such as rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis), systemic lupus erythematosus, untreated or active gout (i.e., any acute attacks within the past 2 years), or meeting the criteria for other types of systemic autoimmune diseases, with the disease being the primary source of pain; 2: (2) Complicated regional pain syndrome, failed back surgery syndrome, persistent or universal pain symptoms related to systemic diseases (such as diabetes peripheral neuropathy, post herpetic neuralgia), untreated hyperparathyroidism, or a history of previous surgery, trauma or other pain sources, which, in the judgment of the investigator, may confuse or interfere with the evaluation of fibromyalgia pain in patients; 3: (3) Merge serious systemic diseases, such as severe cardiovascular disease, malignant tumors, or immune suppression status; 4: (4) Combining epilepsy or neuropathic pain that requires anticonvulsant treatment; 5: (5) Combining a history of severe, controlled, or untreated sleep apnea, or having episodic sleep disorders, cataplexy, periodic limb movement disorders, or other clinically significant sleep disorders that are recorded; 6: (6) The planned administration site has active skin diseases, dermatitis, sunburn, unhealed wounds or severe scars; 7: (7) Known history of allergies or contact dermatitis to medical adhesives, transdermal patch excipients; Or those who are allergic to experimental drugs or their ingredients (such as Aconitum carmichaelii and Artemisia scoparia); 8: (8) Pregnant or lactating women, as well as women of childbearing age who are unable to take effective contraceptive measures evaluated by the researchers during the study period and within 28 days after discontinuing study treatment; 9: (9) History of severe mental disorders (such as schizophrenia, bipolar disorder, mental illness), or presence of severe, unstable, or uncontrolled mental conditions (such as borderline personality disorder, severe depressive episodes), or inability to communicate normally, resulting in poor treatment compliance as assessed by the researcher and inability to complete the study according to the research protocol; 10: (10) Frequent exposure to overheated environments (such as hot baths, saunas) or strong scrubbing of the planned administration area may affect patch adhesion or drug absorption; 11: (11) Due to work, exercise, or lifestyle habits, it is not possible to ensure stable adhesion of the patch to the planned area; 12: (12) Currently participating in other clinical trials; Or other investigational drugs or investigational devices cannot be eluted before screening; 13: (13) Other situations that the researchers believe are not suitable for participating in this experiment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| On the 29th day, there was a change in the Visual Analog Scale (VAS) for pain compared to baseline; | — |
Secondary
| Measure | Time frame |
|---|---|
| On the 15th, 29th, and 57th days, the revised Fibromyalgia Impact Questionnaire (FIQR) showed changes in scores compared to baseline;On the 29th day, the proportion of patients evaluated as clinically cured, significantly effective, or effective based on the change in FIQR score from baseline;Changes in VAS scores from baseline on the 15th and 57th days;On the 15th, 29th, and 57th days, the generalized pain index (WPI) in the fibromyalgia symptom questionnaire showed changes compared to baseline;On the 29th day, the proportion of patients evaluated as significantly effective or effective based on the change in VAS score from baseline;Changes in VAS scores of patients with different TCM syndrome differentiation types on the 28th day after treatment compared to baseline; | — |
Countries
China
Contacts
Public ContactFan Bifa
China-Japan Friendship Hospital
Outcome results
None listed