Investigation the effect of achillea millefolium oral supplement on some biochemical and inflammatory blood factors in patients with type 2 diabetes referred to Rafsanjan diabetes clinic, in 2023
Investigation the effect of achillea millefolium oral supplement on some biochemical and inflammatory blood factors in patients with type 2 diabetes referred to Rafsanjan diabetes clinic, in 2023
Design
Clinical trial with a control group, with parallel groups, double-blind, randomized, phase 2 on 70 patients. The rand function of Excel software was used for randomization.
Settings and conduct
The units of research in this study are 70 patients with type 2 diabetes referred to the diabetes clinic in Rafsanjan, who were included in the study based on the conditions and criteria of entry. The conditions of all the studied patients should be the same, and after checking the mentioned conditions, the patients will be randomly divided into two groups of 35 people.
After the three-month period of treatment of the patients, 10 cc of the patients' blood will be taken by a skilled person to measure the cytokine factors in question and also the studied enzymes.
Participants/Inclusion and exclusion criteria
Type 2 diabetes; Age over 40 years; Lack of pregnancy; lack of breastfeeding; Non-participation in another research project; History of diabetes for at least five years; No history of allergies to medicinal herbs
Intervention groups
Intervention: user of yarrow capsules
Control: recipient of placebo
Main outcome variables
The possibility of side effects following the oral intake of yarrow extract such as skin itching and hives
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230612058459N1
Registration date:2023-06-27, 1402/04/06
Registration timing:prospective
Last update:2023-06-27, 1402/04/06
Update count:0
Registration date
2023-06-27, 1402/04/06
Registrant information
Name
Vahid Mohammadi-Shahrokhi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 913 191 1230
Email address
drvahid@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-11, 1402/04/20
Expected recruitment end date
2023-09-11, 1402/06/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation the effect of achillea millefolium oral supplement on some biochemical and inflammatory blood factors in patients with type 2 diabetes referred to Rafsanjan diabetes clinic, in 2023
Public title
The effect of achillea millefolium on blood inflammatory factors in patients with type 2 diabetes
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Having type II diabetes
Age over 40 years old
Inform consent for participate in the study
History of diabetes for at least five years
Exclusion criteria:
Participate in another research project
Having other physical illnesses in addition to diabetes
Pregnancy and lactation
Allergy to medicinal plants
Age
From 40 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
31
Randomization (investigator's opinion)
Randomized
Randomization description
Random classification by minimization method: In this method, classes are first formed based on the important variables desired by the researcher, which in this study are blood tests, then among the patients who meet the entry criteria, the first samples are randomly selected (on based on lion and line) are included in the study and are placed in one of the groups. For the following examples, the sum of the indicators in two groups is given attention and the sample is assigned to the group that has a lower sum.
Blinding (investigator's opinion)
Double blinded
Blinding description
Drugs and placebo are similar in shape, packaging, color and smell. In order to blind patients, the pharmacist is asked to identify the drug and the placebo with numbers one and two so that the researcher does not know about the content of the capsules (drug or placebo). Patients are also given the capsules numbered 1 and 2 and the patient also doesn't know about the content of the capsules. The blinding will also be available for the analyzer, and after completing the analysis, the pharmacist will be asked to disclose the content of the capsules
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Rafsanjan University of Medical Sciences
Street address
Central office of Rafsanjan University of Medical Sciences (RUMS), Imam Ali Blvd, Ali Ibn Abitaleb square
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Approval date
2023-05-31, 1402/03/10
Ethics committee reference number
IR.RUMS.REC.1402.032
Health conditions studied
1
Description of health condition studied
diabetes
ICD-10 code
E08.40
ICD-10 code description
Diabetes mellitus due to underlying condition with diabetic neuropathy, unspecified
Primary outcomes
1
Description
Mean blood inflammatory factors.
Timepoint
At the beginning of the study (before the intervention) and 12 weeks after the intervention
Method of measurement
Biochemical autoanalyzer
Secondary outcomes
1
Description
Liver enzymes
Timepoint
At the beginning of the study (before the intervention) and 12 weeks after the intervention
Method of measurement
Biochemical autoanalyzer
2
Description
Michigan neuropathy questionnaire
Timepoint
At the beginning of the study (before the intervention) and 12 weeks after the intervention
Method of measurement
questionnaire
Intervention groups
1
Description
Intervention group: In this group, patients receive a 500 mg capsule of achillea millefolium (made by Rafsanjan Asans Daru company) daily for 12 weeks.
Category
Treatment - Other
2
Description
Control group: In this group, patients will receive placebo (a 500 mg capsule of cellulose, made by Rafsanjan Asans Daru company ) daily for 12 weeks
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Diabetes clinic of Ali Ebn Abitaleb Hospital
Full name of responsible person
Parisa Balaei
Street address
Ali IBn Abitaleb hospital, Mofateh Blvd, Ali IBn Abitaleb square
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 2282
Email
aliebn_hospital@rums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Reza Vazirinejad
Street address
Central office of Rafsanjan University of Medical Sciences (RUMS), Imam Ali Blvd, Ali Ibn Abitaleb square
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0097
Email
vcrt@rums.ac
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rafsanjan 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
Rafsanjan University of Medical Sciences
Full name of responsible person
Vahid mohammadi shahrokhi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Immunology
Street address
Faculty of Medicine, Rafsanjan University of Medical Sciences
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0038
Email
v_md_sh@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Vahid Mohammadi shahrokhi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Immunology
Street address
Faculty of Medicine, Rafsanjan University of Medical Sciences
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0038
Email
v_md_sh@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Vahid Mohammadi Shahrokhi
Position
Asistant professor
Latest degree
Specialist
Other areas of specialty/work
Immunology
Street address
Faculty of Medicine, Rafsanjan University of Medical Sciences
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0038
Email
v_md_sh@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
Not applicable
Analytic Code
Not applicable
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available