Efficacy of NOSHINtrial in Diabetic Patients

NCT06205030 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: 402000209
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Diabetes Mellitus, Type 2; Insulin Resistance

Keywords

Type 2; Diabetes mellitus; Insulin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• plasma MDA

  40 days

• plasma protein carbonyl

  40 days

• plasma TAC

  40 days

• plasma SOD enzyme activity

  40 days

• plasma catalase enzyme activity

  40 days

Other Outcomes (16)

• WBC count

  40 days

• RBC count

  40 days

• Hemoglobin

  40 days

Study Arms (2)

NOSHIN SHAHD drug

ACTIVE COMPARATOR

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

placebo

PLACEBO COMPARATOR

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

Interventions

anti-diabetic herbal drug 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.

Also known as: NOSHIN SHAHD drug

NOSHIN SHAHD drug; placebo

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 20 and 65 years
• HbA1c more than 6.5
• Consistency of diet and exercise program
• Body mass index less than 35
• Not receiving insulin
• The patient should take standard medicine except insulin

You may not qualify if:

• Performing CABG surgery, occurrence of ASC, heart and brain stroke, pulmonary embolism, deep vein thrombosis or TIA in the last 1 year.
• 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.
• Presence of cancer, liver and thyroid diseases.
• pregnancy
• Smoking and alcohol consumption

Sponsors & Collaborators

• Kerman Medical University: lead
• Afzalipour Hospital: collaborator

Study Sites (1)

Kerman University of Medical Sciences

Kerman, Iran

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Insulin Resistance; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Anti-diabetic herbal and placebo syrups with the same color, shape, and box but different codes in two groups A and B are employed. After enrollment, each patient is allocated a code. Patients, researchers, and physicians who collect information in this study, assess outcomes, and analyze data for the study are blinded to the assigned treatment (anti-diabetic herbal or placebo) so that all patients are evaluated using their specific assigned code and treatment groups A or B.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Model Details: All the volunteers who meet the entry criteria were directed to the laboratory 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. they 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.

Study Record Dates

• First Submitted: December 19, 2023
• First Posted: January 12, 2024
• Study Start: September 26, 2025
• Primary Completion (Estimated): July 16, 2027
• Study Completion (Estimated): August 16, 2027
• Last Updated: August 26, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Access to study documentation after results are published.
• 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.

Locations

IR (1)