Protocol summary

Study aim
En supply of medicinal plants in the form of antidiabetic pills and antidiabetic snacks
Design
A clinical trial with a control group, with parallel groups, double-blind, randomized
Settings and conduct
This study is conducted in Razi University. At the beginning of the study, 1 and 2 months after the study, fasting glucose serum level, glycosylated hemoglobin blood level, 2 hours postprandial glucose serum level are measured.
Participants/Inclusion and exclusion criteria
Based on the calculated sample size, a number of women and men between the ages of 18-65 years old, people prone to type 2 diabetes due to being overweight or suffering from type 2 diabetes with fasting blood sugar more than 125 or sugar after breakfast more than 200 or level Glycosylated hemoglobin more than 6 are included in the study. Pregnant and lactating patients, with glycosylated hemoglobin more than 10, requiring insulin injections, suffering from type chronic and acute kidney, liver, heart, vascular diseases are excluded from the study.
Intervention groups
Patients are classified into 5 categories: capsule, cocoa milk, herbal extract, pastille and weight loss. Herbal capsule category into two groups: synthetic drugs plus herbal capsule and synthetic drugs plus placebo, cocoa milk category into two groups: synthetic drugs plus enriched cocoa milk and synthetic drugs plus placebo, herbal extract category into three Group: synthetic drugs plus extract extracted using a new method and synthetic drugs plus extract extracted using a conventional method and synthetic drugs plus placebo, pastille category into two groups: synthetic drugs plus enriched pastille and drugs Artificial in addition to placebo, the weight loss category is divided into two groups: weight loss capsules and placebo.
Main outcome variables
Fasting glucose serum level; Glycosylated hemoglobin blood level; 2 hours postprandial glucose serum level

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240402061400N1
Registration date: 2024-06-24, 1403/04/04
Registration timing: registered_while_recruiting

Last update: 2024-06-24, 1403/04/04
Update count: 0
Registration date
2024-06-24, 1403/04/04
Registrant information
Name
Nasim Batooie
Name of organization / entity
Razi University
Country
Iran (Islamic Republic of)
Phone
+98 83 3427 0181
Email address
nasim.batooie90@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-21, 1403/04/01
Expected recruitment end date
2024-09-22, 1403/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Supply of medicinal plants in the form of antidiabetic pills and antidiabetic snacks
Public title
Supply of medicinal plants in the form of antidiabetic pills and antidiabetic snacks
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diabetes diagnosis with fasting blood sugar over 125, or postprandial glucose over 200 or glycosylated hemoglobin level greater than 6 Patient willingness and signed informed consent People prone to diabetes due to high weight
Exclusion criteria:
Pregnant and breastfeeding Glycosylated hemoglobin over 10 Suffering from chronic and acute kidney, heart and vascular diseases Corticosteroids use Requiring insulin injections or diagnosis of type 1 diabetes
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 220
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization is done using a table of random numbers.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the patients, the prescribing physician, the person in charge of data collection, the researcher who comments on the effectiveness of the product, the person who evaluates the outcomes, and the person who analyzes the data are not aware of the type of drug.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Razi University
Street address
Zakariai Razi Blvd., Taq-e Bostan
City
Kermanshah
Province
Kermanshah
Postal code
6714414971
Approval date
2023-11-11, 1402/08/20
Ethics committee reference number
IR.RAZI.REC.1402.104

Health conditions studied

1

Description of health condition studied
Diabetes mellitus
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus

Primary outcomes

1

Description
Glycosylated hemoglobin blood level
Timepoint
At the beginning of the study, 1 and 2 months after the study
Method of measurement
Medical laboratory

2

Description
Fasting glucose serum level
Timepoint
At the beginning of the study, 1 and 2 months after the study
Method of measurement
Medical laboratory

3

Description
2 hours postprandial glucose serum level
Timepoint
At the beginning of the study, 1 and 2 months after the study
Method of measurement
Medical laboratory

Secondary outcomes

1

Description
Lipid Profile
Timepoint
At the beginning of the study, 1 and 2 months after the study
Method of measurement
Medical laboratory

2

Description
Liver enzymes
Timepoint
At the beginning of the study, 1 and 2 months after the study
Method of measurement
Medical laboratory

Intervention groups

1

Description
Intervention group in the capsule category: in addition to standard diabetes treatment, one herbal capsule (500 mg) three times a day for two months.
Category
Treatment - Drugs

2

Description
Control group in the capsule category: in addition to standard diabetes treatment, one placebo capsule (500 mg) three times a day for two months.
Category
Placebo

3

Description
Control group in the cocoa milk category: in addition to the standard treatment of diabetes, 200 cc of placebo milk three times a day for two months.
Category
Treatment - Drugs

4

Description
Intervention group in the cocoa milk category: in addition to the standard diabetes treatment, 200 cc of enriched cocoa milk three times a day for two months.
Category
Treatment - Drugs

5

Description
Control group in the plant extract category: in addition to the standard treatment of diabetes, 5 cc of placebo three times a day for two months.
Category
Treatment - Drugs

6

Description
Intervention group in the herbal extract category: in addition to the standard treatment of diabetes, 5 cc of herbal extract extracted using conventional methods three times a day for two months.
Category
Treatment - Drugs

7

Description
Intervention group in the herbal extract category: in addition to the standard treatment of diabetes, 5 cc of the extract extracted using the new method three times a day for two months.
Category
Treatment - Drugs

8

Description
Control group in the pastille category: in addition to the standard treatment of diabetes, 50 grams of placebo three times a day for two months.
Category
Treatment - Drugs

9

Description
Intervention group in the pastille category: in addition to the standard treatment of diabetes, 50 grams of enriched pastille three times a day for two months.
Category
Treatment - Drugs

10

Description
Control group in the weight loss category: in addition to standard diabetes treatment, one placebo capsule three times a day for two months.
Category
Treatment - Drugs

11

Description
Intervention group in the weight loss category: in addition to the standard treatment of diabetes, one herbal weight loss capsule three times a day for two months.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Razi University
Full name of responsible person
Nasim Batooie
Street address
Zakariai Razi Blvd., Taq-e Bostan
City
Kermanshah
Province
Kermanshah
Postal code
6714414971
Phone
+98 83 3427 7605
Email
nasim.batooie90@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Razi University Vice president of Research and Technology
Full name of responsible person
Kianoosh Cheghamirza
Street address
Zakariai Razi Blvd., Taq-e Bostan
City
کرمانشاه
Province
Kermanshah
Postal code
6714414971
Phone
+98 83 3427 0181
Email
cheghamirza@yandex.ru
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Razi University Vice president of Research and Technology
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
Razi University
Full name of responsible person
Nasim Batooie
Position
Non-faculty researcher
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Zakariai Razi Blvd., Taq-e Bostan
City
Kermanshah
Province
Kermanshah
Postal code
6714414971
Phone
+98 83 3427 0181
Email
nasim.batooie90@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Razi University
Full name of responsible person
Nasim Batooie
Position
Non-faculty researcher
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Zakariai Razi Blvd., Taq-e Bostan
City
Kermanshah
Province
Kermanshah
Postal code
6714414971
Phone
+98 83 3427 0181
Email
nasim.batooie90@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Razi University
Full name of responsible person
Nasim Batooie
Position
Non-faculty researcher
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Zakariai Razi Blvd., Taq-e Bostan
City
Kermanshah
Province
Kermanshah
Postal code
6714414971
Phone
+98 83 3427 0181
Email
nasim.batooie90@gmail.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
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