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The effect of a traditional Iranian medicine product (fenugreek + black cumin + sumac + comfrey) on the control of blood sugar indicators in patients with type II diabetes compared to the placebo group

Protocol summary

Study aim
evaluate the effect of traditional-Iranian medicine (fenugreek + black cumin + sumac + comfrey) on blood sugar control in patients with type 2 diabetes.
Design
Clinical trial with a placebo group, with parallel groups, triple-blind, in 72 patients, randomized, stratified randomization based on BMI,
Settings and conduct
In this study, 72 patients with type 2 diabetes will be randomly assigned to two groups of 36. The intervention group will receive black seed, fenugreek seeds, sumac, and purslane, and the placebo group will receive capsules containing Oisel for 8 weeks. For the two groups with diabetes, the tests will be conducted in two stages, once at baseline and the second time after 8 weeks.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Use of oral hypoglycemic drugs (not insulin) Use of fixed doses of oral hypoglycemic drugs for at least the past 3 months No nutrition through enteral and parenteral No pregnancy and breastfeeding Individuals with a body mass index above 18.5 No kidney, liver, cardiovascular, thyroid and cancer disease Exclusion criteria: Allergy to the plants studied Following a special diet or taking the supplements Oral contraceptive pill
Intervention groups
In this study, 72 patients with type 2 diabetes were randomly selected and placed in two groups of 36 people randomly. The intervention group, in addition to common diabetes treatments, received 6 capsules daily containing 4 black seeds 2, fenugreek seeds 2, sumac 1, and purslane 1 in an amount of 500 mg, and the placebo group, in addition to common diabetes treatments, received 6 capsules daily containing 500 mg of Ovisel for 8 weeks.
Main outcome variables
Blood sugar indicators; blood lipids; liver enzymes

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20141027019705N5
Registration date: 2025-02-18, 1403/11/30
Registration timing: prospective

Last update: 2025-02-18, 1403/11/30
Update count: 0
Registration date
2025-02-18, 1403/11/30
Registrant information
Name
Mehdi Salehi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 3331 8165
Email address
m_salehi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-04-04, 1404/01/15
Expected recruitment end date
2026-03-11, 1404/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of a traditional Iranian medicine product (fenugreek + black cumin + sumac + comfrey) on the control of blood sugar indicators in patients with type II diabetes compared to the placebo group
Public title
Investigation of traditional-Iranian medicine(Nigella sativa , Trigonella foenum- graecum, Rhus coriaria , Portulaca oleracea ) products on blood sugar in type II diabetic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with type 2 diabetes FBS 2- Fasting blood sugar equal to or higher than 126 mg to 200 mg per deciliter or random sugar equal to or higher than 180 mg per deciliter HgbA1c: 6.5 to 9 - Use of oral hypoglycemic drugs (no insulin) No use of sulfonylurea drugs: Amaryl (Glimipride), Donil (Glibenclamide), Diamicron (Gilclazide), Minodiab (Glipizide), Tolbutamide, Tolazamide and glucocorticoids (Glipizide) Gilbenes Taking a fixed dose of oral hypoglycemic drugs for at least the past 3 months Not receiving enteral or parenteral nutrition Not pregnant or breastfeeding Individuals with a body mass index above 18.5 Not having kidney, liver, cardiovascular, thyroid or cancer disease aged 20 to 65 years old
Exclusion criteria:
Having a specific disease that could interfere with the study process Allergy to the plants studied Following a special diet or taking supplements Using Oral contraceptive pill
Age
From 20 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 72
Randomization (investigator's opinion)
Randomized
Randomization description
People with type 2 diabetes are divided equally into two intervention and control groups. By stratified randomization based on BMI (between 20 and 25, between 25 and 30, and greater than or equal to 30), people are placed in two intervention and control groups. People are matched between the intervention and control groups based on BMI.
Blinding (investigator's opinion)
Triple blinded
Blinding description
First, the participants are informed about the study. This study is a triple-blind study. The two groups, the drug and the placebo, are given identical capsules. And they are unaware of the contents of the capsules. In addition, the investigator, the analysis unit and/or the DSMB (Data and Safety Monitoring Board) are unaware of the type of intervention they are assigned to.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
The Research Ethics Committee of Arak University of Medical Sciences, Arak, Iran
Street address
e of Arak University of Medical Sciences, Arak, Iran
City
Arak
Province
Markazi
Postal code
8154794641
Approval date
2024-12-01, 1403/09/11
Ethics committee reference number
IR.ARAKMU.REC.1403.261

Health conditions studied

1

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

Primary outcomes

1

Description
fasting blood glucose
Timepoint
Before the intervention begins and at the beginning of the study, all subjects will have their blood sugar levels measured. After 8 weeks of administering the intervention, all subjects will be retested using the same method and at the same initial location, and the results will be compared.
Method of measurement
Fasting blood sugar is measured by enzymatic colorimetric method. Fasting insulin is measured by enzyme immunoassay method. The QUIKI index is used to calculate insulin sensitivity. To calculate the QUIKI index, fasting insulin is used in U/mlμ scale and fasting glucose is used in mg/dl scale: QUIKI = 1 / [log (FI) + log (FG)] To calculate insulin resistance, the HOMA-IR index is used. To calculate the HOMA-IR index, fasting insulin is used in U/lμ scale and fasting glucose is used in /l nmol scale: HOMA-IR = fasting insulin (μU/L) x fasting glucose (nmol/L)/22.5

2

Description
lipid profile
Timepoint
Before the intervention begins and at the beginning of the study, all individuals will be examined for their lipid profile, and after 8 weeks of administering the desired intervention, all individuals will be retested using the same method and at the same initial location for the second phase of testing, and the results will be compared.
Method of measurement
Serum cholesterol, LDL, HDL, TG are measured by colorimetric enzymatic method.

3

Description
liver enzume
Timepoint
Before the intervention begins and at the beginning of the study, all subjects' liver enzymes will be measured, and after 8 weeks of administering the desired intervention, all subjects will be retested using the same method and at the same initial location for the second phase of tests, and the results will be compared.
Method of measurement
AST, ALT, and ALP are measured by the colorimetric method.

Secondary outcomes

1

Description
Blood sugar indices
Timepoint
Before the intervention, that is, at the beginning of the study, patients will be evaluated for blood sugar. After 8 weeks from the start of the intervention, all individuals will be retested using the same method and at the same initial location for the second phase of tests, and the results will be compared.
Method of measurement
At the beginning and end of the study, FBS (fasting blood sugar), and fasting insulin, were measured after a 12-hour fast and two indices QUIKI and HOMA-IR were calculated. FBS was measured by the enzymatic colorimetric method. Fasting insulin was measured by the enzyme immunoassay method. The QUIKI index was used to calculate insulin sensitivity. To calculate the QUIKI index, fasting insulin was used in the U/mlμ scale and fasting glucose was used in the mg/dl scale:QUIKI = 1 / [log (FI) + log (FG)]The HOMA-IR index was used to calculate insulin resistance. To calculate the HOMA-IR index, fasting insulin in U/lμ and fasting glucose in nmol/l are used: HOMA-IR = fasting insulin (μU/L) x fasting glucose (nmol/L)/22.5

2

Description
lipid profile indices
Timepoint
Before the intervention, that is, at the beginning of the study, patients will be evaluated for lipid profile. After 8 weeks from the start of the intervention, all individuals will be retested using the same method and at the same initial location for the second phase of tests, and the results will be compared.
Method of measurement
At the beginning and end of the study, serum cholesterol, LDL, HDL, and TG are measured using the enzymatic colorimetric method.

3

Description
liver functional enzymes
Timepoint
Before the intervention, that is, at the beginning of the study, patients will be evaluated for liver functional enzymes. After 8 weeks from the start of the intervention, all individuals will be retested using the same method and at the same initial location for the second phase of tests, and the results will be compared.
Method of measurement
At the beginning and end of the study ALT, AST and Alp were measured after a 12-hour fast.. AST, ALT and ALP were measured by the colorimetric method.

Intervention groups

1

Description
Intervention group: The intervention group, under the supervision of a relevant specialist, in addition to common diabetes treatments, received 6 capsules daily containing 4 plants: black seed, fenugreek seeds, sumac, and purslane for 8 weeks.
Category
Treatment - Drugs

2

Description
Control group: Control group: The placebo group, in addition to common diabetes treatments, received 6 capsules containing Oisel daily for 8 weeks.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Shabani Diabetes Specialist Clinic
Full name of responsible person
Mehdi Salehi
Street address
Shahid Shabani Diabetes Specialist Clinic, Bagh zeresk, gharbagh, isfahan
City
Isfahan
Province
Isfehan
Postal code
3818134638
Phone
+98 918 364 8352
Email
m_salehi@razi.tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mehdi Salehi
Street address
Arak university of medical science
City
Arak
Province
Markazi
Postal code
3818134638
Phone
+98 918 364 8352
Email
m_salehi@razi.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Mehdi Salehi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Traditional Medicine
Street address
Arak university of medical science
City
Arak
Province
Markazi
Postal code
3818134638
Phone
+98 918 364 8352
Email
m_salehi@razi.tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mehdi Salehi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Traditional Medicine
Street address
Arak university of medical science
City
Arak
Province
Markazi
Postal code
3818134638
Phone
+98 918 364 8352
Email
m_salehi@razi.tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mehdi salehi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Traditional Medicine
Street address
Isfahan university of medical science
City
Arak
Province
Markazi
Postal code
3818134638
Phone
+98 918 364 8352
Email
M-salehi@razi.tums.ac.ir

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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
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