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IRCT20190107042264N1 IRCT 2019-03-05 Ahvaz University of Medical Sciences The Effect of Boswellia Serrata Extract on Osteoarthritis The Effect of a formulation containing Boswellia Serrata extract on the Osteoarthritis patients’ pain alleviation and quality of life improvement and comparison with Placebo and Piroxicam Gel 2019-02-20 anticipated 60 Complete https://irct.ir/trial/36984 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Using Research Randomizer(freely available at www.randomizer.org) sixty random numbers are generated. this unsorted series of numbers are then used to assign coded drugs to patients, Blinding description: Drugs and placebo produced in the faculty of pharmacy in addition to Piroxicam gel were given to an independent group for packing. all the material is then packed in completely similar tubes, containing a numbered code and instructions on how to use. these tubes are then given to the clinical team for assigning to the patients. The patient, the researcher and the clinical team are kept unaware of the contents of each tube. 3 Osteoarthritis. Intervention 1: Intervention group: Herbal Cream containing Boswellia Serrata Extract, Produced in Ahvaz Jundishapur University of Medical Sciences; 3 times a day for 4 weeks. Intervention 2: Control group: Placebo cream, Produced in Ahvaz Jundishapur University of Medical Sciences, 3 times a day for 4 weeks. Intervention 3: Control group: Piroxicam 0.5% Gel , Produced by Razak Laboratories Co., 3 times a day for 4 weeks. Yes - There is a plan to make this available What will be shared: Only a part of data will be published When: The data will be accessible until 6 months after the publication of the results To whom: The data will be available to researchers and scientists working in registered academic and scientific institutions Conditions: The obtained data will be available for further analysis Where to obtain: All interested parties should contact the corresponding author by e-mail How to obtain: after contacting the corresponding author, the data will be sent to Golestan hospital security for publication clearance, after the clearance, the data will be sent to the applicant Comments:
public Karim Mowla
Golestan Teaching Hospital - Farvardin St - Golestan
Ahvaz Iran (Islamic Republic of) 6135733118 +98 61 3374 3001 mowla-k@ajums.ac.ir Ahvaz University of Medical Sciences scientific Karim Mowla
Golestan Teaching Hospital - Farvardin St - Golestan
Ahvaz Iran (Islamic Republic of) 6135733118 +98 61 3374 3001 mowla-k@ajums.ac.ir Ahvaz University of Medical Sciences Iran (Islamic Republic of) Patient's presenting with knee pain with Osteoarthritis as a diagnosis at least three months since diagnosis Visual Analog Scale score must be more than 40 after stopping the treatment for 7 days Lequesne functional Index more than 7 after stopping the treatment for 7 days Patients must have the ability to stand and walk and to provide written and oral consent 18 years no limit Both Allergy of any kind to Boswellia and any of it's derivatives Malignancy Patient's unresponsive to conventional treatment Inflammatory Arthropathies Hyperuricemia Surgery planned New injury in sight of OA Intraarticular corticosteroid injection in the past 3 months Liver or Renal Failure History of gastric ulceration Uncontrolled Hypertension Congestive Heart Failure Pregnancy M17 Osteoarthritis of knee Rehabilitation Placebo Treatment - Drugs Intervention group: Herbal Cream containing Boswellia Serrata Extract, Produced in Ahvaz Jundishapur University of Medical Sciences; 3 times a day for 4 weeks Control group: Placebo cream, Produced in Ahvaz Jundishapur University of Medical Sciences, 3 times a day for 4 weeks Control group: Piroxicam 0.5% Gel , Produced by Razak Laboratories Co., 3 times a day for 4 weeks Stiffness of the Joint. Timepoint: The beginning of the study, 7, 14, 28 days after start of drug use. Method of measurement: The Western Ontario and McMaster Universities Osteoarthritis Index. Joint function. Timepoint: The beginning of the study, 7, 14, 28 days after start of drug use. Method of measurement: The Western Ontario and McMaster Universities Osteoarthritis Index; Lequesne Functional Index. Pain. Timepoint: The beginning of the study, 7, 14, 28 days after start of drug use. Method of measurement: The Western Ontario and McMaster Universities Osteoarthritis Index; Visual Analog Scale. Improvement in Quality of Life. Timepoint: The end of the study. Method of measurement: Summation and Analysis of The Western Ontario and McMaster Universities Osteoarthritis Index and Visual Analog Scale. Ahvaz University of Medical Sciences Approved 2019-01-19 Ethics committee of Ahvaz Jundishapur University of Medical Sciences Faculty of Medicine, Ahvaz Jundishapur University of Medical Sciences, Esfand Street, Golestan, Ahvaz, Iran Ahvaz Khouzestan Iran (Islamic Republic of)