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IRCT20240726062545N1 IRCT 2024-08-03 Yazd University of Medical Sciences Investigating the effect of extract of rosa canina fruit on orthostatic hypotension Investigating the effect of extract of rosa canina fruit on orthostatic hypotension in people with type 2 diabetes 2024-09-05 anticipated 60 Complete https://irct.ir/trial/78234 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, one of the groups is denoted by the letter A and the other group by the letter B. Then, the random allocation list is prepared by using the simple randomization method and through the Random allocation software version 2.0 by the statistical consultant. In this way, it is determined which of the types of drug packages each patient will receive based on the order of entry into the study(A or B). The drug and placebo are packed in similar containers by the drug supplier and labeled with the letters A and B. Which letter indicates which intervention is determined by the drug supplier during labeling, and Until the completion of the study, no one other than her/him will be informed about this issue, Blinding description: Patient: Capsules containing medicine and placebo are completely similar in terms of shape, color and packaging. Due to the fact that rosa canina has a pleasant smell and the drug and placebo can be distinguished by the smell, so somerosa canina essential oil will be added to the content of the placebo so that they are almost similar in smell. Principal Investigator: The concerned resident will receive identical sealed medication packages marked with the letter A or B and will not be informed of which drug/placebo is contained in each medication package. Statistical consultant: She prepares the randomization list for two letters A and B, but she will not know which letter represents the intervention and which represents the control. 3 orthostatic hypotension. Intervention 1: Intervention group: In addition to health recommendations such as drinking large amounts of fluids and increasing salt intake and following a diet, a 500 mg capsule containing water extract powder of Rosa canina with ID (voucher number I.SE.009), which is prepared as a capsule It is prepared from a pharmaceutical company affiliated with the Hellal Ahmar , it is used twice a day for 4 weeks. The standardization of the drug is based on total polyphenol as gallic acid. Intervention 2: Control group: In addition to health recommendations, such as drinking large amounts of fluids and increasing salt intake and following a diet, 500 mg placebo capsules containing starch powder and 1% Rosa canina essential oil are used every 12 hours for a month. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Morvarid Salamati
Ebn Sina Blvd, Shahid Sadoughi Hospital
Yazd Iran (Islamic Republic of) 8915887857 0003538224000 m.salamati78@gmail.com Yazd University of Medical Sciences scientific Morvarid Salamati
Ebn Sina Blvd, Shahid Sadoughi Hospital
Yazd Iran (Islamic Republic of) 8915887857 000353822400 m.salamati78@ gmail.com Yazd University of Medical Sciences Iran (Islamic Republic of) Age above 18 years Suffering from type 2 diabetes Suffering from orthostatic hypotension based on internal specialist's diagnosis 18 years no limit Both Recent stroke or heart attack Having heart rhythm disorders uncontrolled blood pressure end-stage renal disease (ESRD) neuromuscular disease heart failure (CHF) HA1C level greater than 9 GFR less than 30 People who are treated with prazosin and tamsulosin I95.1 Orthostatic hypotension Treatment - Drugs Placebo Intervention group: In addition to health recommendations such as drinking large amounts of fluids and increasing salt intake and following a diet, a 500 mg capsule containing water extract powder of Rosa canina with ID (voucher number I.SE.009), which is prepared as a capsule It is prepared from a pharmaceutical company affiliated with the Hellal Ahmar , it is used twice a day for 4 weeks. The standardization of the drug is based on total polyphenol as gallic acid. Control group: In addition to health recommendations, such as drinking large amounts of fluids and increasing salt intake and following a diet, 500 mg placebo capsules containing starch powder and 1% Rosa canina essential oil are used every 12 hours for a month. Orthostatic hypotension. Timepoint: Measurement of orthostatic hypotension at the beginning of the study and one month after the consumption of the rosa canina extract. Method of measurement: Use of sphygmomanometer. Orthostatic Intolerance* Questionnaire (OIQ) score. Timepoint: Measurement of Orthostatic Intolerance* Questionnaire (OIQ) score at the beginning of the study and one month after consumption of Rosa canina extract. Method of measurement: Orthostatic Intolerance* Questionnaire (OIQ). Yazd University of Medical Sciences Approved 2024-07-06 Research Ethics commitee of School of Medicine -Shahid Sadoughi University of Medical Sciences Ebne sina Blvd ,Shahid Sadoughi Hospital Yazd Yazd Iran (Islamic Republic of)