Protocol summary
-
Study aim
-
This study aims to find out synergistic effect Berberis aristata and metformin in lowering blood glucose level in diabetic patients.Diabetes mellitus is a chronic metabolic disorder characterized by high blood glucose levels
-
Design
-
Lottery method, community bases,parallel group, double blinded, randomized control trial.
-
Settings and conduct
-
Study will be conducted at Muhammad Institute of Medical and Allied Sciences Multan after approval from Institutional ethical committee.
-
Participants/Inclusion and exclusion criteria
-
Inclusion criteria:
Age group of 25-70 years Both Genders (Male, Female) Hypertensive patients Married and unmarried Educated and uneducated Diabetic patients
Exclusion criteria:
Any type of mental disability Lactating females Having any type of physical disability History of chest pain, bronchitis, asthma, angina, MI Chronic illness related to cardiorespiratory ailments Any type of major surgery• Pregnant females
-
Intervention groups
-
Patients will be recruited by using the lottery method into three groups. Informed consent will be taken from patient. Group A will be treated with Berberis aristata (550 mg twice a day) orally. Group B will be given metformin orally (500 mg). Group C will be given both Berberis aristata and metformin (550/250 mg once). The treatment regimen will be 6 weeks. Blood glucose, blood pressure, blood cholesterol, respiration rate, heart rate, ketone bodies, HbA1c, DDS score and oxygen saturation of all the patients with diabetes type-2 at baseline and after 6 weeks.
-
Main outcome variables
-
Cardiometabolic and cardiorespiratory parameters including Blood glucose, blood pressure, blood cholesterol, respiration rate, heart rate, ketone bodies, HbA1c, DDS score and oxygen saturation
General information
-
Reason for update
-
Slight modifications
-
Acronym
-
-
IRCT registration information
-
IRCT registration number:
IRCT20230202057310N3
Registration date:
2023-09-07, 1402/06/16
Registration timing:
prospective
Last update:
2024-08-20, 1403/05/30
Update count:
1
-
Registration date
-
2023-09-07, 1402/06/16
-
Registrant information
-
-
Recruitment status
-
Recruitment complete
-
Funding source
-
-
Expected recruitment start date
-
2023-09-10, 1402/06/19
-
Expected recruitment end date
-
2024-01-06, 1402/10/16
-
Actual recruitment start date
-
empty
-
Actual recruitment end date
-
empty
-
Trial completion date
-
empty
-
Scientific title
-
Synergistic Effect of Berberis Aristata and Metformin in Diabetic Patients-A Randomized Controlled Trial
-
Public title
-
Berberis Aristata and Metformin in Diabetic Patients
-
Purpose
-
Treatment
-
Inclusion/Exclusion criteria
-
Inclusion criteria:
Age group of 25-70 years
Both Genders (Male, Female)
Married and unmarried
Educated and uneducated
Diabetic patients
Exclusion criteria:
Any type of mental disability
Lactating females
Having any type of physical disability
History of chest pain
bronchitis
Any type of major surgery
Pregnant females
Asthma
Angina
MI Chronic illness related to cardiorespiratory ailments
-
Age
-
From 25 years old to 70 years old
-
Gender
-
Both
-
Phase
-
1-2
-
Groups that have been masked
-
- Investigator
- Data analyser
-
Sample size
-
Target sample size:
295
-
Randomization (investigator's opinion)
-
Randomized
-
Randomization description
-
We used sealed envelops for lotterty method and randomization of participants was done. Randomization of participants in groups by lottery method Simple randomization.
-
Blinding (investigator's opinion)
-
Double blinded
-
Blinding description
-
Double blinded study was done by keeping blind i-e the physiotherapist as Investigator and data analyser to avoid biasness and ro get the authentic results
-
Placebo
-
Not used
-
Assignment
-
Parallel
-
Other design features
-
Ethics committees
1
-
Ethics committee
-
-
Approval date
-
2023-08-10, 1402/05/19
-
Ethics committee reference number
-
MIMAS/08/27/IAK.DURRANI
Health conditions studied
1
-
Description of health condition studied
-
Diabetes Mellitus
-
ICD-10 code
-
E08
-
ICD-10 code description
-
Diabetes mellitus due to underlying condition
Primary outcomes
1
-
Description
-
Glucose level in diabetic patients
-
Timepoint
-
6 weeks
-
Method of measurement
-
Blood glucose level by glucometer
2
-
Description
-
Cholesterol level
-
Timepoint
-
6 weeks
-
Method of measurement
-
Lipid profile meter
3
-
Description
-
HbA1C
-
Timepoint
-
6 weeks
-
Method of measurement
-
Blood sampling
Secondary outcomes
1
-
Description
-
Cardiorespiratory parameters
-
Timepoint
-
6 weeks
-
Method of measurement
-
Pulse oximeter, Manometer for blood pressure monitoring
Intervention groups
1
-
Description
-
Intervention group: Group A will be treated with Berberis aristata (550 mg twice a day) orally. The treatment regimen will be 6 weeks. Blood glucose, blood pressure, blood cholesterol, respiration rate, heart rate, ketone bodies, HbA1c, DDS score and oxygen saturation of all the patients with diabetes type-2 at baseline and after 6 weeks.
-
Category
-
Treatment - Drugs
2
-
Description
-
Intervention group: Group B will be given metformin orally (500 mg). The treatment regimen will be 6 weeks. Blood glucose, blood pressure, blood cholesterol, respiration rate, heart rate, ketone bodies, HbA1c, DDS score and oxygen saturation of all the patients with diabetes type-2 at baseline and after 6 weeks
-
Category
-
Treatment - Drugs
3
-
Description
-
Intervention group: Group C will be given both Berberis aristata and metformin (550/250 mg once). The treatment regimen will be 6 weeks. Blood glucose, blood pressure, blood cholesterol, respiration rate, heart rate, ketone bodies, HbA1c, DDS score and oxygen saturation of all the patients with diabetes type-2 at baseline and after 6 weeks.
-
Category
-
Treatment - Drugs
1
-
Sponsor
-
-
Grant name
-
Student fund
-
Grant code / Reference number
-
27082023
-
Is the source of funding the same sponsor organization/entity?
-
Yes
-
Title of funding source
-
Muhammad Institute of Medical and Allied Sciences, Multan
-
Proportion provided by this source
-
70
-
Public or private sector
-
Private
-
Domestic or foreign origin
-
Domestic
-
Category of foreign source of funding
-
empty
-
Country of origin
-
-
Type of organization providing the funding
-
Academic
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