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Comparison of the effect of Ganoderma lucidium and Kambucha on blood sugar in patients with type 2 diabetes

Protocol summary

Study aim
Comparison of the effect of Ganoderma lucidium and Cambodia on blood sugar in patients with type 2 diabetes
Design
Clinical trial with control group, with parallel, randomized groups, on 75 patients.
Settings and conduct
In this study, a group of type 2 diabetic patients referred to the diabetes clinic of Qazvin city hospital enter the study.The first group, in addition to the previous oral anti-diabetic drugs, 1 gram per day in the first week, 2 grams per day in the second week and From the Next second week, 3 grams per day of pure Ganoderma mushroom powder can be used .The second group of intervention can drink a glass of kambucha in the first week and From the Next second week can drink 2 glasses of kambucha a day after meals. In the third group, which is the control group,Continuation of medical treatment will be followed by the previous method.
Participants/Inclusion and exclusion criteria
75 patients with type 2 diabetes who Inclusion criteria : They took oral antidiabetic drugs and had fasting blood sugar greater than or equal to 140 mg / dL and less than 200 mg / dL and exclusion criteria: No side effects such as retinopathy, proliferative, creatinine above 2.1 and triglyceride above 40 mg / dL, selected.
Intervention groups
The first group, in addition to the previous oral anti-diabetic drugs, 1 gram per day in the first week, 2 grams per day in the second week and From the Next second week, 3 grams per day of pure Ganoderma mushroom powder can be used .The second group of intervention can drink a glass of kambucha in the first week and From the Next second week can drink 2 glasses of kambucha a day after meals. In the third group, which is the control group,Continuation of medical treatment will be followed by the previous method.
Main outcome variables
Patients' fasting blood sugar, blood sugar 2 hours after a meal

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190919044819N3
Registration date: 2020-10-26, 1399/08/05
Registration timing: prospective

Last update: 2020-10-26, 1399/08/05
Update count: 0
Registration date
2020-10-26, 1399/08/05
Registrant information
Name
narges hosseini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7768 4704
Email address
nargeshossini123@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-03-19, 1399/12/29
Expected recruitment end date
2023-01-10, 1401/10/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Ganoderma lucidium and Kambucha on blood sugar in patients with type 2 diabetes
Public title
Comparison of the effect of Ganoderma lucidium and Kambucha on blood sugar in patients with type 2 diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
With type 2 diabetes with fasting blood sugar between 140 and 200 mg / dL Be over 18 years old Assessment tools to fully understand the instructions. Read and sign informed consent. Not using of immunosuppressive drugs(Kambucha drink can activate the immune system.) Not using Anticoagulant therapy Not having neuropsychological, cognitive diseases Not having cardiac diseases Not having renal diseases Not having Allergic history Not having retinopathy Not having Creatinine above 1.2 mg / dL Not having Triglycerides above 40 mg / dL
Exclusion criteria:
Insulin consumption Is pregnant or suspected pregnancy Participation in another study that could affect results
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 75
Randomization (investigator's opinion)
Randomized
Randomization description
Individuals are randomly assigned to one of three study groups using a table of random numbers From 75 people, three groups of 25 items should be selected as a sample, we should first give each of them as a member of the community a two-digit code (01, 02, 03, ..., 75). Then go to the table, select the starting point and move in the direction of the row or column based on the adjacent two-digit numbers. We choose the first two-digit number less than 75 as the first example and ignore numbers greater than 75. He goes on to do this until we can select three groups of 25 cases as examples.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Qazvin University of Medical Sciences
Street address
Shahid Bahonar Boulevard, Qazvin University of Medical Sciences
City
gazvin
Province
Qazvin
Postal code
34417431874
Approval date
2020-09-05, 1399/06/15
Ethics committee reference number
IR.QUMS.REC.1399.207

Health conditions studied

1

Description of health condition studied
Patients with type 2 diabetes
ICD-10 code
E08
ICD-10 code description
Diabetes mellitus due to underlying condition

Primary outcomes

1

Description
Fasting blood sugar
Timepoint
Fasting blood sugar will be measured and analyzed at the first visit and also after the end of 6 weeks of treatment.
Method of measurement
Glucometer

2

Description
Glucose two hours after a meal
Timepoint
Glucose two hours after a meal will be measured and analyzed at the first visit and also after the end of 6 weeks of treatment.
Method of measurement
Glucometer

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group1: In addition to the previous oral antidiabetic drugs, the first group can consume 1 gram per day in the first week, 2 grams per day in the second week, and from the second week onwards, 3 grams per day of pure Ganoderma mushroom powder. Mix Ganoderma mushroom powder as a drink with a glass of boiling water and use it after meals.
Category
Treatment - Other

2

Description
Control group: In the third group, which is the control group, the continuation of drug treatment as before will be followed. The studied patients will be treated with glibenclamide and metformin in the same groups.
Category
Treatment - Other

3

Description
Intervention group2: The second group can drink one cup of kambucha in the first week and 2 cups of kambucha a day after meals from the second week onwards.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Diabetes Clinic of Velaiat Hospital
Full name of responsible person
Leili Yekefallah
Street address
Qazvin University of Medical Sciences, Bahonar,Qazvin,Iran
City
Qazvin
Province
Qazvin
Postal code
34411743148
Phone
+98 28 3333 6001
Email
Leili_fallah@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr.Mohammad Mahdi Emamjomeh
Street address
Qazvin University of Medical Sciences, Bahonar,Qazvin,Iran
City
Qazvin
Province
Qazvin
Postal code
3441343184
Phone
+98 28 3333 6001
Email
Apeymani@qums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Leili Yekefallah
Position
Assistant Professor of Qazvin Nursing School
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Qazvin University of Medical Sciences, Bahonar,Qazvin,Iran
City
Qazvin
Province
Qazvin
Postal code
34411743148
Phone
+98 28 3333 6001
Email
Leili_fallah@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Leili Yekefallah
Position
Assistant Professor of Qazvin Nursing School
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Qazvin University of Medical Sciences, Bahonar,Qazvin,Iran
City
Qazvin
Province
Qazvin
Postal code
3441341184
Phone
+98 0283338034
Email
Leili_fallah@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Leili Yekefallah
Position
Assistant Professor of Qazvin Nursing School
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Qazvin University of Medical Sciences, Bahonar,Qazvin,Iran
City
Qazvin
Province
Qazvin
Postal code
3441341184
Phone
+98 0283338034
Email
Leili_fallah@yahoo.com

Sharing plan

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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is 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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Comparison of the effect of Ganoderma lucidium and Cambodia on blood sugar in patients with type 2 diabetes
When the data will become available and for how long
6 months after printing the results
To whom data/document is available
Qazvin University of Medical Sciences
Under which criteria data/document could be used
Through a valid university site
From where data/document is obtainable
Qazvin- Qazvin University of Medical Sciences- School of Nursing and Midwifery
What processes are involved for a request to access data/document
Send authors email
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