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A clinical trial comparing the effects of Galbanum oil and Diclofenac gel in patients pain with osteoarthritis of the knee

Protocol summary

Summary
Effects of Galbanum oil on patients pain with osteoarthritis of the knee, blocked randomized, single blind, control with standard medication, single center, phase 2 trial, inclusion criteria: eighteen to eighty years old; at least one knee pain lasting one month; radiographic changes including osteophyte and joint space narrowing(grade 1,2,3); pregnancy test in fertile women. Exclusion criteria: active infectious disease; skin lesion in knee; renal failure; knee surgery in 2 last months; alcohol or opioid abuse; pregnancy or breastfeeding; allergy to oil, sample size: 30 intervention: intervention group give Galbanum oil, oral acetaminophen and quadriceps femoris exercise and control group give topical Diclofenac gel, oral acetaminophen and quadriceps femoris exercise, intervention time: 4 weeks, primary outcome: knee pain severity, knee stiffness, pain interfering with daily activity and patients quality of life.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014102719699N1
Registration date: 2015-04-29, 1394/02/09
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-04-29, 1394/02/09
Registrant information
Name
Majid Khamessi
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8214 1679
Email address
khamesi.majid@yahoo.com
Recruitment status
Recruitment complete
Funding source
Myself
Expected recruitment start date
2014-10-23, 1393/08/01
Expected recruitment end date
2015-02-20, 1393/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A clinical trial comparing the effects of Galbanum oil and Diclofenac gel in patients pain with osteoarthritis of the knee
Public title
Effect of Galbanum oil on pain of the knee arthrosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: eighteen to eighty years old; at least one knee pain lasting one month; radiographic changes including osteophyte and joint space narrowing (grade 1,2,3); pregnancy test in fertile women. Exclusion criteria: active infectious disease; skin lesion in knee; renal failure; knee surgery in 2 last months; alcohol or opioid abuse; pregnancy or breastfeeding; allergy to oil.
Age
From 18 years old to 80 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Patients and analyzers of the data are unaware of the drugs.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
School of medicine, Iran University of Medical Sciences, Hemmat highway between Chamran and Sheikh fazlollah
City
Tehran
Postal code
Approval date
2014-10-14, 1393/07/22
Ethics committee reference number
3296/ 105/ د/ 93

Health conditions studied

1

Description of health condition studied
Knee osteoarthritis
ICD-10 code
M17.0
ICD-10 code description
Primary gonarthrosis, bilateral

Primary outcomes

1

Description
Knee pain severity
Timepoint
Before intervention, one month and two months after intervention
Method of measurement
Visual analog scale

2

Description
Knee pain, stiffness and interference with daily activity
Timepoint
Before intervention, one month and two months after intervention
Method of measurement
WOMAC questionnaire

Secondary outcomes

1

Description
Oral analgesic consumption
Timepoint
Before intervention, one month and two months after intervention
Method of measurement
Check list

2

Description
Skin hypersensitivity reactions
Timepoint
Before intervention, one month and two months after intervention
Method of measurement
Check list

Intervention groups

1

Description
Intervention 1, topical Galbanum oil/3 time a day, Acetaminophen 500 mg/ if needed, Quadriceps femoris exercise/ 3 time a day for 4 weeks. Sixty grams of Galbanum ointment given to each patient. Each gram contains 8.5 mg 1, 8 cineole and created by traditional medicine specialist.
Category
Treatment - Drugs

2

Description
Intervention 2, topical Diclofenac gel/ 3 time a day, Acetaminophen 500 mg/ if needed, Quadriceps femoris exercise/ 3 time a day for 4 weeks. Sixty grams of Diclofenac gel given to each patient. Each gram contains 1 mg Diclofenac sodium and created by Razak company.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Firoozgar hospital
Full name of responsible person
Majid Khamessi
Street address
Department of Physical Medicine and Rehabilitation, Firoozgar hospital, Behafarin street, Valiasr square, Tehran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Iran University of Medical Sciences
Full name of responsible person
Seyed Ali Javad Mousavi
Street address
Vice chancellor for research, Iran University of Medical Sciences, Hemmat highway between Chamran and Sheikh fazlollah, Tehran
City
Tehran
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, Iran 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
Iran University of Medical Sciences
Full name of responsible person
Bijan Forough
Position
Physical Medicine and Rehabilitation specialist
Other areas of specialty/work
Street address
Department of Physical Medicine and Rehabilitation, Firoozgar hospital, Behafarin Street, Valiasr square, Tehran
City
Tehran
Postal code
Phone
+98 21 8214 1679
Fax
+98 912 122 3184
Email
bijanfr@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Majid Khamessi
Position
Physical Medicine and Rehabilitation resident/MD
Other areas of specialty/work
Street address
Department of Physical Medicine and Rehabilitation, Firoozgar hospital, Behafarin Street, Valiasr square, Tehran
City
Tehran
Postal code
Phone
+98 21 8214 1679
Fax
Email
khamesi.majid@yahoo.com; elhamasadinejad@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Majid Khamessi
Position
Physical Medicine and Rehabilitation resident/MD
Other areas of specialty/work
Street address
Department of Physical Medicine and Rehabilitation, Firoozgar hospital, Behafarin Street, Valiasr square, Tehran
City
Tehran
Postal code
Phone
+98 21 8214 1679
Fax
Email
khamesi.majid@yahoo.com; elhamasadinejad@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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