Study on the effects of Tanacetum Parthenium (feverfew) on the symptoms of knee osteoarthritis: A randomized controlled clinical trial

Study of feverfew efficacy on knee osteoarthritis symptoms

This double-blind, phase 3 randomized clinical trial is performed on 64 knee osteoarthritis patients divided equally into parallel drug and placebo groups. Drug and placebo with code A or B are prescribed to patients for 2 months. Random numbers table is used for randomization.

ٍEligible Patients are randomly divided into two groups and administered drug or placebo with the identification code A or B for 2 months. At the start and after 2 months, the blood tests complete blood count, serum glutamic oxaloacetic transaminase, serum glutamic pyruvic transaminase, creatinine, blood urea nitrogen, prothrombin time and partial thromboplastin time are performed. Also, at the start and after 1 and 2 months, Western Ontario and McMaster Universities Arthritis Index questionnaire is completed for the patients. Patients are monitored for occurrence of drug side effects for 2 months. After 2 months, the patients are requested to determine their satisfaction with the treatment on a 10 centimeter ruler.

Eligible patients are those with definite diagnosis of knee osteoarthritis based on radiological criteria, ages 40-80 years, the ability to take oral drug, willingness and ability to cooperate with study follow-ups. Exclusion criteria are secondary osteoarthritis, knee surgery or injection history , severe systemic diseases, coagulopathies, anticoagulant use, lactation, pregnancy, pregnancy planning, and allergy to Asteraceae plants.

Drug group: Patients in this group take one 250 mg capsule of Tanacetum parthenium (feverfew) extract every 12 hours after meals for 2 months. Placebo group: Patients in this group take one 250 mg placebo capsule every 12 hours after meals for 2 months.

Total extent of knee osteoarthritis symptoms

Block randomization method using random blocks and random numbers table are employed.The patients are randomly divided into two groups A and B. One group receives the drug and the other group receives placebo. Sealed envelopes are used for concealment of allocation of the patients to the groups A and B. The patients numbers are written on the outsides of the envelopes and allocations to the groups A or B are written on the insides of the envelopes. Each patient selects one envelope.

Bottles of drug and placebo are labeled with the code B or A. Other specifications on the labels are identical. Physician, nurse, patients, data collectors and those who evaluate the outcomes are unaware of the drug and placebo groups. Patients are aware that they are either in the drug or placebo group, but they are not aware of the type of group they are in.

All data after de-identification can be shared.

Data are available one year after publication of the results for an infinite period of time.

Data and documents will be available only for people working in academic institutions.

No analysis on data or documents is permitted. Use of data and documents is permitted only with citation of the article in which they were published. The applicant for data or documents should mention the aim for access to data or documents.

Application for data or documents should be sent to Dr. Akram Rostamzadeh with the email rostamzadehak@yahoo.com

The applicant for data or documents should mention the reason and aim for the application. The application will be answered within at most 2 weeks.