Investigating the effect of the Persian medicine product based on colchicum compared to placebo on pain and morning stiffness in patients with knee osteoarthritis: a triple-blind randomized clinical trial
Determining the effect of a traditional medicine product based on colchicum on the clinical symptoms of patients with knee osteoarthritis
Design
A placebo-controlled, parallel-group, triple-blind, randomized, phase 3 clinical trial on 70 patients. For randomization, patients are entered into the study by block randomization method in 35 blocks of size 2.
Settings and conduct
Patients referred to the rheumatology clinic of Rafsanjan University of Medical Sciences who are suffering from knee osteoarthritis and have the inclusion criteria are included in the study by block randomization method in 35 blocks of size 2. The researcher, the patients and the analyzer do not know the content of the packages and the study is triple blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients aged 45 to 70 years with a diagnosis of knee osteoarthritis and pain between 3.5 and 7.5 cm based on the visual analogue scale. Non-inclusion criteria: pregnancy or breastfeeding, history of systemic diseases such as heart or renal failure and uncontrolled blood pressure, Routine use of oral analgesic, Intra-articular injection of corticosteroid drugs during the last six months
Intervention groups
The intervention group consists of 35 patients receiving two capsules daily of the product including colchicum rhizome, ashwagandha rhizome and mastic gum.
The placebo control group includes 35 patients receiving two capsules of corn starch daily
Investigating the effect of the Persian medicine product based on colchicum compared to placebo on pain and morning stiffness in patients with knee osteoarthritis: a triple-blind randomized clinical trial
Public title
The effect of the Persian medicine product based on colchicum on knee osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 45-75 years old
Diagnosis of knee osteoarthritis based on the criteria of the American College of Rheumatology, which is confirmed by a rheumatology specialist.
The presence of moderate knee pain within 24 hours based on linear-visual pain scale (VAS) between 3.5 and 7.5 cm.
Completing the inform consent form
Exclusion criteria:
Pregnancy or breastfeeding
Lack of physical and mental ability to answer questions
Occurrence of debilitating disease during treatment
History of allergy to herbal medicines
use of alcohol or drug abuse
History of systemic diseases such as heart failure, kidney failure and uncontrolled blood pressure
Routine use of oral analgesic (except 500 mg oral acetaminophen daily)
Consuming nutritional and medicinal supplements on a regular and daily basis
Intra-articular injection of corticosteroid drugs during the last six months
Age
From 45 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are included in the study by block randomization in 35 blocks of size 2.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Capsules containing herbal medicine and placebo are placed completely similar packages after matching in terms of shape, smell and color and the packages are coded and provided to the researcher. The study is triple blind. Patients, researchers, and data analysts are blinded to capsule contents and codes. The person who codes the drugs has no role in patient selection and interpretation of results until the end of the study.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kerman University of Medical Sciences
Street address
Faculty of Persian medicine; Kerman university of medical sciences; Haft-Bagh highway
City
Kerman
Province
Kerman
Postal code
7616913555
Approval date
2023-05-01, 1402/02/11
Ethics committee reference number
IR.KMU.REC.1402.018
Health conditions studied
1
Description of health condition studied
Osteoarthritis
ICD-10 code
M17
ICD-10 code description
Osteoarthritis of knee
Primary outcomes
1
Description
Knee pain intensity
Timepoint
at the begining of intervention and 21 and 42 days after the intervention
Method of measurement
Western Ontario and McMaster Universities Arthritis Index (WOMAC) questionnaire, visual analogue scale (VAS) questionnaire
2
Description
morning stiffness of knee
Timepoint
at the begining of intervention and 21 and 42 days after the intervention
Method of measurement
Western Ontario and McMaster Universities Arthritis Index (WOMAC) questionnaire
3
Description
Physical performance
Timepoint
at the begining of intervention and 21 and 42 days after the intervention
Method of measurement
Western Ontario and McMaster Universities Arthritis Index (WOMAC) questionnaire
4
Description
Heel to thigh distance
Timepoint
at the begining of intervention and 21 and 42 days after the intervention
Method of measurement
Western Ontario and McMaster Universities Arthritis Index (WOMAC) questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 35 patients receiving capsules containing colchicum, ashwagandha and mustic gum twice a day for 42 days
Category
Treatment - Drugs
2
Description
Control group: 35 patients receiving capsules containing corn starch twice a day for 42 days
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Rheumatology clinic of Rafsanjan University of Medical Sciences
Full name of responsible person
Mitra Abbasifard
Street address
Ali ibn Abi Talib Hospital; Ali ibn Abi Talib Square
City
Rafsanjan
Province
Kerman
Postal code
7717937555
Phone
+98 34 3428 0185
Email
dr.mabbasifard@rums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Abedin Iranpour
Street address
Ebn-e-Sina St.,Jahad Blvd.,
City
Kerman
Province
Kerman
Postal code
7619813159
Phone
+98 34 3226 3719
Email
abediniranpour@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Hossein Karegar-Borzi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Faculty of Persian Medicine; Kerman University of Medical Sciences; Haft-Bagh highway
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3133 6185
Email
kbhossein@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Hossein Karegar-Borzi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Faculty of Persian Medicine; Kerman University of Medical Sciences; Haft-Bagh highway
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3133 6185
Email
kbhossein@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Mahboobeh Raeiszadeh
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Persian Medicine; Kerman University of Medical Sciences; Haft-Bagh highway
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 6167
Fax
Email
m.raeiszadeh@kmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available