]>
IRCT20211017052785N1 IRCT 2022-03-26 Karaj University of Medical Sciences Evaluating the effectiveness of Rosa canina L. fruit syrup on hypertension, cholesterol and anxiety In patients with hypertension Evaluating the effectiveness of Rosa canina L. fruit syrup on hypertension, cholesterol and anxiety In patients with hypertension A double-blind randomized clinical trial 2022-07-06 anticipated 80 Complete https://irct.ir/trial/62432 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants are divided into two groups by stratified block randomization, one group receives medication and the other receives placebo.Patients (after completing the lifestyle questionnaire and excluding people who receive the upper or lower third of the score) are divided into six groups based on the score of the lifestyle questionnaire, and each of them by designing 4 blocks and selecting blocks through the lottery, they receive one of two drug or placebo options, respectively, based on the block plan, Blinding description: The drugs used in the present study were prepared by the second executor, which has nothing to do with sampling and prescribing drugs. It is prepared in anonymous packs and given to the researcher. The contents of the packs remain completely confidential and will only be available to the drug manufacturer. The name of the medicine will be given to the personnel when the side effects of the medicine occur. The placebo is prepared by considering the necessary standards in color, smell, taste, shape, etc. 2 HTN. Intervention 1: Intervention group: To prepare Rosa syrup (according to USP 39 – NF 34, Second Supplement Commentary, June 1, 2016): 100 grams of washed Nastaran fruit soaked in 1000 cc of water, after 3 hours, boiled for 10 minutes and cooled in the laboratory. After cooling, we filter the contents of the container with a filter and concentrate the obtained product using a benmary. From 100 grams of Nastaran fruit, 8 grams of dry extract obtained from the extract obtained, 5 grams of it are brought to 100 grams using USP syrup making model with 7.66 grams of honey and 28.5 grams of water. The resulting syrup is poured into 120 cc sterile jars and sealed and sterilized by autoclave. The designed label is then installed and delivered for clinical trial. The raw materials of the medicine are prepared from reliable sources and the initial evaluation of its quality is done. Intervention 2: Control group: Placebo is prepared by considering the necessary standards in color, smell, taste, shape, etc. It will be consumed at a rate of 10cc once a day, half an hour before lunch and for a period of eight weeks. Yes - There is a plan to make this available What will be shared: Part of the data, such as information about the main consequences, can be shared by inserting it in the study article. When: Access period starts 8 months after the results are published To whom: Only for researchers working in academic and scientific institutions Conditions: Using data to advance scientific goals Where to obtain: Dr. Maarefvand dr.m.maarefvand@gmail.com How to obtain: Send the request for information via the announced gmail and the party will receive a response within a maximum of two weeks. Comments:
public Dr. Mina Maarefvand
45 meters from Golshahr - Saffarian Alley - Deputy of Research and Technology
Karaj Iran (Islamic Republic of) 3198764653 +98 26 3464 3774 dr.m.maarefvand@gmail.com Karaj University of Medical Sciences scientific Dr. Mina Maarefvand
45 meters from Golshahr - Saffarian Alley - Deputy of Research and Technology
Karaj Iran (Islamic Republic of) 3198764653 +98 26 3464 3705 dr.m.maarefvand@gmail.com Karaj University of Medical Sciences Iran (Islamic Republic of) Men and women in the age of 35 to 65 years with high blood pressure Systolic blood pressure greater than or equal to 130 to 159 and diastolic blood pressure greater than or equal to 85 to 99 mm Hg 35 years 65 years Both Pregnant and lactating women Patients with high normal blood pressure and grade 1 who have cardiovascular disease, especially coronary artery disease or grade 4 kidney failure or diabetes that leads to organ damage or grade 1 with chronic kidney failure grade 3 or diabetes without organ damage or organ damage due to high blood pressure The above is already specified in them. G6PD, hemochromatosis Taking medications such as warfarin, aspirin and lithium I10 Essential (primary) hypertension Treatment - Drugs Placebo Intervention group: To prepare Rosa syrup (according to USP 39 – NF 34, Second Supplement Commentary, June 1, 2016): 100 grams of washed Nastaran fruit soaked in 1000 cc of water, after 3 hours, boiled for 10 minutes and cooled in the laboratory. After cooling, we filter the contents of the container with a filter and concentrate the obtained product using a benmary. From 100 grams of Nastaran fruit, 8 grams of dry extract obtained from the extract obtained, 5 grams of it are brought to 100 grams using USP syrup making model with 7.66 grams of honey and 28.5 grams of water. The resulting syrup is poured into 120 cc sterile jars and sealed and sterilized by autoclave. The designed label is then installed and delivered for clinical trial. The raw materials of the medicine are prepared from reliable sources and the initial evaluation of its quality is done. Control group: Placebo is prepared by considering the necessary standards in color, smell, taste, shape, etc. It will be consumed at a rate of 10cc once a day, half an hour before lunch and for a period of eight weeks. Systolic and diastolic blood pressure. Timepoint: First visit and then every two weeks until the eighth week. Method of measurement: Digital sphygmomanometer. Blood HDL and LDL levels. Timepoint: Beginning and end of the trial. Method of measurement: Laboratory experiment. Severity of anxiety. Timepoint: Beginning and end of the trial. Method of measurement: Hamilton anxiety questionnaire. Karaj University of Medical Sciences Approved 2022-02-26 Ethics committee of Alborz University of Medical Sciences 45 meters from Golshahr - Saffarian Alley - Deputy of Research and Technology Karaj Alborz Iran (Islamic Republic of)