Comparison of the Effectiveness of Zingiber zerumbet ointment with Diclofenac Gel on clinical symptoms in patients with Knee osteoarthritis: A randomized, double-blind, controlled trial

Determine the effect of Zingiber Zerumbet (ZZ) ointment on the treatment of knee osteoarthritis

In this research, 80 eligible patients referring to Rheumatology Clinic of Mostafa Khomeini Hospital were chosen purposefully and a code was allocated to each one of them. Then, patients were randomly divided into two control and intervention groups, By block randomization method; For the drug group, ZZ ointment and acetaminophen is prescribed and for the positive control group diclofenac and acetaminophen.

80 patients with osteoarthritis accepted by the rheumatologist based on ACR classification criteria, After receiving written consent, they are randomly assigned to two groups of drugs and positive control. Drugs will be encoding, same shape and without the name, 1 grams, four times a day for 4 weeks will prescribe to intervention groups(Both groups). Patients are allowed to take acetaminophen if they have pain; Patients two weeks after the start and after 4 weeks of treatment (end of study) are examined by the rheumatologist and the relevant data through interviews and examination of them will be collected; And the WOMAC questionnaire is completed; Also, blood tests including CBC, BUN, Cr, AST, ALT, ALP, CRP , IL1 and IL6 are taken at the beginning of the test, and the tests are repeated at the end of the 4th week.

Inclusin criteria: Outpatient patients with knee osteoarthritis based on clinical criteria of ACR Exclusion criteria: Patients with Secondary osteoarthritis; Pregnancy; Joint Replacement; Knee corticosteroid injection in the past 3 months; Patients with active Renal and Liver Diseases.

In the intervention group, the ZZ ointment administered topically in the knee area 3 times a day for 4 weeks. In the positive control group, diclofenac gel was given topically in the knee area 3 times daily for 4 weeks.

Knee pain according to WOMAC questionnaire; The stiffness of the joint according to the WOMAC questionnaire; Limitations of physical activity based on WOMAC questionnaire

Immunology Research Center, University of shahed

The allocation of patients to Drug and Positive Control Groups, will be done by block randomization method. Zingiber Zerumbet (ZZ) Ointment and diclofenac gel are packed in completely similar containers and in weight; Each container is identified by a code. The code and contents of containers will be recorded by a third party in a sheet. The drugs are available to the researcher in the binary blocks of ZZ and diclofenac and ultimately distributed among the patients, the investigator and the patient are not aware of the contents of the packages.

The drug containers are encoded with the same shape and weight, and are given to the researcher in binary blocks, and then given to the patient; the patient, the investigator, and the analyst in the study are blinded; The medications, are indicated for the data analyst as drug A and drug B