Protocol summary

Study aim
Reducing complications of NSAID use from traditional medicine in patients with knee arthritis.
Design
Patients receive 8 sessions of dry depression for 4 weeks, twice a week. In addition to the kneecap, lumbar lining specialists recommend the same sessions, which increases the effectiveness of the treatment. First, the lining of the waist region is carried out for 5 minutes by means of two glasses on both sides of the waist, followed by a complete knee joint wound for 10 minutes: (Vacuum: 100-200 mbar, intervals: 2 seconds, pulses: 30-50%) Meanwhile, for patients with an iprill, every 12 hours (in the morning one hour after breakfast and at night before bedtime), one person is prescribed.
Settings and conduct
The location of the study is the Traditional and Complementary Medicine Research Center (TCMRC)
Participants/Inclusion and exclusion criteria
Inclusion criteria 1. Genital: Male Weight 2.Sen: 40-80 years old Exit criteria: 1. Current use of anticoagulants or coagulopathy 2. Intradermal corticosteroid or NSAID intramuscular injection within 4 months
Intervention groups
Group 1: Recipient of Iarage Fighra Group 2: Recipient of dry cupping
Main outcome variables
Reducing pain,

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180617040114N1
Registration date: 2018-11-09, 1397/08/18
Registration timing: retrospective

Last update: 2018-11-09, 1397/08/18
Update count: 0
Registration date
2018-11-09, 1397/08/18
Registrant information
Name
jamal Amri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3417 3502
Email address
jamal.amri71@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-07, 1397/07/15
Expected recruitment end date
2019-01-20, 1397/10/30
Actual recruitment start date
2018-01-05, 1396/10/15
Actual recruitment end date
2018-08-20, 1397/05/29
Trial completion date
empty
Scientific title
Comparison of the effect of treatment with Iarage Fighra and pulsatile dry cupping in patients with knee osteoarthritis (Before and after treatment) :a randomized controlled exploratory trial
Public title
Traditional medicine and knee pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
VAS more than 40 mm During the last 4 weeks, the patient has not received any other treatment other than NSAID treatment Radiological classification according to Kellgren-Lawrence criteria: 2-4
Exclusion criteria:
Current use of anticoagulants or coagulopathy Systemic use of corticosteroid for 4 weeks Get Physical Medicine, Leech and Acupuncture Over the Last 4 Months
Age
From 40 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 64
Actual sample size reached: 50
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
The subjects of the two test groups did not know which group were assigned and the statistical information of the two groups with titles A and B was provided to the statistician. Therefore, the present study was a double-blind study.
Placebo
Not used
Assignment
Factorial
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
Arak, Sardasht, Basij Square, Arak University of Medical Sciences, Deputy of Research and Technology
City
arak
Province
Markazi
Postal code
3848176341
Approval date
2018-05-13, 1397/02/23
Ethics committee reference number
IR.ARAKMU.REC.1397.46

Health conditions studied

1

Description of health condition studied
Patients with knee osteoarthritis
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Reduce the side effects of taking NSAIDs
Timepoint
Daily
Method of measurement
The severity of pain is measured through the VAS from 0 to 10

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: All patients are male and female aged 40-80 with knee osteoarthritis
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Arak Kowsar Clinic
Full name of responsible person
Seyed Amir Hossein Latifi
Street address
Imam Khomeini street
City
arak
Province
Markazi
Postal code
381413634
Phone
+98 86 3223 3823
Email
tcmrc.2016@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Hasan Taher Ahmadi
Street address
Shahid Shiroodi Street, Alam al-Hoda St.
City
arak
Province
Markazi
Postal code
٣٨١٩٦٩٣٣٤٥
Phone
+98 86 3313 6055
Email
info@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Seyed Amir Hossein Latifi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Arak, Sardasht, Basij Square, Faculty of Medicine
City
Arak
Province
Markazi
Postal code
3848176341
Phone
+98 34173645086
Email
seiedalatifi@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Seyed Amir Hossein Latifi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Arak, Sardasht, Basij Square, Faculty of Medicine
City
arak
Province
Markazi
Postal code
3848176341
Phone
+98 34173645086
Email
seiedalatifi@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
jama amri
Position
Research Expert
Latest degree
Master
Other areas of specialty/work
Biochemistry
Street address
Arak, Sardasht, Basij Square, Faculty of Medicine
City
arak
Province
Markazi
Postal code
3848176341
Phone
+98 34173645086
Email
jamal.amri71@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
For possible reasons, participants do not agree to publish their information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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