This study was designed to investigate the effect of diabetes capsules on improving lipid profile in diabetic patients.
Design
In this study, 70 diabetic patients with impaired lipid profile are divided into two groups of drugs and placebo (35 subjects for each group). The clinical trial phase of this study is 3. Randomization is simple. This study is double-blind. In this study, blood samples are taken before the intervention and after 6 weeks of taking the capsules, and the lipid profile of these people is studied.
Settings and conduct
If the individuals agree to participate in the research, written consent will be obtained from them and their information will be recorded in the relevant questionnaire. The study site is Arak University of Medical Sciences. After 12 hours of fasting blood sampling are taken from the patient.Biochemical tests related to lipid profile are measured.Then, patients with disorders in lipid profile are randomly divided into two groups. One group receives diabetes capsules and the other group receives placebo . This is a double-blind study in which participants and statistical analysts do not know the groups.At the end of the 6-week intervention phase, blood samples are taken again and biochemical factors are measured to evaluate the effectiveness of the diabetes capsule.
Participants/Inclusion and exclusion criteria
Diabetic patients with impaired lipid profile are included in the study.These patients should not have heart disease. If a participant becomes allergic to the capsule during the study or is unable to continue the study, he / she will be excluded from the study.
Intervention groups
The group receiving the drug: This group consume three capsules daily for 6 weeks. The group receiving the placebo: This group consume three capsules daily for 6 weeks .
Main outcome variables
Lipid profile
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141027019705N4
Registration date:2020-09-24, 1399/07/03
Registration timing:registered_while_recruiting
Last update:2020-09-24, 1399/07/03
Update count:0
Registration date
2020-09-24, 1399/07/03
Registrant information
Name
Mehdi Salehi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 3331 8165
Email address
m_salehi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-20, 1399/02/31
Expected recruitment end date
2020-12-20, 1399/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of diabetes capsule (a TIM product ) consumption on lipid profile in patients with hyperlipidemia
Public title
The effect of diabetes capsules on lipid profile
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Not having known heart disease
Having a disorder in lipid profile
Exclusion criteria:
Unwilling to enter the study
Sensitivity to diabetes capsules
Age
From 20 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
The method of assigning subjects to each group is that individuals are assigned every other one to one group.
Blinding (investigator's opinion)
Double blinded
Blinding description
The two groups of drug and placebo receive very similar capsules, and they do not know the contents of the capsule
The statistical analyzer is not informed about the groups..
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
Iran, Arak, Sardasht, Basij Square, near Amiral-Momenin Hospital
City
Arak
Province
Markazi
Postal code
3848176341
Approval date
2020-05-08, 1399/02/19
Ethics committee reference number
IR.ARAKMU.REC.1399.026
Health conditions studied
1
Description of health condition studied
Diabetic patients with impaired lipid profile
ICD-10 code
E78.5
ICD-10 code description
Hyperlipidemia, unspecified
Primary outcomes
1
Description
Improving blood LDL
Timepoint
Measurement of blood LDL in the beginning of the study (before the start of the study) and 6 weeks after the intervention
Method of measurement
Measuring blood LDL using biochemical kits.
2
Description
Improving blood HDL
Timepoint
Measurement of blood HDL in the beginning of the study (before the start of the study) and 6 weeks after the intervention
Method of measurement
Measuring blood HDL using biochemical kits.
3
Description
Improving total cholesterol
Timepoint
Measurement of total cholesterol in the beginning of the study (before the start of the study) and 6 weeks after the intervention
Method of measurement
Measuring total cholesterol using biochemical kits.
4
Description
Improving blood triglycerides
Timepoint
Measurement of blood triglycerides in the beginning of the study (before the start of the study) and 6 weeks after the intervention
Method of measurement
Measuring blood triglycerides using biochemical kits.
5
Description
Improving blood VLDL
Timepoint
Measurement of blood VLDL in the beginning of the study (before the start of the study) and 6 weeks after the intervention
Method of measurement
Measuring blood VLDL using biochemical kits.
Secondary outcomes
1
Description
Weight
Timepoint
Before the intervention and 6 weeks after the intervention
Method of measurement
Scales
2
Description
BMI
Timepoint
Before the intervention and 6 weeks after the intervention
Method of measurement
Weight (kg) / height (meters) to the power of 2
Intervention groups
1
Description
Intervention group: This group received 3 diabetic capsules (500 mg) daily for 6 weeks. Diabetes capsule consists of three plant components (Rhus corindria, Trigonella Foenum and Portulaca Oleracea). This capsule is made by Sanabel Drug Company.
Category
Treatment - Drugs
2
Description
Control group: This group received 3 placebo capsules (500 mg) daily for 6 weeks. This capsule is made by Sanabel Drug Company.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Kowsar Clinic
Full name of responsible person
Mehdi Salehi
Street address
Imam Street, Kowsar Clinic
City
Arak
Province
Markazi
Postal code
3848176341
Phone
+98 86 3417 3645
Email
m_salehi@razi.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Alireza Kamali
Street address
Sardasht, Basij Square, near Amiral-Momenin Hospital
City
Arak
Province
Markazi
Postal code
3848176341
Phone
+98 86 3417 3645
Email
research@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Mehdi Salehi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Sardasht, Basij Square, near Amiral-Momenin Hospital
City
Arak
Province
Markazi
Postal code
3848176341
Phone
+98 86 3417 3645
Email
m_salehi@razi.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mehdi Salehi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Sardasht, Basij Square, near Amiral-Momenin Hospital
City
Arak
Province
Markazi
Postal code
3848176341
Phone
+98 86 3417 3645
Email
m_salehi@razi.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Alireza Niknafs
Position
PhD student
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Sardasht, Basij Square, near Amiral-Momenin Hospital
City
Arak
Province
Markazi
Postal code
3848176341
Phone
+98 86 3417 3645
Email
a.niknafs@arakmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD