The comparison of the effect of Harpagophytum and Curcuma and diclofenac sodium on pain, stiffness and physical function of knee in elderly patients with osteoarthritis
Evaluation and comparison of the effect of Harpagophytum and Curcuma and diclofenac sodium on pain, stiffness and physical function of knee in elderly patients with osteoarthritis
Design
Randomly using the hexagonal permutation blocks method
Double blinded trial
Medications are taken orally twice daily during the morning when you wake up and at night when you are asleep for 30 days.
Also, in 5 steps at the beginning of the experiment and at one week to one month intervals, the Woemek instrument questionnaire of pain, joint stiffness and knee function was recorded.
Settings and conduct
Traditional medicine center of Sabzevar University of Medical Sciences
Participants/Inclusion and exclusion criteria
Elderly men and women 60 years and over - Knee pain more than two months - Joint stiffness less than 30 minutes morning - Swelling on knee examination - Knee osteoarthritis diagnosed by radiographic evidence - No history of surgery related to the disease (eg replacement and joint repair) On the knee - Acceptable cognitive ability based on a brief cognitive test tool (score of 7 and above) - Ability to communicate and adhere to medication regimen - Injection of the drug into the knee joint within 30 days prior Intervention or program for injection until the end of the study period - Absence of heart disease - Absence of history of gastric ulcer
Intervention groups
Three intervention groups, group one devil's claw (Christine 480 million g tenthal), group two 80 ml sinaccuramine capsule and group three diclofenac sodium 25 guest 2 daily draw.
Main outcome variables
pain, stiffness and physical function of knee
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200107046033N1
Registration date:2020-02-23, 1398/12/04
Registration timing:prospective
Last update:2020-02-23, 1398/12/04
Update count:0
Registration date
2020-02-23, 1398/12/04
Registrant information
Name
Raha Salehabadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4465 7265
Email address
rahasalehabadi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-03, 1399/01/15
Expected recruitment end date
2020-09-05, 1399/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of the effect of Harpagophytum and Curcuma and diclofenac sodium on pain, stiffness and physical function of knee in elderly patients with osteoarthritis
Public title
effect of Harpagophytum and Curcuma and diclofenac sodium in elderly patients with osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Knee osteoarthritis diagnosed by radiographic evidence and medical expert
Knee pain more than two months
Acceptable cognitive ability based on a brief cognitive test tool (score of 7 and above)
No history of surgery related to the disease (eg replacement and joint repair)
Non-injection of the drug into the knee joint within 30 days prior to intervention or schedule for injection until the end Study period
Exclusion criteria:
Taking narcotic drugs
History of gallbladder and liver disease
any surgery in the next 2 weeks
Blindness and deafness and inability to communicate
severe and untreated diseases
Use of psychotropic drugs
Age
From 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Individuals who were eligible for the study were randomly assigned to the six-group permutation blog (blocks are multiples of the number of groups) with 6 individuals divided into three groups. Random number tables are used to select the number of blocks. (Permuted block randomization (6 parts)
Blinding (investigator's opinion)
Double blinded
Blinding description
Participant blindness: The drugs in the study are placed in identical containers and provided by the researcher with the help of the participant.
Researcher blindness: Benefiting from researcher assistance
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Sabzevar University of Medical Sciences
Street address
Hemmat5- Adib2- niyayesh
City
Sabzevar
Province
Razavi Khorasan
Postal code
9618755736
Approval date
2020-01-04, 1398/10/14
Ethics committee reference number
IR.MEDSAB.REC.1398.078
Health conditions studied
1
Description of health condition studied
osteoarthritis
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pain, stiffness and knee joint function based on the WOMAC questionnaire
Timepoint
In 5 steps at the beginning of the experiment and at intervals of one week to one month
Method of measurement
WOMAC questionnaire
Secondary outcomes
1
Description
pain reduction
Timepoint
5 times: 1 before intervention and 4 times after intervention with weekly intervals for 4 weeks
Method of measurement
WOMAC questionnaire
Intervention groups
1
Description
Intervention group 1: 40 mg curcumin tablet administered by Exir Nano Sina Pharmaceutical Company once daily.
Category
Treatment - Drugs
2
Description
Intervention group 2: Talental 480 mg tablet administered by Razak Pharmaceutical Company twice daily.
Category
Treatment - Drugs
3
Description
Intervention group III: 25mg sodium diclofenac tablet administered by Razak Pharmaceutical Company twice daily.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Traditional medicine center .Sabzevar University of Medical Sciences
Full name of responsible person
Fereshte Ghorat
Street address
Asadabadi- Traditional medicine center .Sabzevar University of Medical Sciences
City
Sabzevar
Province
Razavi Khorasan
Postal code
9618755736
Phone
+98 51 4401 8000
Email
rahasalehabadi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Fereshte Ghorat)Vice-chancellor in Research and Technology, Sabzevar University of Medical Sciences)
Street address
Vice-chancellor in Research and Technology, Sabzevar University of Medical Sciences, Sabzevar, POBox 319, Iran
City
sabzevar
Province
Razavi Khorasan
Postal code
9618755736
Phone
+98 51 4401 8319
Email
ghorat@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Bojnord University of Medical Sciences
Proportion provided by this source
14
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
Sabzevar University of Medical Sciences
Full name of responsible person
Raha Salehabadi
Position
faculty member
Latest degree
Master
Other areas of specialty/work
Geriatric
Street address
Sabzevar university of medical sciences
City
savzevar
Province
Razavi Khorasan
Postal code
9618755736
Phone
+98 51 4401 8314
Email
rahasalehabadi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Fereshte Ghorat
Position
faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Vice-chancellor in Research and Technology, Sabzevar University of Medical Sciences, Sabzevar, POBox 319, Iran
City
Sabzevar
Province
Razavi Khorasan
Postal code
9618755736
Phone
+98 51 4401 8319
Email
ghorat@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Raha Salehabadi
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Geriatrics
Street address
Sabzevar university of medical sciences
City
Sabzevar
Province
Razavi Khorasan
Postal code
9618755736
Phone
+98 51 4401 8314
Email
rahasalehabadi@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
Not applicable
Title and more details about the data/document
Information about the results of the study can be published.
When the data will become available and for how long
Data Access: Six months after the article was published
To whom data/document is available
Researchers working in academic and scientific institutions
Industry practitioners
Traditional medicine centers
Under which criteria data/document could be used
Researchers can provide their clients with a range of seniority and therapies as written research requests with the consent of their international company.
From where data/document is obtainable
After obtaining the written consent of the research team, it is possible to refer or correspond to the Vice President of Research and Technology of Sabzevar University of Medical Sciences.
What processes are involved for a request to access data/document
After obtaining the written consent of the research team, it is possible to refer or correspond to the Vice President of Research and Technology of Sabzevar University of Medical Sciences.