Clinical trial of Portulaca oleracea extract capsule on clinical indicators of osteoarthritis

The aim of this study is evaluated the effect of Portulaca oleracea extract capsule on clinical criteria of knee osteoarthritis.

Randomized double-blind, controlled clinical trial, parallel, phase 2-3 on 80 patients with moderate knee osteoarthritis (40 patients in each group) using computer randomization method.

A total of 80 patients, based on diagnostic criteria College of Rheumatology American and opinion specialty respectable knee, knee osteoarthritis diagnosed and other inclusion criteria are eligible. After learning about the research and consent, refer to the management team and then for each questionnaire, including demographic data, comorbidities, medications consumer, medical history and its complications will be completed. Then patients randomly into two groups A and B. using the parcel divided Group A Portulaca oleracea capsule three times a day, and Group B placebo capsule three times a day will use. Both common treatment involves taking pills of meloxicom before and during the study will receive. The study will be done in Mashhad University of Medical Sciences.

Inclusion criteria for this study include the following: Initial symptomatic osteoarthritis in at least one knee ; a score higher than 30 at baseline VAS scale; Obtain routine medical treatment (meloxicam tablets) for at least two weeks before the study; Exclusion criteria are as follows: The treatment with corticosteroids, hormonal drugs or hyaluronic acid before the start of the study

Intervention Group: Portulaca oleracea capsule three times a day, and routine treatment with meloxicam tablets Control group: Placebo capsule three times a day, and routine treatment with meloxicam tablets

Improvement of clinical symptoms of osteoarthritis (pain, Joint stiffness and physical performance)

In this study, we used Random Allocation software for randomization. The random sequence of samples was performed equally as Intervention and control groups using this software. For allocation concealment, sealed envelopes were used. In this method, each of the random sequences written on a card and is placed in the envelopes, respectively. Finally, the lid of the envelopes is glued and placed in a box, respectively. At the registration time, based on the order in which eligible participants enter the study, one of the envelopes of their choice will be opened and their assigned group will be revealed.

The capsules were packaged in the same shape and coded by an expert one in the research center using Random Allocation Software. Patients, and evaluators assess the outcome, are not aware of the contents of the package and grouping, and samples were delivered to patients randomly using Allocation concealment.