Purpose: Assessment of Sambucus ebulus effect on clinical manifestation of knee Osteoarthritis versus Diclofenac gel :A double blind clinical trial. Study design: This study is a randomized, double-blind, controlled trial. Study population: Patients with primary ostheoarthritis in at least one knee, will randomly divide into two groups. Group I (31 patient) receive sambucus ebulus gel 3 times daily, Group II (31 patient) receive Diclofenac gel 3 times daily. All drugs will use in simillar pakage with different code. Inclusion Criteria: age: 30-60 years; A history of knee pain for at least 3 months; Mild to moderate Osteoarthritis based on Kellegren-Lawrence grading scale; Exclusion Criteria: Allergy to Sambucus ebulus & Diclofenac gel; Skin lesions in the knee; Osteoarthritis secondary to Rheumatic disease such as Rheumatoid Arthritis, Gout, Infectious Arthritis, Metabolic Arthritis, Traumatic Arthritis; Knee joint replacement surgery; Oral and topical steroid therapy within 14 days prior to study; Intra-articular steroid injections within 90 days prior to study; Pregnancy and lactation; Addiction to alcohol and drugs; Radiculopathy and Neuropathy. Time of interventions: The patients will be assessed at initiation,2 and4 weeks after the intervention, using the WOMAC and VAS questionnaire. Main outcome: Pain, stiffness and physical function
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014080318494N1
Registration date:2015-03-20, 1393/12/29
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-03-20, 1393/12/29
Registrant information
Name
Marzie Jabbari
Name of organization / entity
Ardakan Traditional Medicine Faculty, Yazd Shahid Sadoughi University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 35 2723 8916
Email address
marzie.jabbari@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research, Shahid Sadoughei University of Medical Sciences
Expected recruitment start date
2015-02-20, 1393/12/01
Expected recruitment end date
2015-08-23, 1394/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of Sambucus ebulus effect on clinical manifestation of knee Osteoarthritis versus Diclofenac gel :A double blind clinical trial
Public title
Sambucus ebulus effect on knee Osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: age: 30-60 years; A history of knee pain for at least 3 months; Mild to moderate Osteoarthritis (grade 1 and 2) based on Kellegren-Lawrence grading scale; Exclusion Criteria: 1-Allergy to Sambucus ebulus & Diclofenac gel; Skin lesions in the knee; Osteoarthritis secondary to Rheumatic disease such as Rheumatoid Arthritis, Gout, Infectious Arthritis, Metabolic Arthritis, Traumatic Arthritis; Knee joint replacement surgery; Oral and topical steroid therapy within 14 days prior to study; Intra-articular steroid injections within 90 days prior to study; Pregnancy and Lactation; Addiction to alcohol and drugs; Radiculopathy and Neuropathy
Age
From 30 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
94
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee,Yazd Shahid Sadoughei Univesity of Medical Sciences
Street address
Central department of Shahid Sadoughei Medical University, Shahid bahonar squer, Yazd
City
Yazd
Postal code
8916978477
Approval date
2014-09-23, 1393/07/01
Ethics committee reference number
17/1/65403/پ
Health conditions studied
1
Description of health condition studied
knee osteoartritis
ICD-10 code
M19.0
ICD-10 code description
Primary arthrosis of other joints
Primary outcomes
1
Description
Pain
Timepoint
Baseline, 2 and 4 weeks after intervention
Method of measurement
WOMAC questionnaire
2
Description
Stiffness
Timepoint
Baseline, 2 and 4 weeks after intervention
Method of measurement
WOMAC questionnaire
Secondary outcomes
1
Description
physical function
Timepoint
Baseline, 2 and 4 weeks after intervention
Method of measurement
WOMAC questionnaire
Intervention groups
1
Description
Receive topical consumption of sambucus ebulus gel, Every 8 hour on all of site of knee for 30 days
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
Imam Khomeini Hospital
Full name of responsible person
Marzie Jabbari
Street address
Brain and Spinal Cord Research Center, Imam Khomeini Hospital, Keshavarz Blvd, Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research, Shahid Sadoughei University of Medical Sciences
Full name of responsible person
Dr. Fatemeh Ezoddini
Street address
Central Building of Shahid Sadoughei Medical University, Shahid Bahonar squer,Yazd
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research, Shahid Sadoughei University of Medical Sciences
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 of Ardakan, Shahid Sadoughei University of Medical Sciences
Full name of responsible person
Marzie Jabbari
Position
PhD candidate
Other areas of specialty/work
Street address
Imam Khomeini ave
City
Ardakan
Postal code
Phone
+98 35 2723 8917
Fax
+98 35 2724 6330
Email
marzie.jabbari@ssu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Imam Khomeini Hospital
Full name of responsible person
Dr seyede Zahra Emami Razavi
Position
Assistant Professor of Physical Medicine and Rehabilitation
Other areas of specialty/work
Street address
Brain and Spinal Cord Research Center, Imam Khomeini Hospital, Tehran
City
Tehran
Postal code
Phone
+98 21 6119 2291
Fax
Email
zemamirazavi@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Imam Khomeini Hospital
Full name of responsible person
Marzie Jabbari
Position
PhD candidate
Other areas of specialty/work
Street address
Brain and Spinal Cord Research Center, Imam Khomeini Hospital, Tehran
City
Tehran
Postal code
Phone
+98 21 6119 2210
Fax
Email
marzie.jabbari@ssu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)