Efficacy of NOSHINtrial in Diabetic Patients (NOSHIN)

Efficacy of a Traditional Anti-diabetic Herbal Drug on Glycemic, Inflammatory, and Oxidative Stress Parameters in Patients With Type 2 Diabetes

The goal of this [Efficacy of a traditional anti-diabetic herbal drug with on glycemic, inflammatory, and oxidative stress parameters] is [investigate the level of HOMA-estimated insulin resistance as the primary outcome before and after 40 days in intervention and placebo groups] in [patients with type 2 diabetes]. The secondary outcomes of this study are the assessment of oxidative stress, inflammation biomarkers, other glycemic indices, hematopoietic status and lipid profile between the two groups before and after the intervention. also The food frequency questionnaire (FFQ) and the physical activity questionnaire (FAQ) are used to evaluate the effect of potential confounding factors. This study has the code of ethics IR.KMU.REC.1402.291 from Kerman University of Medical Sciences and this drug has the number 12/14484 from Iran Food and Drug Administration (IFDA).

Study Overview

• Status: Not yet recruiting
• Conditions: Diabetes Mellitus, Type 2; Insulin Resistance
• Intervention / Treatment: Drug: anti-diabetic herbal drug

Detailed Description

All the volunteers (Diabetic men and women with HbA1c more than 6.5 from the age of 20 to 65 years who usually use their standard medicine) who meet the entry criteria were directed to the laboratory and imaging center so that biochemical tests can be performed on them before taking the drug. Volunteers are asked to take the received medicine three times a day after food. It is worth mentioning that the patients will be divided into two groups by a person outside the research team, one group will drink herbal syrup and the other group will receive a placebo. A placebo with the same appearance as herbal syrup will drink nectar. On a weekly basis, the researcher will make phone calls with the applicants and, while reminding and recording the amount of herbal syrup consumed by drinking nectar, will also ask about the possible side effects of consuming herbal syrup drinking nectar. Then, at the end of the six week, the patient was asked to visit the clinic for a final evaluation. In this stage, the patient is asked about possible side effects, and the last stage of sample collection will be done to review all the tests of the next stage of receiving the drug (biochemical tests). Return at the end of week 6. The sample size in this study is 70 people.

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Phase 4

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Kerman, Iran, Islamic Republic of
    • Kerman University of Medical Sciences
    • Contact: Hossein Pourghadamyari, PhD; Phone Number: +98 913 379 9109; Email: ghadamyarih91@gmail.com
    • Contact: Faegheh Bahri, PhD; Phone Number: 09361261331; Email: faegheh.bahri9797@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Age between 20 and 65 years
2. HbA1c more than 6.5
3. Consistency of diet and exercise program
4. Body mass index less than 35
5. Not receiving insulin
6. The patient should take standard medicine except insulin

Exclusion Criteria:

1. Performing CABG surgery, occurrence of ASC, heart and brain stroke, pulmonary embolism, deep vein thrombosis or TIA in the last 1 year.
2. Taking anti-inflammatory drugs such as aspirin with an anti-inflammatory dose, antioxidant supplements, vitamins and omega-3 capsules (<1 g/day), and immunosuppressive drugs in the last three months.
3. Presence of cancer, liver and thyroid diseases.
4. pregnancy
5. Smoking and alcohol consumption

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: NOSHIN SHAHD drug; All the volunteers directed to the laboratory so that biochemical tests can be performed on them before taking the drug. Volunteers are asked to take the received NOSHIN SHAHD drug 20 ml three times per day after food. at the end of the six week. then, the sample collection will be done to review all the tests of the end stage of receiving the drug.	Drug: anti-diabetic herbal drug; All the volunteers directed to the laboratory so that biochemical tests can be performed on them before taking the drug. Volunteers are asked to take the received NOSHIN SHAHD drug 20 ml three times per day after food. at the end of the six week. then, the sample collection will be done to review all the tests of the end stage of receiving the drug.; Other Names: NOSHIN SHAHD drug
Placebo Comparator: placebo; The placebo with the same appearance as the herbal syrup will be drinking nectar. All the volunteers directed to the laboratory so that biochemical tests can be performed on them before taking the drug. Volunteers are asked to take the received placebo 20 ml three times per day after food. at the end of the six week. then, the sample collection will be done to review all the tests of the end stage of receiving the drug.	Drug: anti-diabetic herbal drug; All the volunteers directed to the laboratory so that biochemical tests can be performed on them before taking the drug. Volunteers are asked to take the received NOSHIN SHAHD drug 20 ml three times per day after food. at the end of the six week. then, the sample collection will be done to review all the tests of the end stage of receiving the drug.; Other Names: NOSHIN SHAHD drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HOMA-estimated insulin resistance	To investigate the effect of the anti-diabetic herbal drug on changes in HOMA-IR in patients with T2DM	40 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
plasma MDA	Investigating the changes in plasma Malondialdehyde level as an oxidative stress factor	40 days
plasma protein carbonyl	Investigating the changes in plasma protein carbonyl level as an oxidative stress factor	40 days
plasma TAC	Investigating the changes in plasma total antioxidant capacity as an oxidative stress factor	40 days
plasma SOD enzyme activity	Investigating the changes in plasma SOD enzyme activity as an oxidative stress factor	40 days
plasma catalase enzyme activity	Investigating the changes in plasma catalase enzyme activity as an oxidative stress factor	40 days
plasma reduced glutathione	Investigating the changes in plasma reduced glutathione levels as an oxidative stress factor	40 days
ROS in PBMCs	Investigating the changes in ROS level in PBMCs as an oxidative stress factor	40 days
FBS	Investigating the changes in fasting blood glucose as a glycemic status	40 days
fasting blood Insulin	Investigating the changes in fasting blood Insulin as a glycemic status	40 days
HbA1c	Investigating the changes in HbA1c level as a glycemic status	40 days
Inflammatory biomarkers	Investigating the changes in plasma TNF-α, IL-6, IL-1β, and hs-CRP levels	40 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
WBC count	Investigating the changes in White blood cell counts as hematopoietic status	40 days
RBC count	Investigating the changes in Red blood cell counts as a hematopoietic status	40 days
Hemoglobin	Investigating the changes in hemoglobin level as a hematopoietic status	40 days
Hematocrit	Investigating the changes in hematocrit level as a hematopoietic status	40 days
blood MCV	Investigating the changes in amount of MCV level as a hematopoietic status	40 days
blood MCH	Investigating the changes in amount of MCH level as a hematopoietic status	40 days
blood MCHC	Investigating the changes in amount of MCHC level as a hematopoietic status	40 days
serum Urea	Investigating the changes in serum Urea level as a biochemistry factor	40 days
serum Uric acid	Investigating the changes in serum Uric acid level as a biochemistry factor	40 days
serum Creatinine	Investigating the changes in serum Creatinine level as a biochemistry factor	40 days
BUN	Investigating the changes in Blood urea nitrogen level as a biochemistry factor	40 days
Total protein	Investigating the changes in total protein level as a biochemistry factor	40 days
Albumin	Investigating the changes in Albumin level as a biochemistry factor	40 days
ALT	Investigating the changes in Alanine transaminase level as a biochemistry factor	40 days
AST	Investigating the changes in Aspartate Aminotransferase level as a biochemistry factor	40 days
lipid profile	Investigating the changes in serum triglyceride, LDL cholesterol, HDL cholesterol, and Total cholesterol levels	40 days

Collaborators and Investigators

• Sponsor: Kerman Medical University
• Collaborators: Afzalipour Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): June 14, 2024
• Primary Completion (Estimated): February 16, 2025
• Study Completion (Estimated): July 16, 2025

Study Registration Dates

• First Submitted: December 19, 2023
• First Submitted That Met QC Criteria: January 3, 2024
• First Posted (Actual): January 12, 2024

Study Record Updates

• Last Update Posted (Estimated): January 17, 2024
• Last Update Submitted That Met QC Criteria: January 12, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Insulin; Diabetes mellitus; Type 2
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism; Diabetes Mellitus; Diabetes Mellitus, Type 2; Insulin Resistance; Physiological Effects of Drugs; Hypoglycemic Agents
• Other Study ID Numbers: 402000209

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: A part of the data such as the information related to the main outcome or the like can be shared. Access to study documentation after results are published and It will be available for researchers working in academic and scientific institutions, and also people who are working in the industry can apply for them for secondary studies. The request sent will be reviewed by the members of the center. If the members agree, they will be notified.
• IPD Sharing Time Frame: Access to study documentation after results are published.
• IPD Sharing Access Criteria: It will be available for researchers working in academic and scientific institutions, and also people who are working in the industry can apply for them for secondary studies.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No