Determination of the efficacy of oral chickpeas on the clinical symptoms of patients with knee osteoarthritis
Design
Non randomized non controlled clinical trial, phase 2. The sample size is 45 patients. The enrolled patients will follow up for one month.
Settings and conduct
This study is done in Imam Khomeini Hospital of Falavarjan, and the type of this study is before-after. Blinding does not occur in this study.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: 1. Positive history of rheumatoid arthritis disease; 2. Positive history of goat disease; 3. Positive history of Calcium Pyrophosphate Deposition Disease 4. Being afflicted with uncontrolled cardiovascular disease; 5. Being afflicted with proven malignancies Creatinine level is greater than 3 mg /dl 6. Receiving oral corticosteroids during 4 weeks ago 7. Receiving nonsteroidal anti-inflammatory (NSAIDs) drugs at the doses greater than 50 mg daily (except aspirin); 8. Receiving acetaminophen at the doses greater than 650 mg daily; 9. Receiving intra-articular medications during three months ago; 10. Unwillingness or inability of the patient to answer the questions of the questionnaire used in the study. Exclusion criteria: 1.Patients in the rage of 40 to 80 years old 2.The (American College of Rheumatology) ACR clinical criteria for knee osteoarthritis were fulfilled 3.Patients with knee osteoarthritis in grades of 1, 2, and 3
Intervention groups
Intervention group: Patients with knee osteoarthritis receiving chickpeas with the dosage of a cup of chickpeas for lunch and dinner meals in the days of 1 to 5 of treatment period, then continue to eat chickpeas for two meals per week until fourth week of treatment
Main outcome variables
Pain, activities of daily living, sport and recreation function, and knee-related quality of life in patients with knee osteoarthritis.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150825023753N12
Registration date:2019-07-20, 1398/04/29
Registration timing:retrospective
Last update:2019-07-20, 1398/04/29
Update count:0
Registration date
2019-07-20, 1398/04/29
Registrant information
Name
Mohammad Mahdi Parvizi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3212 5592
Email address
parvizim@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-04-09, 1396/01/20
Expected recruitment end date
2018-06-20, 1397/03/30
Actual recruitment start date
2017-04-21, 1396/02/01
Actual recruitment end date
2019-01-20, 1397/10/30
Trial completion date
2019-02-19, 1397/11/30
Scientific title
The efficacy of chickpeas diet on clinical symptoms of patients with osteoarthritis of the knee
Public title
The efficacy of chickpeas diet on clinical symptoms of osteoarthritis of the knee
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients in the rage of 40 to 80 years old
The American College of Rheumatology (ACR) clinical criteria for knee osteoarthritis were fulfilled
Patients with osteoarthritis of the knee grades 1, 2, and 3
Exclusion criteria:
Positive history of rheumatoid arthritis disease
Positive history of goat disease
Positive history of Calcium Pyrophosphate Deposition Disease
Being afflicted with uncontrolled cardiovascular disease
Being afflicted with proven malignancies
Creatinine level is greater than 3 mg /dl
Receiving oral corticosteroids during 4 weeks ago
Receiving nonsteroidal anti-inflammatory (NSAIDs) drugs at the doses greater than 50 mg daily (except the aspirin)
Receiving acetaminophen at the dosage of greater than 650 mg daily
Receiving intra-articular medications during three months ago
Unwillingness or inability of the patient to answer the questions of the questionnaire used in the study
Age
From 40 years old to 80 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
45
Actual sample size reached:
45
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee on Biomedical Research of Shahid Beheshti University of Medical sciences
Street address
Shahid Beheshti University of Medical sciences, Daneshju Blv
City
Tehran
Province
Tehran
Postal code
1983963113
Approval date
2017-01-09, 1395/10/20
Ethics committee reference number
IR.SBMU.RETECH.REC.1395.628
Health conditions studied
1
Description of health condition studied
Osteoarthritis of knee
ICD-10 code
M17
ICD-10 code description
Osteoarthritis of knee
Primary outcomes
1
Description
knee pain
Timepoint
One month
Method of measurement
Questionnaire of knee Injury and Osteoarthritis Outcome Score (KOOS questionnaire)
2
Description
Knee function
Timepoint
One month
Method of measurement
Questionnaire of knee Injury and Osteoarthritis Outcome Score (KOOS questionnaire)
3
Description
Sport and Recreation Function
Timepoint
One month
Method of measurement
Questionnaire of knee Injury and Osteoarthritis Outcome Score (KOOS questionnaire)
4
Description
Activities of daily living,
Timepoint
One month
Method of measurement
Questionnaire of knee Injury and Osteoarthritis Outcome Score (KOOS questionnaire)
5
Description
Knee-related quality of life
Timepoint
One month
Method of measurement
Questionnaire of knee Injury and Osteoarthritis Outcome Score (KOOS questionnaire)
Secondary outcomes
1
Description
Patient satisfaction from treatment
Timepoint
One month
Method of measurement
Global patient assessment questionnaire
Intervention groups
1
Description
Intervention group: Administrating a cup of chickpeas for lunch and dinner meals in the first five days of treatment, and then continuing to eat chickpeas for two meals per week to fourth week of treatment
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital of Falavarjan
Full name of responsible person
Dr Roshanak Mokaberinejad
Street address
Isfahan Province, Falavarjan, Kamarbandi Jonobi
City
Falavarjan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3743 5083
Email
mokaberi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Roshanak Mokaberinegad
Street address
No.8 Shams Alley, Opposite Tavanir St, Vali Asr St, Tehran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8877 2521
Email
mokaberi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Neda Ahmadi
Position
PhD student of traditional Persian medicine
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
No.8 Shams Alley, Opposite Tavanir St, Vali Asr St, Tehran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8877 2521
Email
drahmadi95@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Roshanak Mokaberinegad
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
No.8 Shams Alley, Opposite Tavanir St, Vali Asr St, Tehran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8877 2521
Email
mokaberi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Mahdi Parvizi
Position
Assisstant professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Zand Ave, Shahid Faghihi Hospital,
City
Shiraz
Province
Fars
Postal code
7134846114
Phone
+98 71 3212 5592
Email
mmparvizi@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Demographic data and the result of the clinical trial
When the data will become available and for how long
6 month later
To whom data/document is available
Researchers
Under which criteria data/document could be used
After publication of the extracted article of the clinical trial
From where data/document is obtainable
Sending Email to the researchers
What processes are involved for a request to access data/document