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IRCT20150711023153N5 IRCT 2023-12-06 Yasouj University of Medical Sciences The effect of sumac and cinnamon on cardiovascular patients The effect of sumac and cinnamon on lipid profile and quality of life in patients with cardiovascular diseases, a randomized double-blind controlled clinical trial. 2024-04-20 anticipated 75 Complete https://irct.ir/trial/70581 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Patients will be stratify by Block Random sampling based on age and sex in one of 12 blocks of 6 and 7 people and by random numbers from a website (Randomization.com) in one of three Sumac or Sumac and cinnamon or placebo groups, this list is in the hands of the group's secretary and Who Does not play a role in the study, Blinding description: Patients, health personnel, main researchers, as well as those responsible for data collection and analysis will be unaware of the intervention and placebo groups until the end of the study. The intervention consists of placebo or sumac or sumac and cinnamon in special capsules that are completely similar in terms of shape and color and are placed in numbered packages, and the contents of these numbers will be kept in closed envelopes in the faculty, and the contents will be preserved until the end of the study. N/A Cardiovascular diseases (CVDs). Intervention 1: First intervention group: patients receiving 2 grams of sumac daily in 2 doses (1 gram capsules containing sumac). Intervention 2: Second intervention group: patients receiving daily 1 gram of sumac and 1 gram of cinnamon in 2 doses (1 gram capsules containing 0.5 grams of sumac and 0.5 grams of cinnamon). Intervention 3: Control group: patients receiving 1 gram placebo capsules (Cellulose) on 2 occasions. Yes - There is a plan to make this available What will be shared: Data on primary variables will be shareable after de-identifying individuals. When: The access period starts 6 months after the results are published. To whom: The data will only be available to researchers working in academic and scientific institutions. Conditions: The data will only be available to researchers working in academic and scientific institutions Where to obtain: Seyed Bahman Panahande, Yasuj University of Medical Sciences, Yasuj, Iran. Email: panahande.b@gmail.com P.O. Box 7591741417, Tel:+98- 074-33346078, Fax:+98- 074-33346079, How to obtain: After receiving approval from Yasuj University of Medical Sciences (one week to one month), the data will be sent to the applicant Comments:
public Ashkan Golmohammadi
Chaharbagh Payin, 33 Alley, No. 5
Isfahan Iran (Islamic Republic of) 8148635756 +98 31 3448 5149 ashkan.gol79@hotmail.com Yasouj University of Medical Sciences scientific Seyed Bahman Panahande
Imam Hossein Square - Golestan 15, Faculty of Health and Nutrition
Yasuj Iran (Islamic Republic of) 7591875114 +98 74 3322 5519 panahande.b@gmail.com Yasouj University of Medical Sciences Iran (Islamic Republic of) Completing and signing the informed consent form. Age between 20-75 years Patients hospitalized in the cardiac intensive care unit who have MI (myocardial infarction) based on a definitive diagnosis. Type 2 diabetes mellitus diagnosed by a doctor Body mass index (BMI)>25 Familiarity with Persian language and the ability to read and write 20 years 75 years Both Pregnant and lactating people or people with mental illnesses, as well as patients with stomach ulcers or digestive disorders or other disorders affecting food metabolism. hypothyroidism or hyperthyroidism and any systemic disease (including liver, kidney, gout, rheumatoid arthritis and acute or chronic kidney failure) Allergy to sumac or cinnamon Users of psychotropic drugs, including antidepressants, anti-psychotics, anti-anxiety drugs Heart failure in stage IV Acute infections at the time of study entry Obstructive pulmonary diseases Treatment with sex hormones Use of medication interfering with the study Participation in another clinical study in the last 3 months People with any problems in understanding and filling the consent form I51.6 Cardiovascular disease, unspecified N/A N/A N/A First intervention group: patients receiving 2 grams of sumac daily in 2 doses (1 gram capsules containing sumac). Second intervention group: patients receiving daily 1 gram of sumac and 1 gram of cinnamon in 2 doses (1 gram capsules containing 0.5 grams of sumac and 0.5 grams of cinnamon) Control group: patients receiving 1 gram placebo capsules (Cellulose) on 2 occasions Low-density lipoprotein. Timepoint: At the beginning and end of the intervention period. Method of measurement: Laboratory methods. High-density lipoprotein. Timepoint: At the beginning and end of the intervention period. Method of measurement: Laboratory methods - Elisa Kit. Very-low density lipoprotein. Timepoint: At the beginning and end of the intervention period. Method of measurement: Laboratory methods. Triglyceride. Timepoint: At the beginning and end of the intervention period. Method of measurement: Laboratory methods - Elisa Kit. Total Cholesterol. Timepoint: At the beginning and end of the intervention period. Method of measurement: Laboratory methods - Elisa Kit. Life Quality. Timepoint: At the beginning and end of the intervention period. Method of measurement: World Health Organization quality of life questionnaire bref. Pain. Timepoint: At the beginning and end of the intervention period. Method of measurement: Mcgill pain questionnarie. Interleukin-6. Timepoint: At the beginning and end of the intervention period. Method of measurement: Laboratory methods. High sensitive C reactive protein (hs-CRP). Timepoint: At the beginning and end of the intervention period. Method of measurement: Laboratory methods. Complete blood count. Timepoint: At the beginning and end of the intervention period. Method of measurement: Laboratory methods. Yasouj University of Medical Sciences Approved 2023-06-10 Research Ethics Committees of Yasuj University of Medical Science Shahid Motahari Boulevard, Yasouj University of Medical Sciences Yasuj Kohgilouyeh-va-Boyrahmad Iran (Islamic Republic of)