Osteoarthritis is the most common joint disease.
(1) Objectives: This project is on the effect of ginger effective, safe and affordable in patients with osteoarthritis knee pain achieve
(2) Design: evaluation of the clinical trial is double blind.
(3) How to do: observing patients in the study, randomly selected. During the six month period, drug or placebo was given
(4) Participants and conditions of entry and exit: in part, was expressed.
(5) Interventions: prescription drug or placebo.
(6) The main outcome variables: Indices of pain (Visual Analog scale, Lequesne’s pain, and VOMAC), physical findings, patient and physician global assessment and possible side effects of drugs.
(7) Results: Severity of symptoms at each visit using the variables studied, were recorded. Patient information in the database were collected and analyzed. Detailed results with respect to drug and placebo when combined with other managing systems were used in these patients. Respect to detailed results; substantial and statistically significant effect on pain is seen in drug group that more prominent in first couple of weeks. Changes in physical examination results are given in detail in the text.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201111088034N1
Registration date:2012-12-03, 1391/09/13
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-12-03, 1391/09/13
Registrant information
Name
Ahmad Salimzadeh
Name of organization / entity
Tehran University of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6634 8500
Email address
salimzad@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of medical sciences, Vice chancellor for research
Expected recruitment start date
2004-04-20, 1383/02/01
Expected recruitment end date
2011-11-22, 1390/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Ginger extract on pain and physical examination finding in knee Osteoarthritis
Public title
Ginger effect on pain in knee osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria; knee pain and osteophyte in knee radiography; and at least one criterion of the three following criteria: 50 years age; Morning stiffness of less than 30 minutes; Crepitus in motion. Exclusion criteria: The history of rheumatoid arthritis, gout, chondrocalcinosis; severe and advanced cardiovascular disease class 4; proven malignancy; there is significant liver disease (esophageal varices and bleeding, encephalopathy, ascites); severe renal disease (creatinine greater than 3 mg dL); pregnancy and lactation; received intra-articular drug in former three months (or wait until this time period be spent); Glucosamine or Piascledine receive more than 2 weeks during the past six months; concomitant hip osteoarthritis
Age
From 50 years old to 80 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
140
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
Medical ethtics of Tehran University of medical sciences
Street address
Keshavarz Blvd
City
Tehran
Postal code
Approval date
2004-12-23, 1383/10/03
Ethics committee reference number
7559/132
Health conditions studied
1
Description of health condition studied
Knee osteoarthritis
ICD-10 code
M17.0
ICD-10 code description
Primary gonarthrosis, bilateral
Primary outcomes
1
Description
Knee pain
Timepoint
6 week
Method of measurement
VAS, Lequensnes Pain Index Of Severity For OA Of The Knee, VOMAC
Secondary outcomes
1
Description
Joint crepitus
Timepoint
6 month
Method of measurement
physical exam
2
Description
Patient global assessment
Timepoint
Each 6 weeks
Method of measurement
Interview
3
Description
Physician global assessment
Timepoint
Each 6 weeks
Method of measurement
Questionnaire
4
Description
Drug side effect
Timepoint
Each 6 weeks
Method of measurement
Interview
Intervention groups
1
Description
The drug is extracted from ginger and packed as gelatinous capsule. Each capsule contains 1 gram of ginger extract that equal to 3 gram of crude plant. The patient must be taken 3 capsules by meal in divided dose.
Category
Treatment - Drugs
2
Description
The placebo is made from same capsule but is filled by starch.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Dr Ahmad Salimzadeh
Street address
Emam Khomeini Ave.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of medical sciences, Vice chancellor for research
Full name of responsible person
Dr Akbar Fotoohi
Street address
Keshavarz Blvd.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of medical sciences, Vice chancellor for research
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
Tehran University of medical sciences, Sina Hospital
Full name of responsible person
Dr Ahmad Salimzadeh
Position
Associate professor
Other areas of specialty/work
Street address
Emam Khomeini Ave.
City
Tehran
Postal code
Phone
+98 21 6634 8500
Fax
Email
salimzad@tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of medical sciences, Sina Hospital
Full name of responsible person
Dr Ahmad Salimzadeh
Position
Associate professor
Other areas of specialty/work
Street address
Emam Khomeini Ave.
City
Tehran
Postal code
Phone
+98 21 6634 8500
Fax
Email
salimzad@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of medical sciences, Sina Hospital
Full name of responsible person
Dr Ahmad Salimzadeh
Position
Associate professor
Other areas of specialty/work
Street address
Emam Khomeini Ave.
City
Tehran
Postal code
Phone
+98 21 6634 8500
Fax
Email
salimzad@tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)