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The effect of topical Pistacia vera oil on clinical signs and symptom of knee joint osteoarthritis: a randomized and double blind clinical trial

Protocol summary

Study aim
The effect of topical Pistacia vera oil on clinical signs and symptom of knee joint osteoarthritis: a randomized and double blind clinical trial
Design
A double-blind, placebo-controlled clinical trial by simple randomization method
Settings and conduct
Clinical trial will be performed in the first half of the year on osteoarthritis patients referred to Rafsanjan Rheumatology Clinic. Diagnosis is made with the American College of Rheumatology. Pain, morning stiffness, range of motion, and function of patients in each of the three intervention groups will be assessed at the beginning and the end of the study using the Visual Analogue Scale(VAS) and Western Ontario and Mc Master(WOMAC). In order to double-blind the study, Clinical symptoms are assessed by a rheumatologist who is not aware of the type of medication used by each individual.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 45-70 years, average knee pain within 24 hours based on VAS between 4 and 7 and Exclusion criteria: Patients with inflammatory diseases (such as lupus, rheumatoid arthritis, history of brucellosis, etc.), cancer, Symptoms or history of hepatic or renal failure, oral corticosteroid consumption over the past 4 weeks, corticosteroid injection over the past 6 months, fever, consumption of medical herbs continuously, smoking, pistachio allergy, use of food or drug supplements, oral use of other analgesics and other compounds effective in treating osteoarthritis up to 10 days before the study, skin or infectious disease or ulcer at the place of administration, pregnancy
Intervention groups
Patients in group A: pyroxicam gel, in group B: pistachio oil, and in group C, will be used on the basis of Farabi
Main outcome variables
Pain and status of osteoarthritis in terms of morning stiffness, range of motion and function of patients

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180811040759N1
Registration date: 2019-09-09, 1398/06/18
Registration timing: retrospective

Last update: 2019-09-09, 1398/06/18
Update count: 0
Registration date
2019-09-09, 1398/06/18
Registrant information
Name
Mitra Abbasifard
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3428 0040
Email address
dr.mabbasifard@rums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-21, 1398/01/01
Expected recruitment end date
2019-06-22, 1398/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of topical Pistacia vera oil on clinical signs and symptom of knee joint osteoarthritis: a randomized and double blind clinical trial
Public title
The effect of topical Pistacia vera oil on knee joint osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
age 45-70 years diagnosis of knee osteoarthritis according to American College of Rheumatology, approved by rheumatology specialist the average knee pain within 24 hours is based on the linear-visual pain scale (VAS) between 4 to 7
Exclusion criteria:
Patients with inflammatory diseases (such as lupus, rheumatoid arthritis, history of brucellosis, etc.) cancer or chronic diseases symptoms or history of liver or kidney failure oral corticosteroid consumption during the past 4 weeks corticosteroid injection in the last 6 months fever Consumption of medical herbs continuously Smoking pistachio allergy use of food and drug supplements Oral use of other analgesics and other compounds effective in treating osteoarthritis up to 10 days before the study Skin or infectious disease or ulcer at the place of administration pregnancy
Age
From 45 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 75
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization method. Unit: individual, simple random instrument: dice throwing one and two numbers for group A and numbers three and four for group B and numbers five and six for group C and completing groups with this sequence. And hiding using randomly encoded boxes
Blinding (investigator's opinion)
Double blinded
Blinding description
To have double blind study, before the study begins, the drugs will be packaged by someone other than the researcher in the same packages and encoded as A, B, and C.Prescribing by rheumatologist as an A or B or C drug and Delivery is done by someone else
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Rafsanjan University of Medical Sciences
Street address
Ali ibn Abi Talib Square, Ali ibn Abi Talib Hospital
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Approval date
2019-01-01, 1397/10/11
Ethics committee reference number
IR.RUMS.REC.1397.175

Health conditions studied

1

Description of health condition studied
Osteoarthritis
ICD-10 code
M17
ICD-10 code description
Osteoarthritis of knee

Primary outcomes

1

Description
Knee pain intensity
Timepoint
At the beginning and the end of the study (three months after the beginning of the study)
Method of measurement
The linear-visual scale of pain

2

Description
morning stiffness & Patients' function
Timepoint
At the beginning and the end of the study (three months after the beginning of the study)
Method of measurement
WOMAC questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Group A is used topically in the pyroxicam gel. The treatment duration is 3 months and twice daily. During the study, patients are only allowed to use oral analgesics (7.5 mg of meloxicam) once daily in all groups if needed, and none of the common drugs will be used during this period.
Category
Treatment - Drugs

2

Description
Intervention group: Group B is used topically for pistachio oil. The treatment duration is 3 months and twice daily. During the study, patients are only allowed to use oral analgesics (7.5 mg of meloxicam) once daily in all groups if needed, and none of the common drugs will be used during this period.
Category
Treatment - Drugs

3

Description
Control group: Group C is used topically from the base of Farabi, which is a ready-made and non-effective drug base, along with color for placebo. The treatment duration is 3 months and twice daily. During the study, patients are only allowed to use oral analgesics (7.5 mg of meloxicam) once daily in all groups if needed, and none of the common drugs will be used during this period.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Rheumatology Clinic of Rafsanjan University of Medical Sciences
Full name of responsible person
Dr. Mitra Abbasi Fard
Street address
Ali ibn Abi Talib Square, Ali ibn Abi Talib Hospital
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0038
Email
dr.mabbasifard@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Dr. Ali Shamsi Zadeh
Street address
Imam Ali Street, Central Authority
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0038
Email
info@rums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rafsanjan 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
Rafsanjan University of Medical Sciences
Full name of responsible person
Fateme nazhadkoorki
Position
medical student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Ali ibn Abi Talib Square, Ali ibn Abi Talib Hospital
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0038
Email
fatemenezhadi@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Fateme nezhadkoorki
Position
medical student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Ali ibn Abi Talib Square, Ali ibn Abi Talib Hospital
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0038
Email
fatemenezhadkoorki@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Fatemenezhadkoorki
Position
medical student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Ali ibn Abi Talib Square, Ali ibn Abi Talib Hospital
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0038
Email
fatemenezhadkoorki@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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