The study is a double blind placebo control clinical trial on patients with knee osteoarthritis referred to a rheumatology clinic in sari. There are 40 patients in both group. After selecting the patients by inclusion and exclusion criteria, they will be divided to 2 subgroup according their VAS score (moderate: 4-7 and sever: 8-10) and will be given drug or placebo randomly. Before drug or placebo administration, knee radiography, serum creatinine, liver enzymes, ESR, blood pressure will be done.
Weight, height, and business will be recorded. Drug is the extract of Elaegnus Angustifolia and Zingiber that will be prescribed in 200 mg capsules. Placebo consisted of starch powder that will be put in the same capsules. Drug and placebo will be administrated 2 times per day for 2 monthes by a trained physician. In the end of study, we measure the drug effect by visual analogue scale, patient and physician global assessment, and drug usage for pain control in last week.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138812121828N3
Registration date:2010-04-24, 1389/02/04
Registration timing:prospective
Last update:
Update count:0
Registration date
2010-04-24, 1389/02/04
Registrant information
Name
Maryam Mobini
Name of organization / entity
Mazandaran University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 15 1324 4142
Email address
mmobini@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of research of Mazandaran University of medical sciences
Expected recruitment start date
2010-07-23, 1389/05/01
Expected recruitment end date
2011-02-20, 1389/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Elaegnus Angustifolia and Zingiber extract in pain and disability of patient with osteoarthitis
Public title
The effect of Elaegnus Angustifolia and Zingiber extract in pain and disability of patient with osteoarthitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1- Osteoarthritis,
2-Age between 50-60 years old,
3-moderate to sever pain,
4- agreement to participition.
Exclusion criteria:
1-other types of osteoarticular diseases,
2-uncontrolled hypertension,
3- heart failure(class 3 or 4),
4-chronic renal failure,
5- liver dysfunction,
6-peptic ulcers,
7-history of bronchospasm,
8- history of myocardial infarction or cerebrovascular accidents in last 12 months,
9- increased ES.
Age
From 50 years old to 60 years old
Gender
Both
Phase
2-3
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
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mazandarn university of medical sciences
Street address
Imam Khomeini Hospital, Sari
City
Sari
Postal code
Approval date
2010-04-03, 1389/01/14
Ethics committee reference number
88147
Health conditions studied
1
Description of health condition studied
Osteoarthritis
ICD-10 code
Arthrosis
ICD-10 code description
M15-M19
Primary outcomes
1
Description
Pain
Timepoint
2 months
Method of measurement
visual analogue scale, patient and physician global assessment the patient and drug usage for pain control in last week
Secondary outcomes
1
Description
Complications
Timepoint
2 month
Method of measurement
questionnaire
Intervention groups
1
Description
placebo
Category
Placebo
2
Description
Extract of Elaegnus Angustifolia and Zingiber (200 mg, 2 times per day for 2 monthes)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Rheumatology clinic in Tooba clinic
Full name of responsible person
Street address
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of research of Mazandaran University of medical sciences
Full name of responsible person
Dr Ahmad Ali Enayati
Street address
Deputy of research, Mazandaran university of medical sciences
City
Sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of research of Mazandaran 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
Mazandaran university of medical sciences
Full name of responsible person
Dr. Maryam Mobini
Position
Rheumatologist
Other areas of specialty/work
Street address
Imam Khomeiny hospital
City
Sari
Postal code
Phone
+98 15 1226 1700
Fax
Email
mmobini50@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of medical sciences
Full name of responsible person
Maryam Mobini
Position
Rheumatologist
Other areas of specialty/work
Street address
Deputy of research of Mazandaran University of medical sciences
City
Sari
Postal code
Phone
+98 15 1226 1700
Fax
Email
mmobini50@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Dr Maryam Mobini
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)