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IRCT20150721023282N7 IRCT 2020-01-03 Esfahan University of Medical Sciences Evaluation the effect of allium hirtifolium in the treatment of hyperlipidemia Evaluation the effect of allium hirtifolium on serum lipid profile in adult patients with hyperlipidemia 2018-11-22 anticipated 50 Complete https://irct.ir/trial/43356 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization: Blocks of 4 will be used and patients will be assigned to drug and placebo groups based on the determined sequences in the blocks, Blinding description: Drug and placebo capsules will be fully similar and packaged in similar containers. The patient, the prescriber (physician), data analyst, and the laboratory personnel will be blind to the content of containers and intervention type. 3 Hyperlipidemia. Intervention 1: Drug group: 500-mg oral capsules of Allium, twice daily, for 6 weeks. Intervention 2: Placebo group: 500-mg oral capsules of placebo, twice daily, for 6 weeks. No - There is not a plan to make this available Justification or reason for not sharing IPD is Confidentiality of patients data
public Rasool Soltani
No. 20, Bagh Daryacheh Ave.
Isfahan Iran (Islamic Republic of) 8176776161 +98 31 3786 5537 soltani@pharm.mui.ac.ir Esfahan University of Medical Sciences scientific Rasool Soltani
No. 20, Bagh Daryacheh Ave.
Isfahan Iran (Islamic Republic of) 8176776161 +98 31 3786 5537 soltani@pharm.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Age of more than 18 years Serum level of LDL between 100 to 160 mg/dL Having less than 2 cardiovascular risk factors 18 years no limit Both Cardiac stable angina Diabetes mellitus Diseases affecting level of serum lipids Use of drugs affecting level of serum lipids E78.5 Hyperlipidemia, unspecified Treatment - Drugs Placebo Drug group: 500-mg oral capsules of Allium, twice daily, for 6 weeks Placebo group: 500-mg oral capsules of placebo, twice daily, for 6 weeks Serum level of total cholesterol. Timepoint: Before the intervention and the end of intervention (6 weeks after the start of intervention). Method of measurement: Blood test. Serum level of triglycerides. Timepoint: Before the intervention and the end of intervention (6 weeks after the start of intervention). Method of measurement: Blood test. Serum level of LDL. Timepoint: Before the intervention and the end of intervention (6 weeks after the start of intervention). Method of measurement: Blood test. Serum level of HDL. Timepoint: Before the intervention and the end of intervention (6 weeks after the start of intervention). Method of measurement: Blood test. Esfahan University of Medical Sciences Approved 2019-07-31 Ethics committee of Isfahan University of Medical Sciences Hezar-Jerib Avenue, Vice-chancellery for research, Isfahan University of Medical Sciences, Isfahan Isfahan Isfehan Iran (Islamic Republic of)