Effect of dried hydro alcoholic extract of pomegranate pericarp on oxidattive and inflammation state, Metaloproteinase 1, metabolic markers and clinical sign in women with knee osteoarthritis
This randomized double blind clinical trial was aimed to assess effects of dried hydro alcoholic extract of pomegranate pericarp on oxidattive and inflammation state, Metaloproteinase 1, metabolic markers and clinical sign in women with knee osteoarthritis disease severity from mild to moderate. Eighty 38-60 aged knee osteoarthritis patients within the Body Mass Index range of 30-35 kg/m2 will divide in to two control and intervention group. Intervention group will receive2* 500 mg dried hydro alcoholic extract of pomegranate pericarp while the control group will recive2 *500 mg placebo daily. Both of groups will receive standard drug therapy (2 tab acetaminophen 500,1 tab glocosamine) during two months of study. 3 day diet record, physical activity questionnaire will fill at beginning, middle and the end of study. Blood sampling, assessment of anthropometric measurements and biochemical indices (Oxidative and Inflammatory state, Metaloproteinase 1 and Lipid profile ) will take at the beginning and the end of study. All subjects will instruct to maintain their usual diet and physical activity throughout the study and not to consume any extra NSAIDs or analgesics .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201405183664N11
Registration date:2014-10-27, 1393/08/05
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-10-27, 1393/08/05
Registrant information
Name
Maryam Rafraf
Name of organization / entity
Tabriz University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 7580
Email address
rafrafm@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Tabriz University of Medical Sciences
Expected recruitment start date
2014-08-06, 1393/05/15
Expected recruitment end date
2014-12-06, 1393/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of dried hydro alcoholic extract of pomegranate pericarp on oxidattive and inflammation state, Metaloproteinase 1, metabolic markers and clinical sign in women with knee osteoarthritis
Public title
Effect of dried hydro alcoholic extract of pomegranate pericarp on oxidattive and inflammation state, Metaloproteinase 1, metabolic markers and clinical sign in women with knee osteoarthritis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
females aged 38-60 years-old؛
Primary bilateral knee osteoarthritis with mild to moderate severity based on American College of Rheumatology criteria؛
Body mass index within range of 30-35 kg/m2 ؛
Exclusion criteria :
Severe osteoarthritis( grade IV)؛
Secondary knee osteoarthritis based on ACR criteria؛
knee surgery or intra-articular injection؛
Neuromuscular diseases ؛
diabetes؛ cardiovascular disease؛ metabolic diseases؛ kidney and hepatic diseases؛
Smoking؛
Alcohol intake؛
Vitamin and Mineral,W3, W6 and other antioxidant supplement consumption one month before study and throughout the study؛
History of MI؛ History of peptic or duodenal ulcers؛
Allergy to pomegranate؛
Use of non-steroidal anti-inflammatory drugs(one week before study until the end of study)؛
30<BMI & BMI>35kg/m2 ؛
Age
From 38 years old to 60 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
no where
Secondary trial Id
0000
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of the Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, Daneshgah st.
City
Tabriz
Postal code
Approval date
2014-05-11, 1393/02/21
Ethics committee reference number
9328
Health conditions studied
1
Description of health condition studied
osteoarthritis
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
MDA
Timepoint
befor and the end of study
Method of measurement
mmol/l
2
Description
TAC
Timepoint
befor and the end of study
Method of measurement
mmol/l
3
Description
GPX,SOD
Timepoint
befor and the end of study
Method of measurement
unit/hemogloboline g
4
Description
MCP1, NFkB
Timepoint
befor and the end of study
Method of measurement
pg/ml
5
Description
hs-CRP
Timepoint
befor and the end of study
Method of measurement
mg/l
6
Description
MMP1
Timepoint
befor and the end of study
Method of measurement
pg/ml
7
Description
lipid profile
Timepoint
befor and the end of study
Method of measurement
mg/dl
8
Description
sistolic and diastolic BP
Timepoint
befor and the end of study
Method of measurement
mmHg
Secondary outcomes
1
Description
physical activity
Timepoint
befor,middle and the end of study
Method of measurement
qustionarie
2
Description
BMI
Timepoint
befor and the end of study
Method of measurement
kg/m2
3
Description
weight
Timepoint
befor and the end of study
Method of measurement
kg
4
Description
macro and micro nutrients
Timepoint
befor,middler and the end of study
Method of measurement
questionarie
Intervention groups
1
Description
intervention group: 500mg dried hydro alcoholic extract of pomegranate pericarp capsule twice a day
Category
Treatment - Drugs
2
Description
control group:500 mg placebo capsule ( starch )
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Dr Bina Eftekhar Sadat
Street address
Daneshgah st,next to faculty of dentistry
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Tabriz University of Medical Sciences
Full name of responsible person
Dr MR Rashidi
Street address
research vice chancellor of Tabriz University of Medical Sciences, Daneshgah St, Tabriz
City
Tabriz
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 of Tabriz 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
Nutrition faculty
Full name of responsible person
Mahdiyeh Khadem Haghighian
Position
PhD student of Nutrition
Other areas of specialty/work
Street address
Nutrition faculty, Tabriz University of Medical Sciences, Attar St, Tabriz
City
Tabriz
Postal code
Phone
+98 41 1386 3924
Fax
Email
mah_kh1362@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Nutrition faculty
Full name of responsible person
Mahdiyeh Khadem Haghighian
Position
PhD student of Nutrition
Other areas of specialty/work
Street address
Nutrition faculty, Tabriz University of Medical Sciences, Attar St, Tabriz
City
Tabriz
Postal code
Phone
+98 41 1386 3924
Fax
Email
mah_kh1362@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Nutrition Faculty
Full name of responsible person
Mahdiyeh Khadem Haghighian
Position
PhD student of Nutrition
Other areas of specialty/work
Street address
Faculty of Nutrition, Tabriz University of Medical Science, Attar St,Tabriz.
City
Tabriz
Postal code
Phone
+98 41 1386 3924
Fax
Email
mah_kh1362@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)