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The effect of a Curcumin organogel on knee osteoarthritis: a randomized placebo trial

Protocol summary

Study aim
Evaluation of the effect of Curcumin organogel in the treatment of knee osteoarthritis
Design
Clinical trial with control group, double-blind, randomized, on 70 patients. Three-digit randomization code number was used for randomization
Settings and conduct
The study will be performed in the clinic on the randomly allocated patient using The Western Ontario and McMaster Universities Arthritis Index (WOMAC) questionnaires and the final evaluation will be done by a caregiver.
Participants/Inclusion and exclusion criteria
Inclusion criteria: having symptoms of pain in joint Osteoarthritis (at the Knee), stiffness, difficulty in flexion and extension, swelling for more than 3 months prior to the study, being free of any systemic or dermatological diseases, willing to refrain from using any lotion, gel, balm, moisturizer, cleanser, cosmetic or cream on the treatment areas during the treatment period, being able to give written informed consent in a manner approved by the Institutional Ethics Committee and complying with the requirements of the study, willing to avoid participation in any other interventional clinical trial for the duration of the current study and having no allergy to Curcumin and plants of the ginger family. Exclusion criteria include: showing a systemic or local allergic reaction to Curcumin OG, discontinuation of the treatment before the end of the intervention, or stopping it for at least three consecutive days, a decision to withdraw from the study, death, hospitalization, and moving to another city.
Intervention groups
In current study, the effect of Curcumin OG on the symptoms of patient suffering from knee osteoarthritis will be evaluated in comparison with the patients receiving Curcumin-free OG as placebo.
Main outcome variables
Reducing pain, stiffness and difficulty in knee movement of patients.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220531055045N1
Registration date: 2022-06-11, 1401/03/21
Registration timing: prospective

Last update: 2022-06-11, 1401/03/21
Update count: 0
Registration date
2022-06-11, 1401/03/21
Registrant information
Name
mohsen mohammady
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 4252 5694
Email address
mohsenmohamady@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-06-06, 1401/03/16
Expected recruitment end date
2022-08-07, 1401/05/16
Actual recruitment start date
2022-06-16, 1401/03/26
Actual recruitment end date
2022-08-17, 1401/05/26
Trial completion date
2022-09-06, 1401/06/15
Scientific title
The effect of a Curcumin organogel on knee osteoarthritis: a randomized placebo trial
Public title
Curcumin organogel for osteoarthritis treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having symptom of pain in joint Osteoarthritis (at Knee), stiffness, difficulty in flexion and extension, swelling for more than 3 months prior to the study Being free of any systemic or dermatological diseases Willing to refrain from using any lotion, gel, balm, moisturizer, cleanser, cosmetic or cream on the treatment areas during the treatment period Being able to give written informed consent in a manner approved by the Institutional Ethics Committee and complying with the requirements of the study Willing to avoid participation in any other interventional clinical trial during current study No known allergy to Curcumin and plants of the ginger family
Exclusion criteria:
Showing a systemic or local allergic reaction to Curcumin organogel Discontinuation of the treatment before end of intervention, or stopping it for at least three consecutive days A decision to withdraw from the study Death Hospitalization Moving to another city
Age
From 50 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
Sample size
Target sample size: 70
Actual sample size reached: 75
Randomization (investigator's opinion)
Randomized
Randomization description
Computer-generated randomization is employed, and the subjects are assigned with a three-digit randomization code number
Blinding (investigator's opinion)
Double blinded
Blinding description
After definite diagnosis of osteoarthritis and agreement to participate in the study, the patients will be interviewed and practically trained on how to use the Curcumin OGs. The patients in the intervention group will receive Curcumin OGs and the patients in the placebo group will receive curcumin-free placebo gels. However, both groups will receive similar educations and have no contact with each other. The clinical observer and the outcome assessor will also have no knowledge of the type of intervention during the study.
Placebo
Used
Assignment
Other
Other design features
not included.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences
City
shiraz
Province
Fars
Postal code
۷۱۴۶۸۶۴۶۸۵
Approval date
2022-04-30, 1401/02/10
Ethics committee reference number
IR.SUMS.AEC.1401.006

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
Pain, Stiffness, Difficulty in knee movement
Timepoint
Before, 1, 2, 4 and 8 weeks after intervention.
Method of measurement
The Western Ontario and McMaster Universities Arthritis Index

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Applying Curcumin OG 2% twice a day for 8 weeks on the knee area.
Category
Treatment - Drugs

2

Description
Control group: Applying Curcumin-free OG, twice a day, up to 8 weeks, on the knee area.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Shiraz University of Medical Sciences Clinics
Full name of responsible person
Gholamhossein Yousefi
Street address
Karimkhan Zand Street, Shiraz University of Medical Sciences Clinics
City
Shiraz
Province
Fars
Postal code
۷۱۴۶۸۶۴۶۸۵
Phone
+98 71 3242 5374
Email
ghyousefi@sums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Gholamhossein Yousefi
Street address
Department of pharmaceutics, school of pharmacy, karafarin street, Shiraz Town, Iran
City
Shiraz
Province
Fars
Postal code
7146864685
Phone
+98 71 3242 4127
Email
ghyousefi@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Personal
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons

Person responsible for general inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Gholamhossein Yousefi
Position
Associate Professor of Pharmaceutics
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Department of pharmaceutics, school of pharmacy, karafarin street, Shiraz Town, Iran
City
Shiraz
Province
Fars
Postal code
7146864685
Phone
+98 71 3242 4127
Email
ghyousefi@sums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Gholamhossein Yousefi
Position
Associate Professor of Pharmaceutics
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Shiraz
City
Shiraz
Province
Fars
Postal code
7146864685
Phone
+98 71 3242 5305
Email
Ghyousefi@sums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Gholamhossein yousefi
Position
Associate Professor of Pharmaceutics
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Shiraz
City
Shiraz
Province
Fars
Postal code
7146864685
Phone
+98 71 3242 5305
Email
Ghyousefi@sums.ac.ir

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
Patients' information, Methodology and Results.
When the data will become available and for how long
As soon as the results are provided.
To whom data/document is available
People working in academic institutions or people working in pharmaceutical industries.
Under which criteria data/document could be used
Statistical and scientific analyses with respecting to intellectual rights
From where data/document is obtainable
Dr. Gholamhossein Yousefi using the phone 09123956292
What processes are involved for a request to access data/document
Contact with investigators and official request expressing the reasons and the how of using data.
Comments
Any usage of information is solely permitted via official channels and by informing and citing to the investigators.
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