Objective: To evaluate the effect of topical formulation of Trachyspermum ammis fruit essential oil on the reduction of chronic pain of joints and its comparison with conventional medicine
Design
Clinical trial in phase 2, with control group, Parallel, Non-blind, Non-randomized with 20 samples in each group
Settings and conduct
The study is conducted in Ahmadieh clinic, on patients referred to the center
Participants/Inclusion and exclusion criteria
Age over 60, suffering from osteoarthritis in knee, not having severe pain, Lack of history of related surgery, lack of cancer and significant signs of psychiatric disorders, non-use of narcotics, lack of severe chronic disease, no analgesic injection into the knee joint, in 30 days before or during the intervention period.
Intervention groups
1- Group one: Recieving Ajwain Topical gel and Diclofenac topical gel to be aaplied on the pain area, with 15 min interval, for 1 month
2- Group two: Receiving Diclofenac topical gel to be aaplied on the pain area, for 1 month
Main outcome variables
Pain severity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160306026938N6
Registration date:2018-10-07, 1397/07/15
Registration timing:registered_while_recruiting
Last update:2018-10-07, 1397/07/15
Update count:0
Registration date
2018-10-07, 1397/07/15
Registrant information
Name
Mahdi Vazirian
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6412 1223
Email address
vazirian_m@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-07, 1397/07/15
Expected recruitment end date
2018-12-06, 1397/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of a topical formulation of Trachyspermum ammi fruit essential oil efficacy in reducing chronic arthritic pains (a 2A phase clinical study)
Public title
Evaluation of the effect of ajwain topical formulation in reducing chronic joint pains
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Informed consent for taking part in the study
Age between 60-80 years old
Suffering from osteoarthritis pain in one or both knees
Having an acceptable cognitive ability based on a short cognitive test (AMT)
Exclusion criteria:
Having severe pain, Visual Analogue Scale (VAS) more than 90
History of any surgery related to this disease on the intended joint
Cancer (current or any time before) and obvious symptoms of neuropsychiatric disorders
Chronic use of opiates
Sever chronic diseases, such as insulin-dependent diabetes
Injection of analgesic within the joint in 30 days before the intervention or any programe for injection until the end of the intervention period
Age
From 60 years old to 80 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Siences
Street address
Tehran University of Medical Sciences, Qods street corner, Keshavarz Blvd, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2018-02-05, 1396/11/16
Ethics committee reference number
IR.TUMS.PSRC.REC.1396.4447
Health conditions studied
1
Description of health condition studied
Osteoarthritis
ICD-10 code
M15.0
ICD-10 code description
Primary generalized (osteo)arthritis
Primary outcomes
1
Description
Pain through visual and Likert measurements
Timepoint
At the beginning of the study (before the intervention), one week and one month after commencement of topical use of Trachyspermum ammi.
Method of measurement
Ontario and Master Osteoarthritis Index and KOOS (knee osteoarthritis outcome) questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Ajwain essential oil (one percent) in topical formulation, will applied in pain area, two times a day alongside Diclofenac gel for one month
Category
Treatment - Drugs
2
Description
Diclofenac gel will applied in pain area, two times a day, for one month
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of traditional medicine, Tehran university of medical sciences
Full name of responsible person
Dr. Mehrdad Karimi
Street address
No. 27, North Sarparast Ave. West Taleghani Ave, Palestine Square
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 6697 6527
Email
vazirian_m@tums.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Vice-chancellor of research and technology, Tehran university of medical sciences
Street address
Central organization of Tehran university of medical sciences, corner of Ghods Ave., Keshavarz Boulevard
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3619
Email
rmo@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Dr.Mahdi Vazirian
Position
PhD of Pharmacognosy
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Pharmacognosy Lab., Second Floor, New buliding, Faculty of Pharmacy, In front of Oruji Alley, 16th Azar Ave., Enqelab Ave.
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 6412 1223
Email
Vazirian_m@tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mahdi Vazirian
Position
PhD of Pharmacognosy
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Pharmacognosy Lab., Second Floor, New buliding, Faculty of Pharmacy, In front of Oruji Alley, 16th Azar Ave., Enqelab Ave.
City
tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 6412 1223
Email
vazirian_m@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mahdi Vazirian
Position
PhD of Pharmacognosy
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Pharmacognosy Lab., Second Floor, New buliding, Faculty of Pharmacy, In front of Oruji Alley, 16th Azar Ave., Enqelab Ave
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 6412 1223
Email
vazirian_m@tums.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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Data would be accessible in related dissertation
When the data will become available and for how long
The onset of access from 2020
To whom data/document is available
All the people
Under which criteria data/document could be used
The documents could be accessible in case of furthur experiments
From where data/document is obtainable
Iran, Tehran, Tehran University of Medical Sciences, Faculty of Pharmacy, Dr. Mahdi Vazirian
What processes are involved for a request to access data/document