Immunomodulatory effect of an herbal supplement containing Fenugreek, Nigella sativa and Sumac in patients with type 2 diabetes
Design
Double-blind clinical trial, 72 patients, 2 parallel groups by simple randomization.The trial phase is 3.
Settings and conduct
Patients visiting a center of traditional medicine clinic in Arak are divided into 2 groups by simple randomization with envelopes.The study is double-blind. Outcome elevator and analyzer and participant are blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria: fasting blood sugar is equal to or higher than 126 milligram per millilitre; taking oral hypoglycemic drugs; consumption of a fixed dose of oral hypoglycemic drugs for at least the last 3 months; lack of kidney failure; lack of type 1 diabetes; lack of acute and chronic inflammatory diseases; lack of malignancy; lack of drug addiction; no pregnancy or lactation. Exclusion criteria: dissatisfaction.
Intervention groups
Intervention group: In addition to the usual treatments for diabetes we treat patients with 6 capsules containing 3 Nigella sativa daily at a dose of 170 milligram, Fenugreek with a dose of 170 milligram, and Sumac with a dose of 170 milligram. Control group: In addition to conventional diabetes treatments, the placebo group will receive 6 capsules containing wheat flour containing 500 milligram for 6 weeks under the supervision of a traditional medicine specialist.
Main outcome variables
cytokine TGF-β; cytokine TNFɑ; cytokine IFN-γ; Cytokine IL-17; Number of Treg cells; Nitric oxide measurement
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141209020258N144
Registration date:2020-06-27, 1399/04/07
Registration timing:registered_while_recruiting
Last update:2020-06-27, 1399/04/07
Update count:0
Registration date
2020-06-27, 1399/04/07
Registrant information
Name
Fariba Farokhi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3222 2003
Email address
f.farokhi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-05, 1399/02/16
Expected recruitment end date
2021-05-06, 1400/02/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Immunomodulatory effect of an herbal supplement containing Fenugreek, Nigella sativa and Sumac in patients with type 2 diabetes
Public title
Immunomodulatory effect of an herbal supplement containing Fenugreek, Nigella sativa and Sumac in patients with type 2 diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Fasting blood sugar is equal to or higher than 126 milligram per millileter
Taking oral hypoglycemic drugs
Consumption of a fixed dose of oral hypoglycemic drugs for at least the last 3 months
Lack of kidney failure
Lack of type 1 diabetes
Lack of acute and chronic inflammatory diseases
Lack of malignancy
Lack of drug addiction
No pregnancy or lactation
Exclusion criteria:
Dissatisfaction
Age
From 25 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
Simple individual randomization with randomization with envelopes in 4 groups A and B .
In this method, we write a few cards or letters as intervention groups and the same number of cards for the control group, then the cards are mixed. One card is taken out and its allocation is registered and the card is returned to the other cards after leaving. Then the cards are mixed again and then another card is picked up. This process continues to reach a random sequence according to sample size.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is double blind. Outcome elevator and analyzer and participant are blind. Outcome elevator and analyzer and participant don't aware from grouping.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics comittee of Arak University of Medical Sciences
Street address
Ethics comittee, Research center, Payambar Azam complex, Basij squre, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3848176941
Approval date
2020-05-03, 1399/02/14
Ethics committee reference number
IR.ARAKMU.REC.1399.043
Health conditions studied
1
Description of health condition studied
Type II diabetes
ICD-10 code
E08
ICD-10 code description
Diabetes mellitus due to underlying condition
Primary outcomes
1
Description
Cytokine TGF-β
Timepoint
Before intervention and 6 weeks after the treatment
Method of measurement
Blood test
2
Description
Cytokine TNFɑ
Timepoint
Before intervention and 6 weeks after the treatment
Method of measurement
Blood test
3
Description
Cytokine IFN-γ
Timepoint
Before intervention and 6 weeks after the treatment
Method of measurement
Blood test
4
Description
Cytokine IL-17
Timepoint
Before intervention and 6 weeks after the treatment
Method of measurement
Blood test
5
Description
Number of Treg cells
Timepoint
Before intervention and 6 weeks after the treatment
Method of measurement
Blood test
6
Description
Nitric oxide measurement
Timepoint
Before intervention and 6 weeks after the treatment
Method of measurement
Blood test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In addition to the usual treatments for diabetes we treat patients with 6 capsules containing 3 Nigella sativa daily at a dose of 170 milligram, Fenugreek with a dose of 170 milligram, and Sumac with a dose of 170 milligram.
Category
Treatment - Drugs
2
Description
Control group: In addition to conventional diabetes treatments, the placebo group will receive 6 capsules containing wheat flour containing 500 milligram for 6 weeks under the supervision of a traditional medicine specialist.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Traditional Medicine Clinic
Full name of responsible person
Dr Mehdi Salehi
Street address
Emam reza clinic, Shahid Shirodi street
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3222 2003
Email
m.salehi@arakmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Alireza Kamali
Street address
Research Center, Payambar Azam Complex, Basij square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
alikamaliir@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?