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IRCT2015071314521N4 IRCT 2017-03-02 Mashhad University of Medical Sciences Curcumin and hypertriglyceridemia The effects of curcumin bergamot supplementation on fasting triglyceride levels in patients with hypertriglyceridemia taking statin: A randomized double-blind clinical trial 2022-05-04 anticipated 40 Complete https://irct.ir/trial/14138 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization is done individually. Entry of each patient into the intervention or control group is done randomly with the help of 4 blocking. This is done using a reputable random number generation website. (Random number generation website: https://www.sealedenvelope.com/simple-randomiser/v1/lists), Blinding description: The study will be double blinded so that the researcher and the subjects will not know which group they belong to. For blinding, curcumin bergamot and placebo capsules are prepared in the same shape, color, and size. These capsules are coded by someone other than the researchers (A and B) and then the capsules are given to patients. Until the end of the study and after analyzing the data, researchers will not know about the intervention and control groups. 2 Hypertriglyceridemia. Intervention 1: Intervention 1 The participants will be asked to take one capsule/day containing 100 mg curcuminoids and 200 mg bergamot, which was contained in an unlabeled for a period of 8 weeks. Intervention 2: Intervention 2 The placebo capsules containing lactose which will used orally for a period of 8 weeks. . Yes - There is a plan to make this available What will be shared: Study information will be published after the individuals are unidentified and after the project is completed. When: Access period starts six months after the results are published To whom: Researchers working in academic and scientific institutions Conditions: For further analysis Where to obtain: Amirhossein Sahebkar sahebkara@mums.ac.ir How to obtain: After reviewing the request and making it fully clear about the purposes of using the data, the data will be provided Comments:
public Amirhosein Sahebkar
Mashhad, Azadi square, Pardis of Ferdousi University, School of Medicine
Mashhad Iran (Islamic Republic of) 91779-48564 +98 51 3800 2288 sahebkara@mums.ac.ir Mashhad University of Medical Sciences scientific Amirhosein Sahebkar
School of Medicine, Pardis of Ferdousi University
Mashhad Iran (Islamic Republic of) 91779-48564 +98 51 3800 2288 sahebkara@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Age 18-65 years Fasting serum TG>150 mg/dl Using Statin drugs 18 years 65 years Both Unwillingness to participate in the study Sensitivity to herbal supplements E78.1 Pure hyperglyceridaemia Treatment - Drugs Placebo Intervention 1 The participants will be asked to take one capsule/day containing 100 mg curcuminoids and 200 mg bergamot, which was contained in an unlabeled for a period of 8 weeks. Intervention 2 The placebo capsules containing lactose which will used orally for a period of 8 weeks. . Triglycerides. Timepoint: before the intervention. Method of measurement: enzymatic experimental kit. FBG. Timepoint: 2 months after the intervention. Method of measurement: enzymatic experimental kit. Insulin. Timepoint: 2 months after the intervention. Method of measurement: radioimmunoassay experimental kit. Total cholesterol. Timepoint: 2 months after the intervention. Method of measurement: enzymatic experimental kit. HDL-C. Timepoint: 2 months after the intervention. Method of measurement: enzymatic experimental kit. LDL-C. Timepoint: 2 months after the intervention. Method of measurement: enzymatic experimental kit. HS-CRP. Timepoint: 2 months after the intervention. Method of measurement: ELISA experimental kit. Body mass index. Timepoint: 2 months after the intervention. Method of measurement: weight (kg) / height2 (m). Mashhad University of Medical Sciences Approved 2016-11-02 Ethics committee of Mashhad University of Medical Sciences Mashhad, Daneshgah Street, Ghoreishi Bilding Mashhad Razavi Khorasan Iran (Islamic Republic of)