The investigation of the therapeutic effects of Piacidin capsule in patients with type 2 diabetes mellitus: a double-blind study
Design
In the present study, the sample size will include 66 patients who will be divided into two groups, placebo and treatment (33 patients in each group). Piacidin capsules will be prescribed once/day for three months.
Settings and conduct
Patients with type 2 diabetes will be included from Baqiyatullah Hospital, Tehran, Iran. Sixty-six diabetic patients were randomly divided into two groups of 33 patients: placebo and piacidin capsule groups. Piacidin and placebo (300 mg) capsules will be prescribed once a day for three months for both groups. In addition, patients and the person who evaluating the results will not be aware of the status of their assignment to the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
The blood triglyceride level should be between 150 and 500 mg/dL. HbA1c level should be less than 8.5%. Patients should not change their blood sugar-lowering drug regimen. Patients should not have systemic diseases.
Exclusion criteria:
Uncontrollable blood pressure- Pregnancy or breastfeeding- Mental and psychological disorders- Addiction - Hyperthyroidism
Intervention groups
In the present study, sixty-six diabetic patients will be randomly divided into two groups of 33 people, placebo and treatment. Placebo capsules and piacidin capsules (300 mg) will be prescribed once/day for three months for the treatment group. The placebo group will be prescribed a capsule similar to the original capsule daily for 3 months.
Main outcome variables
HbA1c; FBS ; serum concentration of nitric oxide; serum concentration of lipids; insulin resistance; Serum levels of glutathione and malondialdehyde
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110614006804N3
Registration date:2024-01-23, 1402/11/03
Registration timing:prospective
Last update:2024-01-23, 1402/11/03
Update count:0
Registration date
2024-01-23, 1402/11/03
Registrant information
Name
Mohammad Javad Behzadnia
Name of organization / entity
Baghyatallah medical sciences university
Country
Iran (Islamic Republic of)
Phone
+98 21 8126 2012
Email address
behzadnia@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-20, 1402/12/01
Expected recruitment end date
2024-08-22, 1403/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The investigation of the therapeutic effects of Piacidin capsule in patients with type 2 diabetes mellitus: a double-blind study
Public title
The effects of Piacidin in treatment of diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1- Blood triglyceride level should be between 150 and 500 mg/dL. 2- HbA1c level should be less than 8.5%. 3- The age of patients should be between 30 and 65 years. 4- Patients should not make any changes in their blood sugar lowering drug regimen or their physical activity.5- Patients should not have systemic diseases or malignancy or chronic kidney or liver diseases.
Exclusion criteria:
Age
From 30 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
66
More than 1 sample in each individual
Number of samples in each individual:
2
The patients' blood samples will be taken twice (once before the start of the treatment and the second time, three months after the Piacidin capsule administration).
Randomization (investigator's opinion)
Randomized
Randomization description
First, piacidin and placebo capsules will be prepared in the same packaging and appearance and size. Then, they are coded based on the codes already prepared using random numbers table.
Randomization method: Permuted block randomization is done so that first all blocks of size 4 containing two codes A and B are prepared and then random blocks are selected by placement using random numbers table (17 blocks). Each of codes is randomly assigned to one of the groups. The list of codes for each drug will remain with one of the executors until the end of the study. Numerical codes from 1 to 66 are recorded on drugs, and patients receive drug no. 1 to 66 after entering the study, respectively.
Blinding (investigator's opinion)
Double blinded
Blinding description
In the present study, patients will be divided into treatment and placebo groups. The treatment group will receive piacidin capsule. The placebo group will receive placebo capsule; which is similar in color, shape and size to the piacidin capsule. First, we explain to the patients that they will receive one of the two treatments, piacidin or placebo, randomly. Patients are put in group A or B. According to this, one of the drugs that are completely identical in appearance and only tagged as A, B will be prescribed for him/her. Participants (diabetic patients) and Outcome assessor will be blinded.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Baqiyatallah hospital
Street address
Trauma Research Center; Baqiyatallah University of Medical Sciences; Nosrati alley; Sheikh Bahaie street; Molla Sadra street; Vanaq square
City
Tehran
Province
Tehran
Postal code
1435916471
Approval date
2023-12-11, 1402/09/20
Ethics committee reference number
IR.BMSU.BAQ.REC.1402.085
Health conditions studied
1
Description of health condition studied
type 2 diabetes mellitus
ICD-10 code
Type 2 dia
ICD-10 code description
E11
Primary outcomes
1
Description
Quantitative measurement of serum nitric Oxide, glutathione and malondialdehyde levels, blood sugar and lipid levels
Timepoint
before drug administration (day 0) and 3 month after drug administration (day 90)
Method of measurement
Oxidative stress and nitric oxide serum levels will be measured using specific biochemical kits, blood sugar and lipids variables will be assessed based on individual laboratory sample results.
Secondary outcomes
1
Description
none applicable
Timepoint
none applicable
Method of measurement
none applicable
Intervention groups
1
Description
Intervention group: Includes diabetic patients who receive piacidin capsules (300 mg).
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data is shareable after de-identifying individuals.
When the data will become available and for how long
After publication of article
To whom data/document is available
For academic and scientific researchers and institutions
Under which criteria data/document could be used
After researcher's request assessment, it could be possible for sharing the data.
From where data/document is obtainable
Via the corresponding author of the research.
What processes are involved for a request to access data/document
First of all a requesting email should send for the corresponding author;after the confirmation of the sender identity and his/her goal, we could share the data.