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IRCT20130418013058N14 IRCT 2019-09-15 Mashhad University of Medical Sciences Effect of Artichoke and lettuce seed on lipid profile Study of the effect of Artichoke and lettuce seed combined capsule on lipid profile in patients with hyperlipidemia 2018-12-01 anticipated 70 Complete https://irct.ir/trial/30413 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: A Code will be Randomly Assigned to Each Box by the Software.The Therapist will give it to the Patient Randomly without Knowledge of the Type of Medicine. Thus, the Nature of Each Code will be Unclear Until the Analysis of the Results, Blinding description: Artichoke and lettuce seed combined and Placebo Capsules will be Prepared with the Same Shape, Color and Weight and will be Placed in Cans with Completely the Same Uniform, Color and Shape that Coded. The Treating Physician, Researcher, and Patients will not be Aware of the Code Printed on the Container. 0 (exploratory trials) Hyperlipidemia. Intervention 1: Intervention group: Getting 2 combined capsule containing lettuce seed and artichoke extract per day for 12 weeks along with hyperlipidemia regimen. Intervention 2: Control group: Getting 2 capsule of placebo per day for 12 weeks along with a hyperlipidemia treatment regimen. Yes - There is a plan to make this available What will be shared: Only some parts of data after blinding the subjects can be shared by the request of applicant When: After publishing article will be accessible To whom: Researchers and subjects in scientific and academic institutions Conditions: After request and for scientific use as in published article can be used in scientific resources reports Where to obtain: corresponding author How to obtain: Sending request to corresponding author, evaluation and if it will be confirmed, sending data and evidences to applicant Comments:
public Dr. Seyed Ahmad Mohajeri
School of Pharmacy, Mashhad University of Medical Sciences, Vakil Abad Blvd., Mashhad
Mashhad Iran (Islamic Republic of) 9188617871 +98 51 3882 3251 mohajeria@mums.ac.ir Mashhad University of Medical Sciences scientific Dr. Seyed Ahmad Mohajeri
School of Pharmacy, Mashhad University of Medical Sciences, Vakil Abad Blvd., Mashhad
Mashhad Iran (Islamic Republic of) 9188617871 +98 51 3882 3251 Mohajeria@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Patients with hyperlipidemia with cholesterol ≥ 200 mg / dL; Triglyceride ≥ 200 mg / dL and LDL ≥ 100 mg / dL BMI between 19 and 30 kg / m 2 40 years 65 years Both Taking antioxidant supplements Taking anti-seizure drugs Diabetes Cancer Hypothyroidism Menopause and pregnancy Smoking and alcohol Cases of chronic liver disease (Fatty liver, Cirrhosis, Hepatitis, etc.) E78.0 Pure hypercholesterolemia Treatment - Drugs Placebo Intervention group: Getting 2 combined capsule containing lettuce seed and artichoke extract per day for 12 weeks along with hyperlipidemia regimen Control group: Getting 2 capsule of placebo per day for 12 weeks along with a hyperlipidemia treatment regimen Lipid profile. Timepoint: Measurement of lipid profile at the beginning of the study (before intervention) and 6 and 12 weeks after intervention. Method of measurement: Blood test. Probable side effects of the Artichoke and lettuce seed combined capsule. Timepoint: 6 and 12 weeks after intervention. Method of measurement: reporting by patients. Mashhad University of Medical Sciences Approved 2018-05-19 Ethics comittee of Mashhad university of Medical science Deputy of Science and Technology, Mashhad University of Medical Sciences, next to the Hoveizeh cinema, Daneshgah Avenue Mashhad Razavi Khorasan Iran (Islamic Republic of)