Formulation of traditional preparation of “shevid marham”and a novel topical drug delivery form the essential oil a of Dill (Anethum graveolens) and study of their effect on pain in osteoarthiritis of knee.
Formulation of traditional preparation of “shevid marham”and a novel topical drug delivery form the essential oil a of Dill (Anethum graveolens) and study of their effect on pain in osteoarthiritis of knee.
Design
According to similar studies, 90 patients were randomly assigned to receive the drug and placebo. And receive the drug with the code.
Settings and conduct
The research area is Pasteur Bam Hospital. After completing three to four weeks (once daily twice and once per gram), the relevant questionnaires (VAS, WOMAC) are completed.
Participants/Inclusion and exclusion criteria
1. Primary knee osteoarthritis patients aged 40 to 80 years
2. Joint pain of osteoarthritis with or without symptoms
3. Significant radiological symptoms of knee osteoarthritis
4. Qualify for patients with knee osteoarthritis according to American Rheumatology Association criteria
Exit criteria:
1. Patients with acute phase of knee arthritis
2. Having secondary osteoarthritis (such as severe joint trauma and mathologic diseases)
3. Failure to track enough
4. Diabetic neuropathy
Intervention groups
. Traditional form recipient
• Recipient of sesame oil (placebo)
• New form recipient
• Recipient of all new formulations without active substance (placebo)
• Recipient of diclofenac ointment (positive control)
Main outcome variables
Intensity of pain
The amount of pain in different situations
Percentage of active ingredients in the formulation
Duration of treatment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170702034861N7
Registration date:2019-02-27, 1397/12/08
Registration timing:registered_while_recruiting
Last update:2019-02-27, 1397/12/08
Update count:0
Registration date
2019-02-27, 1397/12/08
Registrant information
Name
Fariba Sharififar
Name of organization / entity
Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3132 5020
Email address
fsharififar@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Research project
Expected recruitment start date
2019-02-20, 1397/12/01
Expected recruitment end date
2019-04-30, 1398/02/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Formulation of traditional preparation of “shevid marham”and a novel topical drug delivery form the essential oil a of Dill (Anethum graveolens) and study of their effect on pain in osteoarthiritis of knee.
Public title
The effect of anethum graveolens on pain relief from arthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Primary knee osteoarthritis patients aged 40 to 80
Joint pain of osteoarthritis with or without symptoms
Radiological Signs of Knee Arthritis
Patients of Knee Osteoarthritis according to American Rheumatology Association criteria
Exclusion criteria:
Patients with acute phase of knee arthritis
Secondary osteoarthritis (such as severe joint trauma and rhomathologic diseases)
Inability to keep track of enough
Diabetic neuropathy
Age
From 40 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, randomly assigned to intervention and control groups.This method uses simple randomization models, such as using random numbers tables or using computer randomization methods, and places each referer, for example, by dropping a coin, into an intervention or control group. The implementation of this method is very simple. The disadvantages of this method are that the sample size of a group may be more than the other. One type of intervention may be given at the beginning of the study and a type of intervention at the end of the study
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants and main investigators have been blinded. Patient safety is a priority, so the physician should be informed about the patient's treatment. After randomization of the patients in the intervention and control groups, the drug and placebo with the same appearance will administer to the patient who is blind to the type of medicine. The original researcher is also completely blind to the drug. Medication and placebo are provided to the physician and provided to the patient by him or her. Analysis of the results will be done by a statistics who is not necessarily the original researcher.
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
Ibn Sina St,Tahmasebabad Crossroads
City
Kerman
Province
Kerman
Postal code
7619813159
Approval date
2019-02-18, 1397/11/29
Ethics committee reference number
IR.KMU.REC.1397.462
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
Timepoint
14 day
Method of measurement
The Western Ontario and McMaster Universities Osteoarthritis Index
Secondary outcomes
1
Description
Percentage of active ingredients
Timepoint
Once
Method of measurement
GC-MASS
Intervention groups
1
Description
Make up to one gram twice a day, topically
Category
Treatment - Drugs
2
Description
novel formulation of extracts and essential oils in a dose of 1 gram twice a day
Category
Treatment - Drugs
3
Description
Sesame oil is 1 g twice a day
Category
Placebo
4
Description
novel formulation except active ingredient One gram twice a day
Category
Placebo
5
Description
diclofenac ointment One gram twice a day
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Pastor hospital
Full name of responsible person
Mazyar Oveisi
Street address
No. 10,Imam Blvd
City
Bam
Province
Kerman
Postal code
7661631658
Phone
+98 34 4421 4611
Email
Setareh5307@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Fariba Sharififar
Street address
Ibn Sina St,Tahmasebabad crossroads
City
Kerman
Province
Kerman
Postal code
7619813159
Phone
+98 34 3132 5020
Email
Fsharififar@kmu.ac.ir
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 Science
Full name of responsible person
Setareh Saei
Position
Traditional Pharmaceutical Assistant
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Faculty of Traditional Pharmacy
City
Kerman
Province
Kerman
Postal code
7619813159
Phone
+98 34 3132 5020
Fax
Email
setareh5307@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman university of medical sciences
Full name of responsible person
Fariba Sharififar
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy,
City
Kerman
Province
Kerman
Postal code
7619813159
Phone
+34 31325020
Fax
Email
fsharififar@kmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Science
Full name of responsible person
Setareh Saei
Position
Traditional Pharmaceutical Assistant
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Faculty of Traditional Pharmacy
City
Kerman
Province
Kerman
Postal code
7619813159
Phone
+98 34 3132 5020
Fax
Email
Setareh5307@gmail.com
Web page address
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
data of unidentifiabe of participants
When the data will become available and for how long
After complete data analysis and presentation of final report
To whom data/document is available
due to publication of data, there is no limitation
Under which criteria data/document could be used
There are no limitations.
From where data/document is obtainable
with main researcher
What processes are involved for a request to access data/document
communication through e- mail and response recieving