To determine the effect of klatin (Glaucium flavum) in the glycaemic control in diabetes patients
Design
Clinical trial with control group, double-blind, randomized, phase 3 on 66 patients with blocked randomization
Settings and conduct
This study will be performed on 66 type 2 diabetic patients who refer to specialized endocrinology clinics in Sari, including Touba Clinic and Imam Khomeini Hospital in Sari, after applying the conditions of entry and exit from the study and completing the informed consent form with random blocking are placed in one of the intervention and control groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria included:
Having type 2 diabetes for at least three months prior to enrollment
Adults over 18 years
Inclusion criteria:
Pregnancy and lactation
History of liver and kidney diseases
Intervention groups
Intervention group: Patients take their oral diabetes medications without any changes and in addition, they receive oral herbal capsules contain 1000 mg of herbal klatin extract three times a day for 60 days
Control group: Patients take their oral diabetes medications without any changes and in addition, they receive placebo 1000 mg capsules (microcrystalline cellulose) three times a day for 60 days.
Main outcome variables
Fasting blood sugar، Hg A1C
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210724051965N1
Registration date:2022-01-18, 1400/10/28
Registration timing:prospective
Last update:2022-01-18, 1400/10/28
Update count:0
Registration date
2022-01-18, 1400/10/28
Registrant information
Name
Ghorban Deyri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3324 3117
Email address
drdeyri41@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-19, 1400/11/30
Expected recruitment end date
2023-02-19, 1401/11/30
Actual recruitment start date
2022-02-19, 1400/11/30
Actual recruitment end date
2023-02-19, 1401/11/30
Trial completion date
2023-02-19, 1401/11/30
Scientific title
Evaluation of the effect of herbal klatin capsule on laboratory indices and quality of life in type 2 diabetes patients
Public title
The effect of klatin capsule on type 2 diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having type 2 diabetes at least three months before enrollment
Adults over 18 years
Exclusion criteria:
Pregnancy
lactation
kidney disease
liver disease
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
66
Actual sample size reached:
66
Randomization (investigator's opinion)
Randomized
Randomization description
Individuals will be randomly assigned to experimental and control groups using the size 4 random block method. For random assignment, each group will be considered as 4 people in 4 modes and therefore 6 different modes can occur: AABB-ABAB-ABBA-BAAB-BABA-BBAA. The number of people in each group is equal and this is repeated for 66 patients. According to the above block, 66 envelopes are prepared and A or B are placed in each envelope and numbers 1 to 66 are written on the envelopes. Someone outside the research team puts the letters A and B in the envelopes. A or B each represent the intervention or control group, which determines the type of intervention and A or B being a statistician.
Blinding (investigator's opinion)
Double blinded
Blinding description
The drugs will be given in coded envelops. The shape of the medications and placebos will be perfectly the same. Therefore, patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. Thus, the trial will be run as double-blind.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Mazandaran University of Medical Sciences
Street address
Moallem square, Moallem avenue
City
Sari
Province
Mazandaran
Postal code
48168-95474
Approval date
2021-11-03, 1400/08/12
Ethics committee reference number
IR.MAZUMS.REC.1400.544
Health conditions studied
1
Description of health condition studied
Type 2 diabetes mellitus
ICD-10 code
E11.9
ICD-10 code description
Type 2 diabetes mellitus without complications
Primary outcomes
1
Description
Fating blood sugar
Timepoint
At the beginning of the study (before the intervention) and 60 days after intervention
Method of measurement
Biochemistry- Glucose oxidase (enzymatic method)
2
Description
Hemoglobin A1c
Timepoint
At the beginning of the study (before the intervention) and 60 days after intervention
Method of measurement
Biochemistry- Calorimetry
3
Description
Cholesterol
Timepoint
At the beginning of the study (before the intervention) and 60 days after intervention
Method of measurement
Calorimetric enzymatic
4
Description
Triglyceride
Timepoint
At the beginning of the study (before the intervention) and 60 days after intervention
Method of measurement
Calorimetric enzymatic
Secondary outcomes
1
Description
Blood creatinine
Timepoint
Before the intervention and 60 days after the intervention
Method of measurement
Enzymatic
2
Description
Blood urea nitrogen
Timepoint
Before the intervention and 60 days after the intervention
Method of measurement
Calorimetric enzymatic
3
Description
Quality of Life
Timepoint
Before the intervention and 60 days after the intervention
Method of measurement
Quality of Life Assessment Questionnaire 15 questions for patients with diabetes
Intervention groups
1
Description
Intervention group:In this group patients take their oral diabetes medications without any changes and in addition, they received klatin capsule (Contains 1000 mg of klatin plant extract of Plasma Darman Sarve Sepid Company) three times a day for 60 days.
Category
Treatment - Drugs
2
Description
Control group (placebo): In this group patients take their oral diabetes medications without any changes and in addition, they receive placebo (capsule containing 1000 mg microcrystalline cellulose of Plasma Darman Sarve Sepid Company) three times a day for 60 days.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital, Sari city
Full name of responsible person
Sedighe Yousefi
Street address
Center for Traditional Medicine and Complementary Medicine of Mazandaran University; Khazar Boulevard, Khazar Square of Sari
City
Sari
Province
Mazandaran
Postal code
48168-95475
Phone
+98 11 3304 4000
Email
s.yousefi@mazums.ac.ir
2
Recruitment center
Name of recruitment center
Touba Center of Mazandaran University of Medical Sciences
Full name of responsible person
Ghorban Deyri
Street address
Khazar Boulevard; Khazar Square
City
Sari
Province
Mazandaran
Postal code
4816833131
Phone
+98 11 3304 4000
Email
drdeyri41@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Majid Saidi
Street address
Deputy of Research and Technology Mazandaran University of Medical Sciences, Moalem Ave., Moalem Square
City
Sari
Province
Mazandaran
Postal code
48168-95474
Phone
+98 11 3325 7230
Email
pajhooheshi@mazums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Sedighe Yousefi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Khazar Blvd., Khazar square
City
Sari
Province
Mazandaran
Postal code
48168-95475
Phone
+98 11 3324 4893
Email
s.yousefi@mazums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Sedighe Yousefi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Touba clinic , Khazar Blvd., Khazar square
City
Sari
Province
Mazandaran
Postal code
48168-95475
Phone
+98 11 3324 4893
Fax
+98 11 3324 4894
Email
s.yousefi@mazums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Ghorban Deyri
Position
P.h.D student
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Khazar Blvd., Khazar square
City
Sari
Province
Mazandaran
Postal code
48168-95475
Phone
+98 11 3324 4893
Email
drdeyri41@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