Determine the effect of Dazen Ointment on reducing joint pain
Design
In this study, 86 patients with joint stiffness and entry conditions who are referred to the Hamza clinic are selected. The participants are randomly divided into intervention and control groups and assigned to each participant a code. Gets
Settings and conduct
Patients with joint stiffness are selected from Hamza Fasa Clinic And are divided into two groups of drugs and Control group.Patients and physicians are not known Type of medication
Participants/Inclusion and exclusion criteria
Entry requirements for patients with moderate to severe Joint stiffness aged 55-45 years.And the non-entry criteria for patients with other problems in the bones and joints.
Intervention groups
medicine، Dazan Handmade Ointment
Control group، Pyroxi com Ointment
Main outcome variables
The amount of pain
Dryness of the joint
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170520034042N1
Registration date:2017-12-28, 1396/10/07
Registration timing:registered_while_recruiting
Last update:2017-12-28, 1396/10/07
Update count:0
Registration date
2017-12-28, 1396/10/07
Registrant information
Name
Laleh Keihanpoor
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 5336 3741
Email address
l.keihanpoor@fums.ac.ir
Recruitment status
Recruitment complete
Funding source
Fasa university of Medical Sciences
Expected recruitment start date
2017-12-22, 1396/10/01
Expected recruitment end date
2018-03-11, 1396/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessement of DaZan herbal combination and piroxicam on the os pain as ointment dosage form
Public title
effect of DaZan herbal combination-on the os pain as ointment dosage form
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with moderate to severe joint stiffness
Age 45-55
Exclusion criteria:
Having other knee pain types
Having surgery or knee injury history
Hip and leg problems
Having a history of leg fracture
Having skin problems
Having peripheral vascular diseases
Any disability in the upper limbs that disrupts
Patients who have had intra-articular corticosteroid injection
Age
From 45 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
86
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is based on the random number generated by the computer and on the AB and BA permutation axis.
Blinding (investigator's opinion)
Double blinded
Blinding description
Medications and medicines are designed in a completely identical package.Since the medicine after Prescribing by Medical Officer is available sick the doctor Will not be notified Type of medication
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Fasa university of Medical Sciences
Street address
Fasa university of Medical Sciences,Ebne sina square,Fasa,Fars
City
Fasa
Province
Fars
Postal code
7461686688
Approval date
2017-05-09, 1396/02/19
Ethics committee reference number
IR.FUMS.REC.1396.186
Health conditions studied
1
Description of health condition studied
Joint rubbing
ICD-10 code
M23
ICD-10 code description
Internal derangement of knee
Primary outcomes
1
Description
The joint pain
Timepoint
Before the start of the study،A week later, Les Start،Two week later, Les Start،A month later,les start
Method of measurement
Questionnaire
Secondary outcomes
1
Description
Joint stiffness
Timepoint
Before the start of the study،a week after of start،Two week after start،a month after of start
Method of measurement
Questionnaire
Intervention groups
1
Description
Drug group(Dazan Ointment)،for use requested of patients that Rub it Some medicine every night before bedtime on the knee.
Category
Treatment - Drugs
2
Description
Control group: Pyroxi com،،for use requested of patients that Rub it Some medicine every night before bedtime on the knee.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hamza Clinic
Full name of responsible person
Mahmodreza Sarikhani
Street address
Ibn Sina Square Fasa University of Medical Sciences
City
Fasa
Province
Fars
Postal code
7461686688
Phone
+98 71 5335 0994
Email
sarikhani.1365@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
معاونت پژوهشی دانشگاه علوم پزشکی فسا
Full name of responsible person
Zahra Bordbar
Street address
Fasa university of Medical Sciences,Ebne sina square,Fasa,Fars
City
Fasa
Province
Fars
Postal code
7461686688
Phone
+98 71 5336 3741
Email
l.keihanpoor2013@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
معاونت پژوهشی دانشگاه علوم پزشکی فسا
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
Fasa University of Medical Sciences
Full name of responsible person
Seyedamin Kouhpayeh
Position
Pharmacologist
Latest degree
Ph.D.
Other areas of specialty/work
Others
Street address
Fasa university of Medical Sciences,Ebne sina square,Fasa,Fars
City
Fasa
Province
Fars
Postal code
7461686688
Phone
+98 71 5331 6324
Fax
Email
kouhpayeha@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Mahmoodreza Sarikhani
Position
Orthopaedic Surgon
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Fasa university of Medical Sciences,Ebne sina square,Fasa,Fars
City
Fasa
Province
Fars
Postal code
7461686688
Phone
+98 71 5331 7094
Fax
Email
sarikhani.1365@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Laleh Keihanpoor
Position
Researcher
Latest degree
Master
Other areas of specialty/work
Others
Street address
Alley rayatpishe.Six meters Ave.Fajr Township
City
Fasa
Province
Fars
Postal code
7461455090
Phone
+98 71 5336 3741
Fax
Email
l.keihanpoor2013@gmail.com
Web page address
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