Preparation of capsule form of hot water polysaccharide rich extract from Trametes versicolor and effect of it on blood factors in diabetic patients. A Double-Blind, Randomized Clinical Trial
The effect of hot water extract rich in polysaccharide of the medicinal fungus Trametes versicolor on blood factors of diabetic application: a double-blind clinical trial
Design
The present study is a double-blind randomized clinical trial (simple random sampling). This clinical trial consists of two groups, including the intervention group (treated with capsules containing Trametes versicolor) and a placebo group on sixty patients.
Settings and conduct
This study was performed on patients referred to Touba Clinic in Sari in 1399. Treatment steps were explained to all patients. Each patient must receive the relevant capsules within two months. During these two months, the patient will be monitored by researcher via telephone. Blood factors including LDL, FBS, triglycerides, hemoglobin A1C, and other related factors will be evaluated before and after the study.
Participants/Inclusion and exclusion criteria
Age between 20 and 50 years, diagnosis of type 2 diabetes for more than 2 years, no kidney, liver, parathyroid, gastrointestinal and inflammatory diseases
Intervention groups
Intervention group that receive the capsule containing the extract.
The placebo group that receive placebo capsules
Preparation of capsule form of hot water polysaccharide rich extract from Trametes versicolor and effect of it on blood factors in diabetic patients. A Double-Blind, Randomized Clinical Trial
Public title
Clinical effects of capsules containing Trametes versicolor extract
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 20 and 50 years
diagnosis of type 2 diabetes for more than 2 years
No kidney disease
No liver disease
No parathyroid disease
No gastrointestinal diseases
No inflammatory diseases
Exclusion criteria:
Pregnancy and lactation
use of insulin
Use of nonsteroidal anti-inflammatory drugs
smoking
alcohol consumption
people who follow weight loss diets
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The patients were randomly assigned to the two groups (via a random table). In this study, randomization was performed by simple randomization. With the help of a random table, sixty codes were defined and the capsules were coded and the capsules were in One-shaped cans are randomly provided to patients according to defined codes.
The first group receives capsules containing aqueous extract of Trametes versicolor with Avicel powder and the second group receives placebo capsules containing Avicel only.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, two groups of patients and clinical caregiver (specialist physician) are kept blind in the study groups. People will not know how to distribute the capsules. The capsules are available in white containers similar to codes 1 and 2.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ٍEthics committee of Mazandaran University of Medical Sceinces
Street address
Moalem Ave.
City
sari
Province
Mazandaran
Postal code
4847193698
Approval date
2020-09-16, 1399/06/26
Ethics committee reference number
IR.MAZUMS.REC.1399.692
Health conditions studied
1
Description of health condition studied
diabetes
ICD-10 code
E08
ICD-10 code description
Diabetes mellitus due to underlying condition
Primary outcomes
1
Description
Blood factors in diabetic patients
Timepoint
before and after treatment
Method of measurement
blood test
Secondary outcomes
empty
Intervention groups
1
Description
6 capsules of 500 mg containing 250 mg of Trametes versicolor mushroom extract powder in three meals a day for 2 months
Category
Treatment - Drugs
2
Description
Control group: 6 placebo capsules containing 500 mg of Avicel three meals a day for 2 months
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Touba specialized and sub-specialized clinic
Full name of responsible person
Dr. Adeleh Bahar
Street address
Touba specialized and sub-specialized clinic, Caspian Boulevard, Sari city, Mazandaran Province, Iran
City
sari
Province
Mazandaran
Postal code
4847193698
Phone
+98 11 3324 0003
Email
ehabibi@mazums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Ahmad Ali Enayati
Street address
Mazandaran University of Medical Sciences, Moalen Avenue
City
sari
Province
Mazandaran
Postal code
4847193698
Phone
+98 11 3354 3695
Email
ehabibi@mazums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
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
Dr. Emran Habibi
Position
Ph.D. Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
School of Pharmacy, Farah Abad
City
sari
Province
Mazandaran
Postal code
4847193698
Phone
+98 11 3354 3695
Email
emrapharm@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Emran Habibi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Pharmacognosy
Street address
School of Pharmacy, Farah Abad
City
sari
Province
Mazandaran
Postal code
4847193698
Phone
+98 11 3354 3695
Email
emrapharm@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Emran Habibi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Pharmacognosy
Street address
School of Pharmacy, Farah Abad
City
Sari
Province
Mazandaran
Postal code
4847193698
Phone
+98 11 3354 3695
Email
emrapharm@yahoo.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