Investigating the effect of oral black seed oil capsules on the serum level of tenascin C biomarker in patients with knee osteoarthritis
Design
The clinical trial with a control and intervention group, will conducte in parallel and three-blind, randomized by simple randomization method using closed door envelope , and it will be phase 2-3 clinical trial study on 80 patients.
Settings and conduct
A study will be conducted on 80 patients with osteoarthritis of the knee referred to the rheumatology clinic of Qaim Hospital in Mashhad. which are placed in the intervention and control groups in a parallel three-way blind way (participant, evaluators and analysts). Oral black seed capsules in the intervention group and placebo in the control group will be consumed twice a day for 3 months, and the effect of this intervention on the tenascin-C serum level and the amount of pain in the knee area will be investigated.
Participants/Inclusion and exclusion criteria
The main condition for entering the study is knee osteoarthritis and Informed consent
Not suffering from primary inflammatory disease in the knee joint or arthritis caused by intra-articular tumor crystals
Not previous intra-articular fracture of the knee joint surgery (arthroscopic or otherwise) in the last 12 months
The absence of simultaneous severe diseases (metabolic diseases and history of stroke in the past)
Intervention groups
Intervention group: Patients will take two black seed capsules per day (every 12 hours) for 3 months, control group: patients will take two placebo capsules per day (every 12 hours) for 3 months; Medicine and placebo are prepared by Barij Essan Company, which are used along with the routine treatment of osteoarthritis which is the use of non-steroidal anti-inflammatory drugs in case of pain.
Main outcome variables
The amount of pain in the knee
Tenascin-C serum level
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210923052559N1
Registration date:2022-10-11, 1401/07/19
Registration timing:registered_while_recruiting
Last update:2022-10-11, 1401/07/19
Update count:0
Registration date
2022-10-11, 1401/07/19
Registrant information
Name
Farzaneh Iravani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3723 1750
Email address
farzaneh.baroon@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-23, 1401/07/01
Expected recruitment end date
2022-12-22, 1401/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of oral black seed oil capsule on serum level of Tenascin-C in knee osteoarthritis patients
Public title
The effect of oral black seed oil on knee osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Knee osteoarthritis
Satisfaction to enter the study
Exclusion criteria:
Taking medicine for osteoarthritis of the knee
Having an infection or primary inflammatory disease in the knee joint
Arthritis caused by crystals
Intra-articular tumors
Knee joint ligament instability
Previous intra-articular fracture
Knee joint surgery (arthroscopic or otherwise) in the last 12 months
Injection of any intra-articular drug in the last 3 months
Existence of simultaneous severe diseases (metabolic diseases and history of stroke in the past)
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization will be done by www.randomization.com website . Numbers will be placed in sealed envelopes and each envelope is assigned to one participant placing them in one of the two groups.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The study subjects and those who evaluate the outcome in the participants as well as the final analyst of the collected data of the study will be unaware of the intervention and control groups due to the fact that the placebo is used in the study in parallel with the drug.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2022-07-12, 1401/04/21
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1401.319
Health conditions studied
1
Description of health condition studied
Knee osteoarthritis
ICD-10 code
M19.9
ICD-10 code description
Osteoarthritis, unspecified site
Primary outcomes
1
Description
The amount of pain in the knee area
Timepoint
At the beginning of the study (before the start of the intervention) and 1, 2 and 3 months after the start of black seed oil capsules
Method of measurement
WOMAC questionnaire
2
Description
Tenascin-C serum level
Timepoint
At the beginning of the study (before the start of intervention) and 3 months after the start of taking black seed oil capsules
Method of measurement
ELISA method using the Tenascin-c kit from Zellbio GmbH company
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients in this group will take two black seed capsules per day (every 12 hours) for 3 months.Each capsule of black seed contains 5.3 mg of thymoquinone, the effective dose of which has anti-inflammatory effects and reduces the destruction of cartilage.The drug is prepared by Barij Essan Company.In addition to the routine treatment of osteoarthritis, which is the use of non-steroidal anti-inflammatory drugs in case of pain.
Category
Treatment - Drugs
2
Description
Control group: Patients in this group will take two placebo capsules (it will look similar to the medicine capsule) per day (every 12 hours) for 3 months.Placebo is also prepared by Barij Essan Company.In addition to the routine treatment of osteoarthritis, which is the use of non-steroidal anti-inflammatory drugs in case of pain.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem hospital
Full name of responsible person
Mandana Khodashahi
Street address
Ghaem hospital, Ahmad Abad Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3801 2649
Email
Khodashahim@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Majid Ghayour Mobarhan
Street address
Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 2081
Email
ramresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Mandana Khodashahi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Ghaem hospital, Ahmad Abad Ave.
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3801 2496
Email
Khodashahim@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mandana Khodashahi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Ghaem hospital, Ahmad Abad Ave.
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3801 2496
Email
Khodashahim@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mandana Khodashahi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Ghaem hospital, Ahmad Abad Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3801 2496
Email
Khodashahim@mums.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