Zushima Plaster for Treating Knee Osteoarthritis

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Status and phase: Completed; Phase 4

Conditions: Osteoarthritis

Treatments: Drug: Zushima plaster with high dose; Drug: Indometacin Cataplasms; Drug: Zushima plaster with low dose

Study type: Interventional

Funder types: Other

Identifiers

NCT02770950

81758

Details and patient eligibility

About

The purpose of this study is to further evaluate the clinical efficacy and safety of Zushima plaster for patients in knee osteoarthrosis post-marketing.

Enrollment: 396 patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Ages 40-75;
• Unilateral or bilateral knee OA, confirmed radiographically;
• Patients taking oral NSAIDs prior to the breakthrough period will be permitted;
• VAS pain score is or above 20mm.

Exclusion criteria

• Knee is swollen and hot;
• Allergic to any ingredient in Girald Daphne Bark Plaster (Girald Daphne Bark, Lithargite, Linseed oil, Red lead) ;
• Congestive Heart Failure and Edema;
• Advanced renal disease;
• Knee joint skin is burst or skin disease or allergies.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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396 participants in 3 patient groups

High dose group

Active Comparator group

Description:

High dose of Zushima plaster: a piece of Zushima plaster will be used topically for each knee for 24h per day. Eligible subjects will use a piece of Zushima plaster topically for each knee for 24h per day.

Treatment:

Drug: Zushima plaster with high dose

Low dose group

Active Comparator group

Description:

Low dose of Zushima plaster: a piece of Zushima plaster will be used topically for each knee for 12h per day. Eligible subjects will use a piece of Zushima plaster topically for each knee for 12h per day.

Treatment:

Drug: Zushima plaster with low dose

Controlled group

Active Comparator group

Description:

Indometacin Cataplasms will be used topically on the knee for 24h per day

Treatment:

Drug: Indometacin Cataplasms