Efficacy of NOSHINtrial in Diabetic Patients (NOSHIN)

August 6, 2026 updated by: Faegheh Bahri, Kerman Medical University

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
70

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iran
      • Kerman, Iran
        • Kerman University of Medical Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
HOMA-estimated insulin resistance
Time Frame: 40 days
To investigate the effect of the anti-diabetic herbal drug on changes in HOMA-IR in patients with T2DM
40 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
plasma MDA
Time Frame: 40 days
Investigating the changes in plasma Malondialdehyde level as an oxidative stress factor
40 days
plasma protein carbonyl
Time Frame: 40 days
Investigating the changes in plasma protein carbonyl level as an oxidative stress factor
40 days
plasma TAC
Time Frame: 40 days
Investigating the changes in plasma total antioxidant capacity as an oxidative stress factor
40 days
plasma SOD enzyme activity
Time Frame: 40 days
Investigating the changes in plasma SOD enzyme activity as an oxidative stress factor
40 days
plasma catalase enzyme activity
Time Frame: 40 days
Investigating the changes in plasma catalase enzyme activity as an oxidative stress factor
40 days
plasma reduced glutathione
Time Frame: 40 days
Investigating the changes in plasma reduced glutathione levels as an oxidative stress factor
40 days
ROS in PBMCs
Time Frame: 40 days
Investigating the changes in ROS level in PBMCs as an oxidative stress factor
40 days
FBS
Time Frame: 40 days
Investigating the changes in fasting blood glucose as a glycemic status
40 days
fasting blood Insulin
Time Frame: 40 days
Investigating the changes in fasting blood Insulin as a glycemic status
40 days
HbA1c
Time Frame: 40 days
Investigating the changes in HbA1c level as a glycemic status
40 days
Inflammatory biomarkers
Time Frame: 40 days
Investigating the changes in plasma TNF-α, IL-6, IL-1β, and hs-CRP levels
40 days

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
WBC count
Time Frame: 40 days
Investigating the changes in White blood cell counts as hematopoietic status
40 days
RBC count
Time Frame: 40 days
Investigating the changes in Red blood cell counts as a hematopoietic status
40 days
Hemoglobin
Time Frame: 40 days
Investigating the changes in hemoglobin level as a hematopoietic status
40 days
Hematocrit
Time Frame: 40 days
Investigating the changes in hematocrit level as a hematopoietic status
40 days
blood MCV
Time Frame: 40 days
Investigating the changes in amount of MCV level as a hematopoietic status
40 days
blood MCH
Time Frame: 40 days
Investigating the changes in amount of MCH level as a hematopoietic status
40 days
blood MCHC
Time Frame: 40 days
Investigating the changes in amount of MCHC level as a hematopoietic status
40 days
serum Urea
Time Frame: 40 days
Investigating the changes in serum Urea level as a biochemistry factor
40 days
serum Uric acid
Time Frame: 40 days
Investigating the changes in serum Uric acid level as a biochemistry factor
40 days
serum Creatinine
Time Frame: 40 days
Investigating the changes in serum Creatinine level as a biochemistry factor
40 days
BUN
Time Frame: 40 days
Investigating the changes in Blood urea nitrogen level as a biochemistry factor
40 days
Total protein
Time Frame: 40 days
Investigating the changes in total protein level as a biochemistry factor
40 days
Albumin
Time Frame: 40 days
Investigating the changes in Albumin level as a biochemistry factor
40 days
ALT
Time Frame: 40 days
Investigating the changes in Alanine transaminase level as a biochemistry factor
40 days
AST
Time Frame: 40 days
Investigating the changes in Aspartate Aminotransferase level as a biochemistry factor
40 days
lipid profile
Time Frame: 40 days
Investigating the changes in serum triglyceride, LDL cholesterol, HDL cholesterol, and Total cholesterol levels
40 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kerman Medical University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Afzalipour Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 26, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 16, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 26, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 19, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 3, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 12, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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