Evaluation of iontophoretic effects of kimiainca gel on patients with Knee Osteoarthritis
Design
Two arm parallel groups randomized trial with blinded postoperative care and outcome assessment
Settings and conduct
Patients with osteoarthritis referred to the clinic of Sayad Shirazi Medical Center of Golestan University of Medical Sciences, patients aged 45 to 75 years will be randomly assigned to one of the experimental groups, double-blind, placebo-controlled. This study was performed on 45 patients with a diagnosis of osteoarthritis of the knee who were voluntarily and randomly divided into 3 groups of 15 for 6 sessions for two weeks.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Diagnosis of osteoarthritis of the knee based on examination by a specialist
Age between 45 and 75
male or female
Voluntary participation and written consent
exclusion criteria: Existence of telofemoral or hip osteoarthritis,
history of any knee fracture or surgery
history of inflammatory joint disease
history of intra-articular injection during the last six months
regular use of steroidal and non-steroidal anti-inflammatory drugs and anti-inflammatory drugs
during the previous two months
Intervention groups
Group 1: treated with iontophoresis and placebo gel (n = 15) (control group)
Group 2: treated with iontophoresis and chimeranica gel (containing a mixture of plant extracts) (n = 15)
Group 3: Treated with chimarnica gel and placement of electrode without iontophoresis in topical application (n = 15)
Main outcome variables
pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220411054495N1
Registration date:2022-04-17, 1401/01/28
Registration timing:prospective
Last update:2022-04-17, 1401/01/28
Update count:0
Registration date
2022-04-17, 1401/01/28
Registrant information
Name
hassan mirzaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 17 3245 1434
Email address
mirzaei22@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-06-22, 1401/04/01
Expected recruitment end date
2023-06-22, 1402/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
clinical trial study of iontophoretic effects of kimiainca gel on patients with Knee Osteoarthritis in 2022: pilot study
Public title
Evaluation of iontophoretic effects of kimiainca gel on patients with Knee Osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of osteoarthritis of the knee based on examination by a specialist
Age between 45 and 75
male or female
Voluntary participation and written consent
Exclusion criteria:
Existence of telofemoral or hip osteoarthritis,
history of any knee fracture or surgery
history of inflammatory joint disease
history of intra-articular injection during the last six months
regular use of steroidal and non-steroidal anti-inflammatory drugs and anti-inflammatory drugs during the previous two months
Age
From 45 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
The random assignment list will be computer generated with a 1:1 allocation, stratified by recruitment site, using a random block size of four. Using concealed in sequentially numbered, sealed, opaque envelopes (SNOSE), participants will enter the blocks in such a way that an equal number of each assigned group. Allocation will be done by randomly selecting one of the
arrangements and assigning the next part of the participants to the study groups according to the specified sequence. And kept by the hospital pharmacist of the center
Blinding (investigator's opinion)
Double blinded
Blinding description
To maintain blindness in patients, the drug and placebo are the same in shape and appearance. Also, the evaluator is not aware of the type of drugs in the intervention groups, so that multi-digit numerical codes are written on the drug packages that only the main person in charge of the research is aware of.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Golestan University of Medical Sciences
Street address
School of Medicine, Golestan University of Medical Sciences, Gorgan, Iran
City
Gorgan
Province
Golestan
Postal code
۷۴۵۱۵ ۴۹۳۴۱
Approval date
2022-02-06, 1400/11/17
Ethics committee reference number
IR.GOUMS.REC.1401.003
Health conditions studied
1
Description of health condition studied
osteoarthritis
ICD-10 code
M15.9
ICD-10 code description
Polyosteoarthritis, unspecified
Primary outcomes
1
Description
pain
Timepoint
Before and after intervention
Method of measurement
KOOS questionnaire (Knee Injury and Osteoarthritis Outcome Score)
Secondary outcomes
1
Description
blood pressure
Timepoint
Before and after intervention
Method of measurement
Mercury sphygmomanometer
2
Description
CRP Test (C-Reactive Protein )
Timepoint
Before and after intervention
Method of measurement
Blood test
Intervention groups
1
Description
Intervention group: Treated with iontophoresis and Kimiarnika gel (containing a mixture of plant extracts) (n = 15) Intervention group: treated with iontophoresis and chimiarnica gel (containing a mixture of plant extracts) (n = 15).in iontophoresis using galvanic current (low current and low voltage) can accelerate the penetration of the drug into the tissues. The ointment used in this combination is called Kimiarnica and all the mentioned compounds are according to the pharmacopoeia. All the ingredients used in this ointment are effective and have been used medicinally and have not had any side effects in clinical trials. These compounds are prepared by a reputable pharmaceutical factory and have the necessary and approved health licenses. Preparation formula for 1000 g = 200 g of marigold flower extract + 150 g of devil's claw extract + 150 g of ginger + + 100 g of capsaicin (pepper) + 150 g of nanocurcumin powder + 50 g of bee venom + 50 g of cannabidiol + base cream 150 g for Formulation The following steps are performed: The method of preparing the base The formulation is the method of melting. First, the semi-solid and solid materials that make up the base, which include Vaseline, etc., are melted and the temperature of the melt mixture is raised to 70 ° C and then, until it reaches stirring was continued at 40 °C. At this step, the effective compounds and concentrated extracts, which were semi-solid, were each geometrically separated from some of the base and added to the rest of the base. The mixing process continued until the product was uniformed and then the formulation was prepared. then packed into 15 g tubes. Then the uniformity and stability of the formulation against heat and cold as well as the study of the formulation in terms of pH changes are evaluated. How to intervene: First, to reduce skin resistance, the inside of the knee was washed with soap and water. In this group, while the cathode pole was placed on the inner part of the knee and the anode on the opposite side, the galvanic current was established for 20 minutes with an intensity of 5 mA. In the first group, after the gel was spread on the skin of the inner area of the knee, the cathode electrode was placed as the active pole on that area and the anode electrode was placed on the opposite side, and the facial treatment was performed for 20 minutes at 5 mA. The amount of drug used was large enough to cover the skin of the active electrode in a thin layer. Number of patients: 15 patients with osteoarthritis of the knee, in the age range of 45-75 years. Number of uses: 6 sessions Duration: 20 minutes to use: Topical Manufacturer: All compounds are used by reputable pharmaceutical companies and have the necessary and approved health licenses.
Category
Treatment - Drugs
2
Description
Intervention group: Kimiarnika gel and electrode placement without iontophoresis (n = 15). Intervention group: treated with iontophoresis and chimiarnica gel (containing a mixture of plant extracts) (n = 15).in iontophoresis using galvanic current (low current and low voltage) can accelerate the penetration of the drug into the tissues. The ointment used in this combination is called Kimiarnica and all the mentioned compounds are according to the pharmacopoeia. All the ingredients used in this ointment are effective and have been used medicinally and have not had any side effects in clinical trials. These compounds are prepared from a reputable pharmaceutical factory and have the necessary and approved health licenses. Preparation formula for 1000 g = 200 g of marigold flower extract + 150 g of devil's claw extract + 150 g of ginger + + 100 g of capsaicin (pepper) + 150 g of nanocurcumin powder + 50 g of bee venom + 50 g of cannabidiol + base cream 150 g for Formulation The following steps are performed: The method of preparing the base The formulation is the method of melting. First, the semi-solid and solid materials that make up the base, which include Vaseline, etc., are melted and the temperature of the melt mixture is raised to 70 °C and then, until it reaches stirring was continued at 40 °C. At this step, the effective compounds and concentrated extracts, which were semi-solid, were each geometrically separated with some of the base and added to the rest of the base. The mixing process continued until the product was uniformed and then the formulation was prepared. then packed in 15 g tubes. Then the uniformity and stability of the formulation against heat and cold as well as the study of the formulation in terms of pH changes are evaluated. How to intervene: First, to reduce skin resistance, the inside of the knee was washed with soap and water. In the second group, Kimiarnika gel was massaged on the skin of the inner part of the knee and then, as in the previous group, electrode was applied on the knee with the device on and without output for 20 minutes. The amount of drug used was large enough to cover the skin of the active electrode in a thin layer. Number of patients: 15 patients with osteoarthritis of the knee, in the age range of 45-75 years. Number of uses: 6 sessions Duration: 20 minutes How to use: Topical
Category
Treatment - Drugs
3
Description
Control group: Treated with iontophoresis and placebo gel (n = 15) In this method, iontophoresis with galvanic current (low current and low voltage) is used. Placebo gel with a combination of base cream and Vaseline is used. All the materials used in this gel are of medicinal type and have no side effects in clinical trials. These compounds are prepared by a reputable pharmaceutical factory and have the necessary and approved health licenses. How to intervene: First, to reduce skin resistance, the inside of the knee was washed with soap and water. In this group, while the cathode pole was placed on the inner part of the knee and the anode on the opposite side, the galvanic current was established for 20 minutes with an intensity of 5 MA. In the first group, after the placebo gel was spread on the skin of the inner area of the knee, the cathode electrode was placed as the active pole on that area and the anode electrode was placed in front of it and treated for 20 minutes at 5 mA. Took. The amount of drug used was large enough to cover the skin of the active electrode in a thin layer. All patients were treated for 6 sessions and in order to evaluate the effectiveness of each treatment method, in the two stages before and after 6 sessions of treatment (Knee injury and Osteoarthritis KOOS) outcome Score, which includes assessment of pain, joint dryness and function. Physical patients is used. Number of patients: 15 patients with osteoarthritis of the knee, in the age range of 45-75 years. Number of uses: 6 sessions. Duration: 20 minutes. How to use: Topical Manufacturer: All compounds from reputable pharmaceutical companies and have the necessary and approved health licenses is used.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Ischemic Disorders Research Center, Golestan University of Medical Sciences
Full name of responsible person
Dr. Vahid Khori
Street address
Shastkola Road
City
Gorgan
Province
Golestan
Postal code
۷۴۵۱۵ ۴۹۳۴۱
Phone
+98 17 3245 1434
Fax
+98 17 3245 1657
Email
mirzaei22@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Dr. Mohamad Reza Honarvar
Street address
shastkola Road
City
Gorgan
Province
Golestan
Postal code
۷۴۵۱۵ ۴۹۳۴۱
Phone
+98 17 3245 1434
Fax
+98 17 3245 1657
Email
mirzaei22@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gorgan 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
Gorgan University of Medical Sciences
Full name of responsible person
Dr. Vahid Khori
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
shastkola Road
City
Gorgan
Province
Golestan
Postal code
۷۴۵۱۵ ۴۹۳۴۱
Phone
+98 17 3245 1434
Fax
+98 17 3245 1657
Email
vaph99@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Dr. Vahid Khori
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
shastkola Road
City
Gorgan
Province
Golestan
Postal code
۷۴۵۱۵ ۴۹۳۴۱
Phone
+98 17 3245 1434
Fax
+98 17 3245 1657
Email
vaph99@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Hassan Mirzaei
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
School of Medicine, Golestan University of Medical Sciences, Gorgan, Iran
City
Gorgan
Province
Golestan
Postal code
۷۴۵۱۵ ۴۹۳۴۱
Phone
+98 17 3245 1434
Fax
+98 17 3245 1434
Email
mirzaei22@yahoo.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
There is no more information
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available