Evaluation of the effect of "Arthroheal" Lipogel Herbal Medicine on Osteoarthrit Patients
Design
This study will be a double blind, prospective, randomized and comparative study. Seventy female and male patients will be selected from the rheumatology clinic of Mazandaran University of Medical Sciences and randomly divided into two groups, Lipogel The placebo group is divided into two groups, the second group taking lipogel containing the extract. To randomize the patients, we divided the patients into two groups according to the order of attendance at the numbering clinic and by random number table. Both groups are allowed to use Nsaid for ethics.
Settings and conduct
The study does under the supervision of a Rheumatologist at touba medical center . The randomized coded products are given to patients.
Participants/Inclusion and exclusion criteria
Men and women over 40 years of age with knee Osteoarthritis grade 1 and 2 based on x-ray, no previous history of OA, at least one month interval with latest intra-articular injection and no intra-articular injection during the study, no Lumbar Neurological disorder, no peripheral Neuropathy, no grade 3 and 4 Heart failure, no need for Diabetic dialysis
Intervention groups
The study included two intervention and control groups. The intervention group received lipogel containing extract twice a day and five times daily and the control group received placebo twice daily and five times daily.
Main outcome variables
Evaluation of pain relief in consumer patients
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130911014630N9
Registration date:2020-05-04, 1399/02/15
Registration timing:registered_while_recruiting
Last update:2020-05-04, 1399/02/15
Update count:0
Registration date
2020-05-04, 1399/02/15
Registrant information
Name
Mohammad Azadbakht
Name of organization / entity
Mazandaran University of Medical Scinecee
Country
Iran (Islamic Republic of)
Phone
+98 11 3354 3728
Email address
mazadbakht@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-21, 1397/01/01
Expected recruitment end date
2020-05-21, 1399/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of "Arthroheal" Lipogel Herbal Medicine on Osteoarthrit Patients
Public title
Evaluation of the effect of "Arthroheal" Lipogel Herbal Medicine on Osteoarthrit Patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Men and Women Over the Age of Forty years with Osteoarthritis in the Knee Area with Grade 1 and 2
No Previous Surgery History for Osteoarthritis
An interval at Least one Month with the Latest Intra-Articular Injection and no Intra-Articular Injection During the Study
Exclusion criteria:
Age less than a quarter of a year
Diagnosis of Rheumatoid Arthritis
Neurological Disorder of the Waist
Peripheral Neuropathy
Patient with Grade 3 and Grade 4 Heart Failure
Diabetic Patient Undergoing Dialysis
Malignant Patient
Intra-articular Injection at Intervals of less than One Month or During the Study
Age
From 40 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
70
More than 1 sample in each individual
Number of samples in each individual:
3
Three Number per Person according to Tube Volume
Randomization (investigator's opinion)
Randomized
Randomization description
On the First Day, Patients are Randomly Assigned to two Groups based on the number of Attending the Numbered Clinic.
Blinding (investigator's opinion)
Double blinded
Blinding description
Local Combination Gel and Placebo with 4-digit and Different Letter Codes and with the same Appearance At the Center for Clinical Evaluation, under
the Supervision of a Specialist in Rheumatology and Orthopedics, Patients are provided.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mazandaran University of Medical Sciences
Street address
Prophet Mohammad Medical Sciences Complex.Farahabad Street
City
Sari
Province
Mazandaran
Postal code
48188-69378
Approval date
2020-01-01, 1398/10/11
Ethics committee reference number
IR.MAZUMS.REC.1398.1285
Health conditions studied
1
Description of health condition studied
Osteoarthrit
ICD-10 code
M17
ICD-10 code description
Osteoarthritis of Knee
Primary outcomes
1
Description
Womac Questionnaire Score
Timepoint
First Day, Fourteen and Sixty
Method of measurement
Womac Questionnaire Score
Secondary outcomes
1
Description
VAS (Visual Analogue Scale) Questionaries
Timepoint
First day, Fourteen, Sixty
Method of measurement
VAS (Visual Analogue Scale) Questionaries
Intervention groups
1
Description
Intervention Group 1: Female or General Patient with Knee Osteoarthritis 1 and 2 According to Radiography with Daily Administration of 5 g of Lipogel Containing Drug for Two Months.The Patient is Allowed to Take Nsaid.
Category
Rehabilitation
2
Description
Control group 1: Female or general patient with knee osteoarthritis 1 and 2 according to radiography with 5 g daily of placebo for two months.The patient is allowed to take Nsaid.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Baghban's Specialized and Superior Specialized Slinic
Full name of responsible person
Maryam Mobini
Street address
Farah Abad Square،Khazar Boulevard
City
Sari
Province
Mazandaran
Postal code
48188-69378
Phone
+98 11 3324 0002
Email
Azadbakhtm@hotmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Mohammad Azadbakht
Street address
Farah abad street
City
Sari
Province
Mazandaran
Postal code
4847191971
Phone
+98 11 3354 2472
Fax
Email
Azadbakhtm@hotmail.com
Grant name
.
Grant code / Reference number
.
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Mahnaz Siri
Position
Pharmacy student of Sari School of Pharmacy
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
Farah Abad Street
City
Sari
Province
Mazandaran
Postal code
.
Phone
+98 51 3213 2065
Email
Mahnazshiri713@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Mohamad Azadbakht
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Farah Abad Street
City
Sari
Province
Mazandaran
Postal code
6937848188
Phone
+98 911 151 3032
Email
Azadbakhtm@hotmail.com
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Mahnaz Shiri
Position
Pharmacy Student
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
Farah Abad Street
City
Sari
Province
Mazandaran
Postal code
48188-69378
Phone
+98 51 3213 2065
Email
Mahnaz.shiri713@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Results from clinical trials
When the data will become available and for how long
Start access after printing the article
To whom data/document is available
Access for scholars working in academic institutions
Under which criteria data/document could be used
Use of results is allowed only by mentioning its source
From where data/document is obtainable
azadbakhtm@hotmail.com
What processes are involved for a request to access data/document