Local analgesics for pain control can provide effective local approach. Local agents have similar efficacy without systemic side effects of oral formulations. Plants are rich and intact source of compounds and medical plants have been used without any significant side effects in traditional medicine since ages. In this study N.oleander extract was studied due to its use in traditional medicine as an analgesic in pain management. The present study is a clinical trial and double blind study. Patients with primary ostheoarthritis in at least one knee, will randomly divide into two groups. Group I(30 patient) receive N.oleander gel, Group II(30 patient) Diclofenac gel. All drugs will use in simillar pakage with different code. At the beginig of the experiment and 30 days after the usage of drug the WOMAC indexes will examine.
General information
Acronym
Defli oil effect
IRCT registration information
IRCT registration number:IRCT2013111615413N1
Registration date:2014-02-12, 1392/11/23
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-02-12, 1392/11/23
Registrant information
Name
Mohammad Askarfarashah
Name of organization / entity
Faculty of Traditional medicine - Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5560 1274
Email address
askarfarashah.itm@gmail.com
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2013-12-22, 1392/10/01
Expected recruitment end date
2014-04-21, 1393/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation and comparisson of N.oleander and Diclofenac gel in patients with knee osteoartheritis : A randomized, double-blind, controlled trial.
Public title
Evaluation and comparisson of Defli oil and Diclofenac gel in patients with knee osteoartheritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Out-patients aged 50-80 years who suffer osteoarthritis based on clinical and radiological criteria of ACR included participants.
Exclusion criteria:
Secondary osteoarthritis; trauma; Endocrine disease(hyperthyroid,hypothyroid ,Diabet); Metabolic disease; other arthritis disease; corticosteroid usage; Joint replacement; concomitant usage in glucosamine and chondroitin sulfate; Intra-articular injection during last 3 months; usage of muscle relaxants drugs; pregnancy; anti-depression; patients suffering from heart; lung; liver; kidney and peptic ulcer and finally patients with proven hypersensitivity to drugs used in this study.
Age
From 50 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
In the present study, there were positive control group instead of placebo group.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee, Faculty of Traditional Medicine, Tehran University of Medical Sciences
Street address
Keshavarz Blv Ghods St Tehran
City
Tehran
Postal code
1417653761
Approval date
2013-10-08, 1392/07/16
Ethics committee reference number
1461/130/د/92
Health conditions studied
1
Description of health condition studied
Osteoarthritis of knee
ICD-10 code
M19.0
ICD-10 code description
Primary arthrosis of other joints
Primary outcomes
1
Description
pain
Timepoint
Before and after the treatment
Method of measurement
WOMAC questionnaire
2
Description
stifness
Timepoint
Before and after the treatment
Method of measurement
WOMAC questionnaire
Secondary outcomes
1
Description
physical function
Timepoint
befor and after intervention
Method of measurement
questionnaire WOMAC
Intervention groups
1
Description
Group I: receive topical consumption of defli oil. Every 8 hour on all of site of knee for 30 days
for 30days
Category
Treatment - Drugs
2
Description
receive topical consumption of Diclofenac gel. Every 8 hour on all of site of knee for 30 days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Sadughi Hospital
Full name of responsible person
Mohammad Askarfarashah
Street address
Ghandi Blv Shahid Sadughi Hospital
City
yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Dr. Minaei; Vice chancellor for research Traditional Medicine Faculty of Tehran University of Medica
Full name of responsible person
Dr. Minaei
Street address
Behesht Street, Vahdat eslami Ave.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Dr. Minaei; Vice chancellor for research Traditional Medicine Faculty of Tehran University of Medica
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Traditional Medicine Faculty, Tehran University of Medical Sciences
Full name of responsible person
Mohammad Askarfarashah
Position
PhD candidate
Other areas of specialty/work
Street address
Behesht Ave., Vahdat eslami St.
City
Tehran
Postal code
1114733311
Phone
+98 21 5560 1274
Fax
+98 21 5569 3520
Email
askarfarashah.itm@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Seyyed Reza Najafizade
Position
Assistant Professor
Other areas of specialty/work
Street address
Emam Khomeini Hospital ,keshavarz Blvd
City
Tehran
Postal code
1419733141
Phone
+98 21 6693 9001
Fax
+98 21 6691 1294
Email
Najafisr@tums.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Traditional Medicine Faculty of Tehran Medical Colledge
Full name of responsible person
Mohammad Askarfarashah
Position
PhD candidate
Other areas of specialty/work
Street address
Behesht Ave., Vahdat eslami St.
City
Tehran
Postal code
114733311
Phone
+98 21 5560 1274
Fax
+98 21 5569 3520
Email
askarfarashah.itm@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)