Objective: To evaluate the effect of nanomicelle curcumin on the rate of improvement in symptoms of knee osteoarthritis patients
Design: A double-blind, block-randomized clinical trial.
Study population: Knee osteoarthritis patients referring to Imam Reza Hospital of Mashhad, Iran.
Inclusion criteria: Primary knee osteoarthritis with grade II and III base on Kellgren-Lawrence grading scale; having knee pain at least for six months; age between 45 and 65 years; and having primary osteoarthritis.
Exclusion criteria: Secondary osteoarthritis (due to trauma); knee arthroscopic surgery in less than six months; use of corticosteroids less than six months; history of allergy; use of medications affecting coagulation process (e.g., warfarin, heparin, clopidogrel, dipyridamole, and aspirin); genu varum, genu valgus, and pes planus patients; and patients with anserine bursitis.
Sample size: 80 cases.
Study intervention: The control group received 40 mg of placebo (similar components of curcumin capsules but without curcumin) and the intervention group was administered 40 mg of nanomicelle curcumin capsule every 12 hours for six weeks. Both participant and the researcher are blind to the medication because of the capsules are similar in packaging.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016100629884N1
Registration date:2017-04-11, 1396/01/22
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-04-11, 1396/01/22
Registrant information
Name
Najmeh Davoudian
Name of organization / entity
Mashhad University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 51 3882 2440
Email address
davoudiann931@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Mashhad University of Medical Sciences
Expected recruitment start date
2017-05-22, 1396/03/01
Expected recruitment end date
2017-11-20, 1396/08/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
To evaluate the effect of nanomicelle curcumin on the rate of improvement in symptoms of knee osteoarthritis patients
Public title
The effectiveness of curcumin on knee osteoarthritis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Primary knee osteoarthritis with grade II and III base on Kellgren-Lawrence grading scale; having knee pain at least for six months; age between 45 and 65 years; and having primary osteoarthritis.
Exclusion criteria: Secondary osteoarthritis (due to trauma); knee arthroscopic surgery in less than six months; use of corticosteroids less than six months; history of allergy; coagulation disorders and coronary heart disease; use of medications affecting coagulation process (e.g., warfarin, heparin, clopidogrel, dipyridamole, and aspirin); genu varum, genu valgus, and pes planus patients; and patients with anserine bursitis
Age
From 45 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Allocation to group is based on block-randomized. Both participant and the researcher are blind to the medication because of the capsules are similar in shape and packaging.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah Street
City
Mashhad
Postal code
91779-48564
Approval date
2016-08-03, 1395/05/13
Ethics committee reference number
IR.MUMS-fm.REC.1395.40
Health conditions studied
1
Description of health condition studied
Knee arthrosis
ICD-10 code
M17.0
ICD-10 code description
Primary gonarthrosis, bilateral
Primary outcomes
1
Description
Clinical outcomes including pain, stiffness, and physical function
Timepoint
Before and 6 weeks after intervention
Method of measurement
Western Ontario and Mcmaster Universities Osteoarthritis Index
Secondary outcomes
1
Description
Hepatic effects
Timepoint
After intervention
Method of measurement
Physical examination and levels of liver transaminases
Intervention groups
1
Description
The control group: Who are revising 40 mg of placebo (similar components of curcumin capsules but without curcumin) in 12 hours for 6 weeks
Category
Treatment - Drugs
2
Description
The intervention group: Who are revising 40 mg nanomicelle curcumin capsule in 12 hours for 6 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Zahra Mirfeizi
Street address
Emam Reza Hospital, Emam Reza Sq
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Mashhad University of Medical Sciences