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IRCT20220411054495N1 IRCT 2022-04-17 Gorgan University of Medical Sciences Evaluation of iontophoretic effects of kimiainca gel on patients with Knee Osteoarthritis clinical trial study of iontophoretic effects of kimiainca gel on patients with Knee Osteoarthritis in 2022: pilot study 2022-06-22 anticipated 45 Complete https://irct.ir/trial/62868 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, 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 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. 3 osteoarthritis. Intervention 1: 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. Intervention 2: 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. Intervention 3: 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. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no more information
public Dr. Vahid Khori
shastkola Road
Gorgan Iran (Islamic Republic of) ۷۴۵۱۵ ۴۹۳۴۱ +98 17 3245 1434 vaph99@yahoo.com Gorgan University of Medical Sciences scientific Dr. Vahid Khori
shastkola Road
Gorgan Iran (Islamic Republic of) ۷۴۵۱۵ ۴۹۳۴۱ +98 17 3245 1434 vaph99@yahoo.com Gorgan University of Medical Sciences Iran (Islamic Republic of) 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 45 years 75 years Both 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 M15.9 Polyosteoarthritis, unspecified Treatment - Drugs Treatment - Drugs Placebo 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. 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 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. Pain. Timepoint: Before and after intervention. Method of measurement: KOOS questionnaire (Knee Injury and Osteoarthritis Outcome Score). Blood pressure. Timepoint: Before and after intervention. Method of measurement: Mercury sphygmomanometer. CRP Test (C-Reactive Protein ). Timepoint: Before and after intervention. Method of measurement: Blood test. Gorgan University of Medical Sciences Approved 2022-02-06 Ethics committee of Golestan University of Medical Sciences School of Medicine, Golestan University of Medical Sciences, Gorgan, Iran Gorgan Golestan Iran (Islamic Republic of)