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
Design
Clinical trial with control group, parallel groups, double-blind, randomized, phase 3 on 80 patients.
Settings and conduct
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.
Participants/Inclusion and exclusion criteria
inclusion criteria:
Obtain informed consent from patients.
Patients aged 25 to 70 years.
patients with dyslipidemia who have serum low density 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
triglycerides>350 mg/dl
Drugs that increase serum glucose levels
Neurological or psychiatric disorders
lactation
Intervention groups
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.
Main outcome variables
Low-density lipoprotein cholesterol, triglycerides, Lipoprotein a
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201227049850N1
Registration date:2021-10-03, 1400/07/11
Registration timing:retrospective
Last update:2021-10-03, 1400/07/11
Update count:1
Registration date
2021-10-03, 1400/07/11
Registrant information
Name
mehrzad mirshekari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4441 2540
Email address
mehrzad.mirshekari@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-23, 1400/05/01
Expected recruitment end date
2021-09-23, 1400/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
Evaluation of Effect of internal septum of walnut on blood lipids
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Obtain informed consent from patients.
Patients aged 25 to 70 years.
patients with dyslipidemia who have serum LDL-C more than goal based on European Heart Association 2019 guideline despite receiving the maximum or maximum tolerable dose of statins. The therapeutic goals of LDL-C blood levels varies between 55 and 100 mg/dl based on other conditions and diseases in the study participants.
Exclusion criteria:
History of walnut allergy
Taking other herbal medicines
Immune system defects
Pregnancy
Renal failure (eGFR <30 mL / min / 1.73m2)
Liver failure (AST or ALT> × 3 ULN)
Uncontrolled thyroid disease (TSH <LLN or TSH> 1.5 × ULN)
TG>350 mg/dl
Concomitant use of any drug containing estrogen or progesterone, systemic glucocorticoids, cyclosporine, tacrolimus, everolimus, sirolimus, antipsychotic drugs, psychotropic substances or alcohol
Neurological or psychiatric disorders that affect the acceptance of medication and the correct implementation of the study protocol
lactation
Age
From 25 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
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.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, both of patients and researcher are blinded. Placebo is prepared same as the drug capsule. Drug and placebo are coded into A and B by the third supervisor and randomized by block randomization method.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Calculate the logarithm of high-density cholesterol divided by triglycerides
6
Description
Weight, waist and waist to hip
Timepoint
0 and 12 weeks after intervention
Method of measurement
Measurement with a meter
7
Description
systolic and diastolic blood pressure
Timepoint
0 and 12 weeks after intervention
Method of measurement
blood pressure monitor
Intervention groups
1
Description
Intervention group: The intervention group is treated with an oral capsule containing 500 mg of internal septum of Juglans regia L. extract three times a day for 12 weeks.
Category
Treatment - Drugs
2
Description
Control group: The control group is treated with an oral capsule containing 500 mg pectin (placebo) three times a day for 12 weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam khomeini hospital and shariati hospital
Full name of responsible person
soha namazi
Street address
Imam Khomeini Hospital complex, Gharib ave, Tehran city
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 0000
Email
namazisoha@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Sahrayan
Street address
Keshavarz Blvd, Gods Ave, Univercity Building
City
Tehran
Province
Tehran
Postal code
1434783114
Phone
+98 21 3053 8867
Email
mehrzad.mirshekari@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
soha namazi
Position
Professor of Pharmacotherapy, Tehran University of Medical Sciences
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
No. 43, golestan complex, golab ave, sadeghiye, tehran town
City
Tehran
Province
Tehran
Postal code
1451974681
Phone
+98 21 4441 2540
Fax
Email
namazisoha@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
soha namazi
Position
Professor of Pharmacotherapy, Tehran University of Medical Sciences
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
No. 43, golestan complex, golab ave, sadeghiye, tehran town
City
Tehran
Province
Tehran
Postal code
1451974681
Phone
+98 21 4441 2540
Fax
Email
namazisoha@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
soha namazi
Position
Professor of Pharmacotherapy, Tehran University of Medical Sciences
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
No. 43, golestan complex, golab ave, sadeghiye, tehran town
City
Tehran
Province
Tehran
Postal code
1451974681
Phone
+98 21 4441 2540
Fax
Email
namazisoha@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available