The effects of curcuma, black pepper and ginger on prostaglandin E2 inflammatory marker and pain in patients with knee osteoarthritis in comparison with Naproxen
The population under study is affected with chronic knee osteoarthritis and a sample size of 60 patients who are randomly assigned using the numbers table. The study is double-blind that the patient and the analyst will not be aware of the type of intervention.
Inclusion criteria: knee idiopathic Osteoarthritis; the age range of 35-75 years; having knee pain with a score of more than 5 according to VAS criteria.
Exclusion criteria: having other knee diseases; osteoarthritis of hip or ankle joint; history of physiotherapy and intra-articular injection in the last 6 months; mental illness; neoplasmic tissues of the knee or bleeding;
Primary variables: Plasma prostaglandin-2 levels and pain score. Secondary variables: Weight, activity level. The sample size of the two groups is thirty, which will be given to a group of Mixodine extracts and another group of Naproxen drugs for four weeks. The dose for Mixodine is two capsules per day, and Naproxen is two tablets of 250 mg per day.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017070511763N32
Registration date:2017-10-22, 1396/07/30
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-10-22, 1396/07/30
Registrant information
Name
Gholamreza Askari
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1792 2110
Email address
askari@mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Isfahan University of Medical Sciences
Expected recruitment start date
2017-09-11, 1396/06/20
Expected recruitment end date
2017-10-12, 1396/07/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of curcuma, black pepper and ginger on prostaglandin E2 inflammatory marker and pain in patients with knee osteoarthritis in comparison with Naproxen
Public title
The effect's of curcuma, black pepper, ginger on inflammatory marker and pain in the patient with knee osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: knee idiopathic Osteoarthritis; in the age range of 35-75 years; walking ability; having knee pain with a score of more than 5 according to VAS criteria.
Exclusion criteria: having other knee diseases; infection of the hip joint and ankle osteoarthritis; radicular pain of lumbar spine disorders; history of physiotherapy and intra-articular injection in the last 6 months; mentall illness; neoplasmic tissues of the knee; infection and bleeding; neurological sensory and motor disorders; history of knee surgery; Obesity; consumption of aspirin and other non-steroidal anti-inflammatory drugs; pregnant women; drug use (such as opium)
Age
From 35 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Hezar Jarib Ave, Isfahan University of Medical Sciences
City
Isfahan
Postal code
Approval date
2017-08-23, 1396/06/01
Ethics committee reference number
IR.MUI.REC.1396.3.422
Health conditions studied
1
Description of health condition studied
Osteoarthritis knee
ICD-10 code
M17
ICD-10 code description
Gonarthrosis [arthrosis of knee]
Primary outcomes
1
Description
E2 prostaglandin plasma level
Timepoint
Before and after intervention
Method of measurement
Kit: Cat.No: ZB-11009S-H9648
2
Description
Pain score
Timepoint
Pre-intervention, first week, second week, third week, forth week
Method of measurement
Womac,vas questionnaire
Secondary outcomes
1
Description
The amount of energy you receive
Timepoint
Before the intervention,the fourth week
Method of measurement
Food recipes questionnaire
2
Description
Weight
Timepoint
Before intervention
Method of measurement
Digital scale
3
Description
Activists level
Timepoint
Before intervention
Method of measurement
Questionnaire
Intervention groups
1
Description
Intervention group: turmeric extract, black pepper, ginger
Myxodine capsule
Combination: 300 mg of curcumin, 5.7 mg of gingernol, 75.3 mg of piperin
Dosage: Two capsules per day
Time to use: Before meals
Duration: four weeks
Made in France Holistica Company
Category
Treatment - Drugs
2
Description
Control group: naproxen tablets
Dosage: Two 250 mg tablets
Usage time: morning and night
Duration: four weeks
Construction of Iran
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Musa Sadr clinic, Isfahan
Full name of responsible person
Dr. Gholamreza Askari
Street address
Mousavi crossroads, Foroughi Ave, Shohda Sq.
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Isfahan University of Medical Sciences
Full name of responsible person
Doctor Atar Movahdiean Ahmad
Street address
Isfahan University of Medical Sciences, Hezar Jarib Ave.
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Isfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Gorjiyan Pegah
Position
Master nutrition student
Other areas of specialty/work
Street address
School of Nutrition & Food Science, Hezar Jarib Ave,Isfahan
City
Isfahan
Postal code
Phone
+98 912 843 2119
Fax
Email
Pegahgorjiyan@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr.Gholamreza Askari
Position
Ph.D.Nutrition
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences, Hezar Jarib Ave, Isfahan
City
Isfahan
Postal code
Phone
+98 31 3792 3171
Fax
Email
Askari@mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
School of Nutrition & Food Science, Isfahan University of Medical Sciences
Full name of responsible person
Gorjiyan Pegah
Position
Master nutrition student
Other areas of specialty/work
Street address
School of Nutrition & Food Science, Isfahan University of Medical, Hezar Jarib Ave, Isfahan
City
Isfahan
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)