Evaluation Effect of Crocina on The Cellular Immune Responses in Osteoarthritis Patients
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|ClinicalTrials.gov Identifier: NCT03375814|
Recruitment Status : Active, not recruiting
First Posted : December 18, 2017
Last Update Posted : December 18, 2017
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis, Knee||Drug: Crocin Drug: Placebo Oral Tablet||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Crossover Assignment|
|Intervention Model Description:||Osteoarthritis patients who have age between 40 to 75 years old will be selected; Based on radiographic images of patients the severity of joints damage will get detailed and they will be placed in between grade 2 and grade 3 in terms of gradation; these patients will be not located underwent surgery; Patients will complete WOMAC and KOOS questionnaires to obtain some information such as following items; They will be no history of injury; they will not have diabetic disorders, rheumatism and kidney disease, osteonecrosis, gout; they will not have a long history anti-inflammatory drugs consumption; They will not have individuals with insufferable jobs carrying heavy loads; Patients will not have the Body Mass Index (BMI) of 30 or more|
|Official Title:||The Effect of Crocina on The Cellular Immune Responses in Patients With Osteoarthritis as Randomized, Double-blind and Placebo Controlled|
|Actual Study Start Date :||July 20, 2016|
|Estimated Primary Completion Date :||March 2, 2018|
|Estimated Study Completion Date :||July 30, 2018|
Experimental: Experimental group
The group that takes the main drug. They received the conventional treatment group and crocin.
This group (osteoarthritic patients) can receive crocin with conventional therapy
Other Name: Test group
Placebo Comparator: Placebo group
The group that takes the Placebo.
Drug: Placebo Oral Tablet
The group that takes Placebo Oral Tablet. They received the conventional treatment and Placebo Pills..
Other Name: Control group
- Radiographic report from knee [ Time Frame: 15 minute ]Patients suffering from osteoarthritis are classified in grades 1 to 4 and grades 2 and 3 will be enter to study.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03375814
|Iran, Islamic Republic of|
|Jaleh Shariati sarabi|
|Mashhad, Razavi Khorasan, Iran, Islamic Republic of|