Initial Evaluation of Effect of Internal Septum of Juglans regia L. on Blood Lipids in Patients with Dyslipidemia: A Double-blind Placebo-controlled Randomized Clinical Trial

Initial Evaluation of Effect of Internal Septum of Juglans regia L. on Blood Lipids in Patients with Dyslipidemia: A Double-blind Placebo-controlled Randomized Clinical Trial

Clinical trial with control group, parallel groups, double-blind, randomized, phase 3 on 60 patients.

In this study, patients are identified and monitored in the Endocrinology Clinic of Imam Khomeini Hospital in Tehran. Patients are divided into two groups by block randomization method and receive a capsule containing internal septum of Juglans regia L. or placebo 3 times a day for 12 weeks. Patients receive their anti dyslipidemia drugs during the study. In this study, the researcher and patients are blind.

Inclusion criteria: Obtain informed consent from patients. Patients aged 25 to 70 years. Patients with dyslipidemia who have serum low density lipoprotein cholesterol more than goal based on European Heart Association 2019 guideline despite receiving the maximum or maximum tolerable dose of statins. Exclusion criteria: History of walnut allergy Taking other herbal medicines Immune system defects Pregnancy Renal or liver failures Uncontrolled thyroid disease Triglyceride>350 mg/dl Drugs that increase serum glucose levels Neurological or psychiatric disorders Lactation

One group of patients is given a capsule containing 500 mg of internal septum of Juglans regia L.extract and the other group is given a placebo capsule (containing 500 mg pectin) for 3 months.

Low-density lipoprotein cholesterol, Triglycerides and Lipoprotein (a)

Due to the COVID-19 pandemic, patients do not refer to medical centers. So, it was decided to reduce the number of patients from 80 to 60. for this purpose, we consulted to a statistician.

In this study, block randomization will be used to balance the number of samples assigned to each group. For this purpose, 10 blocks of 8 members with different sequences, but equal proportions are composed of two groups A and B and are numbered from 1 to 10. With the RANDBETWEEN function, 10 random number between 1 and 10 is specified, the corresponding blocks of these numbers are placed in a row, and a random chain of groups A and B is formed. Group A is selected as the intervention group and group B as the control group. In order to conceal the random allocation, 80 envelopes with aluminum wrappers (in order to obscure the contents of the envelopes) will be prepared and the letters A and B will be recorded on the cards and the cards will be placed in the envelopes in a random chain. Finally, by entering the study, patients will open the envelopes in order and their assigned group will be revealed.

In this study, both of patients and researcher are blinded. Placebo is prepared the same as the drug capsule. Drug and placebo are coded into A and B by the third supervisor and randomized by block randomization method.