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IRCT20220403054396N1 IRCT 2023-03-24 Vice Chancellery of Technology And Research of Birjand University of Medical Sciences The effect of tarragon oil on the intensity of pain, dryness and physical function of the knee in people with chronic osteoarthritis The effect of tarragon oil on the intensity of pain, dryness and physical function of the knee in people with chronic osteoarthritis. 2023-04-04 anticipated 90 Complete https://irct.ir/trial/65857 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Other, Purpose: Supportive, Randomization description: Patients will be divided into three intervention groups (local use of tarragon oil), sesame oil group, and control group, using six permutation blocks that will be generated by Random allocation software. In this way, the selection pattern of patients in three groups is determined. And the type of treatment for each participant will be determined in this way. Then the researcher will explain to the patients how to study and the details of the intervention, Blinding description: This study will be one-sided blind. In this way, the participants will be unaware of the intervention groups and the type of interventions in the other groups and will only do the intervention that is intended for them upon entering one of the groups. N/A Knee osteoarthritis. Intervention 1: Intervention group: after explaining the objectives and method of the study to the research patients, if they are willing to cooperate and after obtaining informed consent, the patients will be divided into three intervention groups by using the permutation blocks of six that will be generated with the Random Allocation software. (local use of tarragon oil), the sesame oil group will be the control group. In this way, the selection pattern of patients in three groups is determined. And the type of treatment for each participant will be determined in this way. Then the researcher will explain how to study and the details of the intervention to the patients and explain the method of topical use of oil to each of them. The tarragon plant will first be identified and the corresponding herbarium will be prepared and kept in the Faculty of Pharmacy of Birjand University of Medical Sciences. The method of preparing tarragon oil based on similar articles will be as follows: first, tarragon essential oil will be extracted using Clevenger. The water extract remaining in the Kalunger balloon will be boiled with sesame oil (obtained from Barij Essan Pharmaceutical Company). In this method, water-soluble compounds such as polyphenols and flavonoids are introduced into the oil base. After removing water and remaining oil, essential oil is added to the prepared oil. This method will prevent the loss of volatile compounds. Analysis of tarragon essential oil will be done using a gas chromatograph. The microbial range of the oil is measured and determined based on the standard pharmaceutical pharmacopoeia. If there is a problem, it will be fixed and then he will enter the hospital. Oils will be poured into dark colored containers at the rate of 50 cc. After that, the researcher will give a bottle containing 50 cc of tarragon oil and a weekly schedule to each participant in the intervention group. The intervention group applied tarragon oil extract in the amount of 1.5 cc in the affected knee area three times a day, every other day for three weeks, in each of the internal, external, front and back directions of the affected knee so that the oil covers the entire skin of the area. will be used. Before use, the intervention group patients are asked to test the said oil on the inner part of the forearm to make sure there is no skin sensitivity. Also, the contact number of the researcher will be provided to the participants so that they can contact the researcher in case of any allergies or side effects. The study will be done in a certain season. In addition, the researcher will remind the participants through a phone call to remind them how and when to conduct the intervention. In addition, all participants will use the same conventional drugs, including NSAIDs, acetaminophen, etc., prescribed by a rheumatologist. During the study, patients are allowed to use less than 2 grams of acetaminophen tablets per day, and patients are asked to record their daily acetaminophen intake. And in the visits at the end of the first week and the last week, the researcher will record the number of pills taken. Evaluation of research variables and information will be collected using the WOMAC questionnaire at 4 time points. The first collection point is before the intervention, when the questionnaire is presented to the participants. The next time points for data collection are immediately, 1 week after the intervention and 3 weeks after the intervention, which will be completed by the researcher's phone calls with the participants. Intervention 2: Control group 1: This group does not receive any topical oil during the intervention. The study will be conducted in a specific season. In addition, all participants will use the same conventional drugs, including NSAIDs, acetaminophen, etc., prescribed by a rheumatologist. During the study, patients are allowed to use less than 2 grams of acetaminophen tablets per day, and patients are asked to record their daily acetaminophen intake. And in the visits at the end of the first week and the last week, the researcher will record the number of pills taken. Evaluation of research variables and information will be collected using the WOMAC questionnaire at 4 time points. The first collection point is before use, when the questionnaire is presented to the participants. The next time points are for data collection, immediately, 1 week and 3 weeks later, which will be completed by the researcher's phone calls with the participants. Intervention 3: Control group 2: Sesame oil as placebo as well as traditional oil base will be prepared from Barij Essan pharmaceutical company. The researcher will give a bottle containing 50 cc of sesame oil (similar to the bottle containing tarragon oil) and a weekly schedule to each participant in the placebo group. from a similar type of syringe or dropper) in the area of the affected knee three times a day, every other day for three weeks in each direction of the inside, outside, front and back of the affected knee so that the oil covers the entire skin of the area. will be used. Before use, the patients of this group are asked to test the said oil on the inner part of the forearm to make sure there is no skin sensitivity. Also, the contact number of the researcher will be provided to the participants so that they can contact the researcher in case of any allergies or side effects. Before use, patients are asked to test the mentioned oils on the inner part of the forearm to make sure there is no skin sensitivity. Also, the contact number of the researcher will be provided to the participants so that they can contact the researcher in case of any allergies or side effects. The study will be done in a certain season. In addition, the researcher will remind the participants through a phone call to remind them how and when to conduct the intervention. In addition, all participants will use the same conventional drugs, including NSAIDs, acetaminophen, etc., prescribed by a rheumatologist. During the study, patients are allowed to use less than 2 grams of acetaminophen tablets per day, and patients are asked to record their daily acetaminophen intake. And in the visits at the end of the first week and the last week, the researcher will record the number of pills taken. Evaluation of research variables and information will be collected using the WOMAC questionnaire at 4 time points. The first collection point is before the intervention, when the questionnaire is presented to the participants. The next time points for data collection are immediately, 1 week after the intervention and 3 weeks after the intervention, which will be completed by the researcher's phone calls with the participants. Yes - There is a plan to make this available What will be shared: Information on the main outcome will be available When: Access starts 6 months after the results are published To whom: researchers Conditions: . Where to obtain: farzane_shafiee97@yahoo.com How to obtain: . Comments:
public Farzane Shafiee
22 Imamat Street, 2 Marwarid Alley, No. 18
Birjand Iran (Islamic Republic of) 9718864548 +98 56 3241 8735 farzane_shafiee97@yahoo.com Birjand University of Medical Sciences scientific Zahra Yonesi
South Khorasan, Birjand, Ghaffari Street, Birjand University of Medical Sciences - Faculty of Nursing and Midwifery
Birjand Iran (Islamic Republic of) ۹۷۱۷۸۵۳۵۷۷ +98 56 3238 1400 unesi500@yahoo.com Birjand University of Medical Sciences Iran (Islamic Republic of) Confirmation of knee osteoarthritis by a rheumatologist Pain level based on WOMAC training (mild to moderate pain intensity) People who are able to understand the explanations and complete the interview Age 30-70 years Absence of cancer, pregnancy and blood clotting disease such as hemophilia Not having a wound above the knee joint No signs of acute infection in the knee joint No skin lesions in the knee area No knee replacement surgery or intra-articular steroid injection within 90 days before the study No history of allergic reaction to sesame oil or products derived from tarragon Absence of lower limb abnormalities 30 years 70 years Both Taking oral and topical steroids within 14 days, alcohol addiction and narcotic drugs Suffering from radiculopathy and neuropathy, patients with musculoskeletal diseases (including rheumatoid, arthritis, septic arthritis, metabolic arthritis, gout and fibromyalgia) Using more than 2 grams a day of acetaminophen or other painkillers such as injectable drugs or other drugs such as glucosamine and Chondroitin sulfate being admitted to the hospital Unwillingness to continue participating in the study Traveling and leaving treatment Allergic reaction to sesame oil or products derived from tarragon M17 Osteoarthritis of knee Rehabilitation Rehabilitation Rehabilitation Intervention group: after explaining the objectives and method of the study to the research patients, if they are willing to cooperate and after obtaining informed consent, the patients will be divided into three intervention groups by using the permutation blocks of six that will be generated with the Random Allocation software. (local use of tarragon oil), the sesame oil group will be the control group. In this way, the selection pattern of patients in three groups is determined. And the type of treatment for each participant will be determined in this way. Then the researcher will explain how to study and the details of the intervention to the patients and explain the method of topical use of oil to each of them. The tarragon plant will first be identified and the corresponding herbarium will be prepared and kept in the Faculty of Pharmacy of Birjand University of Medical Sciences. The method of preparing tarragon oil based on similar articles will be as follows: first, tarragon essential oil will be extracted using Clevenger. The water extract remaining in the Kalunger balloon will be boiled with sesame oil (obtained from Barij Essan Pharmaceutical Company). In this method, water-soluble compounds such as polyphenols and flavonoids are introduced into the oil base. After removing water and remaining oil, essential oil is added to the prepared oil. This method will prevent the loss of volatile compounds. Analysis of tarragon essential oil will be done using a gas chromatograph. The microbial range of the oil is measured and determined based on the standard pharmaceutical pharmacopoeia. If there is a problem, it will be fixed and then he will enter the hospital. Oils will be poured into dark colored containers at the rate of 50 cc. After that, the researcher will give a bottle containing 50 cc of tarragon oil and a weekly schedule to each participant in the intervention group. The intervention group applied tarragon oil extract in the amount of 1.5 cc in the affected knee area three times a day, every other day for three weeks, in each of the internal, external, front and back directions of the affected knee so that the oil covers the entire skin of the area. will be used. Before use, the intervention group patients are asked to test the said oil on the inner part of the forearm to make sure there is no skin sensitivity. Also, the contact number of the researcher will be provided to the participants so that they can contact the researcher in case of any allergies or side effects. The study will be done in a certain season. In addition, the researcher will remind the participants through a phone call to remind them how and when to conduct the intervention. In addition, all participants will use the same conventional drugs, including NSAIDs, acetaminophen, etc., prescribed by a rheumatologist. During the study, patients are allowed to use less than 2 grams of acetaminophen tablets per day, and patients are asked to record their daily acetaminophen intake. And in the visits at the end of the first week and the last week, the researcher will record the number of pills taken. Evaluation of research variables and information will be collected using the WOMAC questionnaire at 4 time points. The first collection point is before the intervention, when the questionnaire is presented to the participants. The next time points for data collection are immediately, 1 week after the intervention and 3 weeks after the intervention, which will be completed by the researcher's phone calls with the participants. Control group 1: This group does not receive any topical oil during the intervention. The study will be conducted in a specific season. In addition, all participants will use the same conventional drugs, including NSAIDs, acetaminophen, etc., prescribed by a rheumatologist. During the study, patients are allowed to use less than 2 grams of acetaminophen tablets per day, and patients are asked to record their daily acetaminophen intake. And in the visits at the end of the first week and the last week, the researcher will record the number of pills taken. Evaluation of research variables and information will be collected using the WOMAC questionnaire at 4 time points. The first collection point is before use, when the questionnaire is presented to the participants. The next time points are for data collection, immediately, 1 week and 3 weeks later, which will be completed by the researcher's phone calls with the participants. Control group 2: Sesame oil as placebo as well as traditional oil base will be prepared from Barij Essan pharmaceutical company. The researcher will give a bottle containing 50 cc of sesame oil (similar to the bottle containing tarragon oil) and a weekly schedule to each participant in the placebo group. from a similar type of syringe or dropper) in the area of the affected knee three times a day, every other day for three weeks in each direction of the inside, outside, front and back of the affected knee so that the oil covers the entire skin of the area. will be used. Before use, the patients of this group are asked to test the said oil on the inner part of the forearm to make sure there is no skin sensitivity. Also, the contact number of the researcher will be provided to the participants so that they can contact the researcher in case of any allergies or side effects. Before use, patients are asked to test the mentioned oils on the inner part of the forearm to make sure there is no skin sensitivity. Also, the contact number of the researcher will be provided to the participants so that they can contact the researcher in case of any allergies or side effects. The study will be done in a certain season. In addition, the researcher will remind the participants through a phone call to remind them how and when to conduct the intervention. In addition, all participants will use the same conventional drugs, including NSAIDs, acetaminophen, etc., prescribed by a rheumatologist. During the study, patients are allowed to use less than 2 grams of acetaminophen tablets per day, and patients are asked to record their daily acetaminophen intake. And in the visits at the end of the first week and the last week, the researcher will record the number of pills taken. Evaluation of research variables and information will be collected using the WOMAC questionnaire at 4 time points. The first collection point is before the intervention, when the questionnaire is presented to the participants. The next time points for data collection are immediately, 1 week after the intervention and 3 weeks after the intervention, which will be completed by the researcher's phone calls with the participants. Pain. Timepoint: before the start of the intervention and immediately after the intervention, one week later and Three weeks after the intervention. Method of measurement: Western Ontario and McMaster Universities Osteoarthritis questionnaire. Joint dryness. Timepoint: before the start of the intervention and immediately after the intervention, one week later and Three weeks after the intervention. Method of measurement: Western Ontario and McMaster Universities Osteoarthritis questionnaire. Physical performance. Timepoint: before the start of the intervention and immediately after the intervention, one week later and Three weeks after the intervention. Method of measurement: Western Ontario and McMaster Universities Osteoarthritis questionnaire. Vice Chancellery of Technology And Research of Birjand University of Medical Sciences Approved 2022-12-28 Ethics committee of Birjand University of Medical Sciences Ghaffari St., Birjand University of Medical Sciences, Research and Technology Vice-Chancellor birjand South Khorasan Iran (Islamic Republic of)