Evaluation of the effect of Ganoderm lucidum (with usual diabetes medications) on blood glucose control in type 2 diabetic patients: A placebo-controlled double-blind clinical trial
To determine the effect of Ganoderma in the glycaemic control in diabetes patients
Design
Clinical trial with placebo control group with parallel groups, phase 2 double-blind randomized study on 72 patients with simple randomization
Settings and conduct
This study is performed Diabetes Research Center, Endocrinology and Metabolism Research Institute, Tehran University of Medical Sciences, Tehran, Iran. This randomized double blind placebo controlled clinical trial is performed in parallel groups of diabetic patients. Physicians, patients, researchers, and data analyzer are blind to study groups.
Participants/Inclusion and exclusion criteria
Type 2 diabetic patients aged 30-70 years with HbA1c 8-10% are included in the study.
People with heart and kidney failure, insulin-treated patients, and pregnant and lactating women are excluded from the study.
Intervention groups
Patents in intervention groups will receive ganoderma capsule (1 gr at morning and 1 gr at nigh) or placebo with the same feature for 12 weeks.
Main outcome variables
Blood glucose
General information
Reason for update
Acronym
none
IRCT registration information
IRCT registration number:IRCT20200716048118N1
Registration date:2020-11-25, 1399/09/05
Registration timing:registered_while_recruiting
Last update:2020-11-25, 1399/09/05
Update count:0
Registration date
2020-11-25, 1399/09/05
Registrant information
Name
Fatemeh Bandarian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8833 8742
Email address
fbandarian@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-22, 1399/08/01
Expected recruitment end date
2021-05-21, 1400/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of Ganoderm lucidum (with usual diabetes medications) on blood glucose control in type 2 diabetic patients: A placebo-controlled double-blind clinical trial
Public title
The effect of Ganoderm on glycemic control in diabetic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Type 2 Diabetic patients
age 30-70
HbA1c 8-10%
Exclusion criteria:
liver failure
renal failure
pregnant women
lactating women
insulin therapy
Age
From 30 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Data analyser
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization by using random number table is used for randomization.
Blinding (investigator's opinion)
Double blinded
Blinding description
physician is blind about the study group.
Patient is blind about the study group.
investigator is blind about the study group.
data analyzer is blind about the study group.
Assignment of patients in treatment and placebo groups is performed by a nurse out of above mentioned groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Endocrinology and Metabolism Research Institute, Tehran University of Medical Sc
Street address
Diabetes Research Center, 5th floor, Diabetes clinic, Cross Heyat Ave., Shahrivar Ave., North Kargar St.,
City
Tehran
Province
Tehran
Postal code
1411716411
Approval date
2020-09-28, 1399/07/07
Ethics committee reference number
IR.TUMS.EMRI.REC.1399.046
Health conditions studied
1
Description of health condition studied
Diabetes mellitus type 2
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus
Primary outcomes
1
Description
Blood glucose
Timepoint
Begging and at after 12 weeks of treatment
Method of measurement
Biochemical method and autoanalyser
Secondary outcomes
1
Description
Cholesterol Total
Timepoint
Triglyceride
Method of measurement
Biochemistry- Calorimetry
Intervention groups
1
Description
Intervention group: In this group patients take their oral diabetes medications without any changes and in addition, they receive treatment with ganoderma including one ganoderma capsule (one gram ganoderma) in morning and one in night for 12 weeks
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 treatment with placebo including one placebo capsule (one gram placebo) in morning and one in night for 12 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Diabetes Clinic affiliated to Diabetes Research Center
Full name of responsible person
Fatemeh Bandarian
Street address
Diabetes Clinic, Cross Heyat Ave., Shahrivar Ave., North Kargar St.,
City
Iran
Province
Tehran
Postal code
1411716411
Phone
+98 21 8833 8742
Fax
+98 21 8833 8742
Email
Diabetes.research@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yas Daru
Full name of responsible person
Ensieh Nasli-Esfahani
Street address
Diabetes Research Center, 5th floor, Diabetes Clinic, Cross Heyat Ave., Shahrivar Ave., North Kargar St.,
City
Tehran
Province
Tehran
Postal code
1411716411
Phone
+98 21 8833 8742
Email
Diabetes.research@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yas Daru
Proportion provided by this source
100
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
Industry
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Bandarian
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Molecular Medicine
Street address
Diabetes Research Center, 5th floor, Diabetes Clinic, Cross Heyat Ave., Shahrivar Ave., North Kargar St.,