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The Joint Effects of Turmeric, Black Seeds, Flaxseed and Medicago Sativa for relieving symptoms of knee osteoarthritis: A Phase 1-2 Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Protocol summary

Study aim
Efficacy and safety of Turmeric, Black Seeds, Flaxseed, and Medicago Sativa in patients with osteoarthritis
Design
A Phase 1-2 Randomized, Double-Blind, Placebo-Controlled Clinical Trial. Using balanced block randomization, patients will be enrolled in one of the two groups
Settings and conduct
This study will be conducted in hospitals affiliated with Tabriz University of Medical Sciences. Adults >40 years who have had osteoarthritis for at least 6 months and whose osteoarthritis diagnosis meets the American College of Rheumatology criteria will be eligible. Patients will be instructed to apply the ointment topically three times daily (9 AM, 3 PM, and 9 PM), for up to 12 weeks. Efficacy and safety evaluations of ointments will be done in clinic visits on days 30, 60, and 90 (final visit). Patients will receive boxes with sealed 10-digit codes and will not be aware of the type of judgment received. Doctors, researchers, and those in charge of implementing the project will not know the type of medicine the patients received until the end of the study.
Participants/Inclusion and exclusion criteria
Adults over 40 years of age who have had OA for at least 6 months, and whose OA diagnosis meets the American College of Rheumatology criteria, will be eligible to participate in the present study. Patients will be excluded if there is evidence of other conditions or diseases of the skin or joints, as well as evidence of partial or complete knee joint replacement or anticipated joint replacement in the target knee.
Intervention groups
Two intervention groups (Therapeutic cream: Turmeric, Black Seeds, Flaxseed, and Medicago Sativa and Placebo arm: Placebo cream containing vaseline).
Main outcome variables
The pain, stiffness, and physical function subscales of the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index, Subject Global Evaluation, and the overall WOMAC score.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220614055167N2
Registration date: 2023-01-25, 1401/11/05
Registration timing: prospective

Last update: 2023-01-25, 1401/11/05
Update count: 0
Registration date
2023-01-25, 1401/11/05
Registrant information
Name
Saeid Safiri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3332 7195
Email address
saeidsafiri@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-01, 1402/06/10
Expected recruitment end date
2024-09-01, 1403/06/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Joint Effects of Turmeric, Black Seeds, Flaxseed and Medicago Sativa for relieving symptoms of knee osteoarthritis: A Phase 1-2 Randomized, Double-Blind, Placebo-Controlled Clinical Trial
Public title
Efficacy and safety of Turmeric, Black Seeds, Flaxseed and Medicago Sativa in patients with osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
At least 6 months of diagnosis of knee osteoarthritis, and whose OA diagnosis meets the American College of Rheumatology criteria Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale baseline value of ≥ 9 (0-20 scale) Functional Capacity Classification of I-III Radiograph evidence of OA in the target knee with a Kellgren-Lawrence score of 2 or 3 Morning stiffness of <30 min duration or crepitus on active motion, which is present upon examination
Exclusion criteria:
Evidence of other conditions or diseases of the skin or joints Evidence of partial or complete knee joint replacement or anticipated joint replacement in the target knee Contraindications to the use of non-steroidal anti-inflammatory drugs (NSAIDs) or who use anticoagulant therapy that prohibits them from using NSAIDs Pregnancy, planning to become pregnant or breastfeeding during the study period Ischemic heart disease, heart failure, end-stage cirrhosis, end-stage renal failure, or psychiatric conditions that prevent an adequate evaluation of the study outcomes Insufficient cognitive functioning to participate and complete the questionnaires Unable or unwilling to follow up and complete the study pathway, A history or diagnosis of other arthritic conditions, such as rheumatoid arthritis, joint and bone deformities, fibromyalgia and/or other inflammatory and immune system disorders Type I or II diabetes or obesity (body mass index ≥ 39) Suffering from painful conditions or frequent headaches requiring the use of systemic opiates or derivatives, or the need for additional NSAID or COX-2 inhibitors Receiving systemic or intra-articular corticosteroid injections. Having active cancer undergoing treatment that prevents the evaluation of the outcome measures
Age
From 40 years old
Gender
Both
Phase
1-2
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Using balanced block randomization, patients will be enrolled in one of the two groups, intervention (mixed cream of turmeric, flax seeds, Medicago Sativa, and black seeds) or placebo. The randomization sequence will be performed by an individual who will not participate in the current study. Moreover, the aforementioned randomization method reduces the chances of predicting and manipulating the randomization process and will lead to balanced sample sizes in both groups, both during the study and at the end of the study. The patients will all receive sealed boxes that are numbered with 10-digit codes and contain either the intervention or placebo creams.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patients will receive the boxes sealed with 10-digit codes and in the container of the original drug or placebo, and they will not be aware of the type of drug received, and the researcher will ensure the blinding of the patients. Also, doctors, researchers, and those responsible for the implementation of the project will not be aware of the type of medicine received by the patients 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 Tabriz University of Medical Sciences
Street address
Azadi St., Golgasht Ave., Tabriz University of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Approval date
2023-01-09, 1401/10/19
Ethics committee reference number
IR.TBZMED.REC.1401.912

Health conditions studied

1

Description of health condition studied
Knee osteoarthritis
ICD-10 code
M17.9
ICD-10 code description
Osteoarthritis of knee, unspecified

Primary outcomes

1

Description
Joint pain
Timepoint
Day 0, 30, 60, 90 post intervention
Method of measurement
Western Ontario and McMaster Universities Osteoarthritis Index pain, joint stiffness and physical function subscales

2

Description
Joint stiffness
Timepoint
Day 0, 30, 60, 90 post intervention
Method of measurement
Western Ontario and McMaster Universities Osteoarthritis Index pain, joint stiffness and physical function subscales

3

Description
Physical function
Timepoint
Day 0, 30, 60, 90 post intervention
Method of measurement
Western Ontario and McMaster Universities Osteoarthritis Index pain, joint stiffness and physical function subscales

4

Description
Overall Western Ontario and McMaster Universities Osteoarthritis score
Timepoint
Day 0, 30, 60, 90 post intervention
Method of measurement
Western Ontario and McMaster Universities Osteoarthritis Index

5

Description
Subjective Global Evaluation (SGE)
Timepoint
Day 0, 30, 60, 90 post intervention
Method of measurement
Subjective Global Evaluation forms

Secondary outcomes

1

Description
Quality of life
Timepoint
Day 0, 30, 60, 90 post intervention
Method of measurement
Evaluation of patient’s quality of life, which will be measured using the 36-Item Short Form Survey which produces Mental Component and Physical Component scores

2

Description
Quality of sleep
Timepoint
Day 0, 30, 60, 90 post intervention
Method of measurement
The quality of sleep, which will be measured using the Pittsburgh Sleep Quality Index.

3

Description
Functional Capacity Classification
Timepoint
Day 0, 30, 60, 90 post intervention
Method of measurement
Functional Capacity Classification will be evaluated using a 4-point Likert scale and will be evaluated by the doctor and placed into 4 classes (Class I-IV), which range from full functional capacity to disabled.

Intervention groups

1

Description
Intervention group: Cream containing Turmeric, Black Seeds, Flaxseed, and Medicago Sativa
Category
Treatment - Drugs

2

Description
Control group: Vaseline cream
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Tabriz University of Medical Sciences
Full name of responsible person
Saeid Safiri
Street address
Golgasht St.
City
Tabriz
Province
East Azarbaijan
Postal code
5166/15731
Phone
+98 51 5566 8474
Email
saeidsafiri@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Saeid Safiri
Street address
Golgasht St.
City
Tabriz
Province
East Azarbaijan
Postal code
5155668474
Phone
+98 41 3335 5948
Email
saeidsafiri@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
80
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
Tabriz University of Medical Sciences
Full name of responsible person
Saeid Safiri
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
Azadi St., Golgasht Ave., Tabriz University of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5165665931
Phone
+98 41 3332 7195
Fax
Email
saeidsafiri@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Saeid Safiri
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
Azadi St., Golgasht Ave., Tabriz University of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5165665931
Phone
+98 41 3332 7195
Fax
Email
saeidsafiri@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Saeid Safiri
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
Azadi St., Golgasht Ave., Tabriz University of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5165665931
Phone
+98 41 3332 7195
Fax
Email
saeidsafiri@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no additional information.
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All of the information will be available to all after publishing without the personal information of participants.
When the data will become available and for how long
After publishing the papers
To whom data/document is available
All researchers that are confirmed by the principal investigator
Under which criteria data/document could be used
All of the data will be available except the personal information of the participants
From where data/document is obtainable
The principal investigator
What processes are involved for a request to access data/document
After sending the request by e-mail to the principal investigator, the requests will be evaluated by the team within one month, and if it is approved by the members, the requested information will be sent within three to four months from the time of the request.
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