Protocol summary

Summary
The aim of this study is to compare the analgesic effect of 1% Hedera helix extract gel with 1% Diclofenac gel on knee pain in osteoarthritis patients. It is a double blind randomized clinical trial. The 1% Hedera helix extract, 1% Diclofenac gel and placebo gel will all be set in A,B, and C tubes by a trustworthy third party and will be handed over to the researcher. 150 patients seeking medical care in orthopedic clinics will randomly receive one of the tubes. The main inclusion criteria is primary osteoarthritis in at least one knee confirmed radiologicaly in the knee plain x-ray, presence of pain for at least 2 weeks before the visit and age of 45 years and older. The main exclusion criteria is secondary osteoarthritis, peptic ulcer, taking corticosteroids for any reason, and using any analgesic topical gel on the knee before the study. Before receiving the gel, patient pain will be assessed using VAS and WOMAC questionnaires. Patients will rub the gel on the affected knee for 6 weeks three times a day, each time for 15-20 minutes. All three groups will receive 200 mg Celecoxib capsules simultaneously to subside the pain. After 6 weeks of administration, patients pain, morning stiffness, daytime stiffness and physical function will be assessed again by VAS and WOMAC.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017050133740N1
Registration date: 2017-09-26, 1396/07/04
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-09-26, 1396/07/04
Registrant information
Name
Mahdie Saffari
Name of organization / entity
Shahrekord University of Medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 913 410 4240
Email address
st-saffari.m@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research center of Shahrekord University of Medical Sciences
Expected recruitment start date
2017-05-22, 1396/03/01
Expected recruitment end date
2017-07-23, 1396/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of topical 1% Hedera helix L. extract gel with 1% Diclofenac gel in the treatment of patients with primary knee osteoarthritis referred to orthopedic clinic
Public title
Comparing the effect of topical 1% Avy extract gel with 1% Diclofenac gel in the treatment of patients with primary knee osteoarthritis referred to orthopedic clinic
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Primary osteoarthritis in at least one knee confirmed radiologicaly on a knee x-ray; Pain presence from at least 2 weeks prior to visit; Age> 45. Exclusion criteria: Secondary osteoarthritis; Active liver or kidney disease; Peptic ulcer disease; Diabetes; Thyroid or parathyroid diseases; Coagulopathy or taking anti-coagulatory drugs; Ischemic or hemorrhagic CVA; Past history of deep vein thrombosis; Allergy to any form of anti-inflammatory agents, Acute trauma; Alcohol use; Drug abuse; Skin diseases, infection or wound on the site of the study; Corticosteroid use in any form; Using other topical agents on the site of the study; Taking oral agents effective on osteoarthritis within 10 days from the start of the study; Pregnancy; History of the site fracture; Deformities leading to osteoarthritis; Congenital joint diseases.
Age
From 45 years old to 139 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 150
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research center of Shahrekord University of Medical Sciences
Street address
Shahrekord University of Medical Sciences, Kashani Blv.
City
Shahrekord
Postal code
Approval date
2017-02-19, 1395/12/01
Ethics committee reference number
IR.SKUMS.REC.1395.40

Health conditions studied

1

Description of health condition studied
Gonarthrosis
ICD-10 code
M17.1l
ICD-10 code description
Other primary gonarthrosis Primary gonarthrosis: NOS unilatera

Primary outcomes

1

Description
Pain
Timepoint
Before and after intervention
Method of measurement
VAS and WOMAC questionnaires

2

Description
Morning stiffnes
Timepoint
Before and after intervention
Method of measurement
VAS and WOMAC questionnaires

3

Description
Stiffness during the day
Timepoint
Before and after intervention
Method of measurement
VAS and WOMAC questionnaires

4

Description
Physical function
Timepoint
Before and after intervention
Method of measurement
VAS and WOMAC questionnaires

Secondary outcomes

empty

Intervention groups

1

Description
1% Hedera helix extract gel, topical use, three times a day.
Category
Treatment - Drugs

2

Description
1% Diclofenac gel, topical use, three times a day.
Category
Treatment - Drugs

3

Description
Placebo gel, topical use, three times a day.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Specialty clinic of Imam Ali of Shahrekord
Full name of responsible person
Morteza Dehghan MD
Street address
Shariati st.
City
Shahrekord

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research center of Shahrekord University of Medical Sciences
Full name of responsible person
Dr Kamal Solati
Street address
Shahrekord University of Medical Sciences, Kashani Blvd.
City
Shahrekord
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 center of Shahrekord 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
Shahrekord University of Medical Sciences
Full name of responsible person
Mahdie Saffari
Position
Medical student
Other areas of specialty/work
Street address
Hajar hospital, Parastar st.
City
Shahrekord
Postal code
Phone
+98 38 3222 0016
Fax
Email
mahdiesaffari@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Morteza Dehghan
Position
Orthopedist
Other areas of specialty/work
Street address
Kashani hospital, Parastar st.
City
Shahrekord
Postal code
Phone
+98 38 3226 4825
Fax
Email
dehghan_morteza@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Mahdie Saffari
Position
Medical student
Other areas of specialty/work
Street address
Hajar hospital, Parastar st.
City
Shahrekord
Postal code
Phone
00
Fax
Email
mahdiesaffari@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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