Kashin-Beck disease
Conditions
Interventions
Control group:oral administration of etoricoxib tablets
Treatment Group 1:Monotherapy with oral diacerein capsules: Diacerein capsules (50 mg per capsule, 30 capsules per box
produced by Kunming Jida Pharmaceutical Co., Ltd.). For the first month, take 1 capsule once daily
from the second to the third month, take 1 capsule twice daily.
Treatment Group 2:Concurrent oral administration of Zhengqing Fengtongning Sustained-release Tablets and Diacerein Capsules. The dosage regimen is as follows: Zhengqing Fengtongning Sustained-release
Diacerein Capsules (50 mg per capsule, 30 capsules per box, manufactured by Kunming Jida Pharmaceutical Co., Ltd.), 1 capsule once daily for the first month, and 1 capsule twice daily from the second
Treatment Group 3:Oral administration of Zhengqing Fengtongning Sustained-release Tablets and Diacerein Capsules combined with dense silver needle acupuncture at the affected lesions. Zhengqing Fengto
manufactured by Hunan Zhengqing Pharmaceutical Group Co., Ltd.), with sinomenine hydrochloride as the principal active ingredient, were administered orally at a dosage of 1 tablet twice daily. Diacere
manufactured by Kunming Jida Pharmaceutical Co., Ltd.) were taken 1 capsule once daily during the first month, and 1 capsule twice daily from the second to the third month. Timing for dense silver nee
Sponsors
Shaanxi University of Traditional Chinese Medicine Second Affiliated Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Meet the diagnostic criteria for Kashin-Beck disease (KBD); 2.Clinical staging of illness severity at stage I or II; 3.Age range: 18–75 years old; 4.Stable disease condition; no oral or topical nonsteroidal anti-inflammatory drugs (NSAIDs), blood-activating and stasis-resolving Chinese patent medicines administered within the past two weeks, and no other targeted therapies for Kashin-Beck disease received during this period; 5.Voluntarily participate in this trial and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1.History of allergy to sinomenine and/or diacerein; 2.Received oral or topical nonsteroidal anti-inflammatory drugs (NSAIDs), blood-activating and stasis-resolving Chinese patent medicines, or other targeted therapies for Kashin-Beck Disease within two weeks prior to enrollment; 3.Complicated with severe systemic diseases including cardiovascular and cerebrovascular disorders, hepatic or renal insufficiency; 4.Suffering from severe mental disorders and unable to cooperate with follow-up visits; 5.Presenting coagulation dysfunction or severe hematological diseases; 6.Pregnant or lactating women; 7.Simultaneously participating in other clinical trials; 8.Any other conditions judged by the investigators to be inappropriate for trial participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Joint Dysfunction Assessment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Joint Pain Visual Analog Scale;Level of anxiety;Gastrointestinal Symptoms Grading and Scoring Scale;Quality of Life Rating;Serum inflammatory cytokine levels; | — |
Countries
China
Contacts
Public ContactKou Jiushè
Shaanxi University of Traditional Chinese Medicine Second Affiliated Hospital
Outcome results
None listed