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NCT Number: NCT06205030

Efficacy of NOSHINtrial in Diabetic Patients

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).

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Key information

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Other names: NOSHIN SHAHD drug

Primary outcomes

  1. 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

Secondary outcomes

  1. plasma MDA

    Time frame: 40 days

    Investigating the changes in plasma Malondialdehyde level as an oxidative stress factor

  2. plasma protein carbonyl

    Time frame: 40 days

    Investigating the changes in plasma protein carbonyl level as an oxidative stress factor

  3. plasma TAC

    Time frame: 40 days

    Investigating the changes in plasma total antioxidant capacity as an oxidative stress factor

  4. plasma SOD enzyme activity

    Time frame: 40 days

    Investigating the changes in plasma SOD enzyme activity as an oxidative stress factor

  5. plasma catalase enzyme activity

    Time frame: 40 days

    Investigating the changes in plasma catalase enzyme activity as an oxidative stress factor

  6. plasma reduced glutathione

    Time frame: 40 days

    Investigating the changes in plasma reduced glutathione levels as an oxidative stress factor

  7. ROS in PBMCs

    Time frame: 40 days

    Investigating the changes in ROS level in PBMCs as an oxidative stress factor

  8. FBS

    Time frame: 40 days

    Investigating the changes in fasting blood glucose as a glycemic status

  9. fasting blood Insulin

    Time frame: 40 days

    Investigating the changes in fasting blood Insulin as a glycemic status

  10. HbA1c

    Time frame: 40 days

    Investigating the changes in HbA1c level as a glycemic status

  11. Inflammatory biomarkers

    Time frame: 40 days

    Investigating the changes in plasma TNF-α, IL-6, IL-1β, and hs-CRP levels

Other outcomes

  1. WBC count

    Time frame: 40 days

    Investigating the changes in White blood cell counts as hematopoietic status

  2. RBC count

    Time frame: 40 days

    Investigating the changes in Red blood cell counts as a hematopoietic status

  3. Hemoglobin

    Time frame: 40 days

    Investigating the changes in hemoglobin level as a hematopoietic status

  4. Hematocrit

    Time frame: 40 days

    Investigating the changes in hematocrit level as a hematopoietic status

  5. blood MCV

    Time frame: 40 days

    Investigating the changes in amount of MCV level as a hematopoietic status

  6. blood MCH

    Time frame: 40 days

    Investigating the changes in amount of MCH level as a hematopoietic status

  7. blood MCHC

    Time frame: 40 days

    Investigating the changes in amount of MCHC level as a hematopoietic status

  8. serum Urea

    Time frame: 40 days

    Investigating the changes in serum Urea level as a biochemistry factor

  9. serum Uric acid

    Time frame: 40 days

    Investigating the changes in serum Uric acid level as a biochemistry factor

  10. serum Creatinine

    Time frame: 40 days

    Investigating the changes in serum Creatinine level as a biochemistry factor

  11. BUN

    Time frame: 40 days

    Investigating the changes in Blood urea nitrogen level as a biochemistry factor

  12. Total protein

    Time frame: 40 days

    Investigating the changes in total protein level as a biochemistry factor

  13. Albumin

    Time frame: 40 days

    Investigating the changes in Albumin level as a biochemistry factor

  14. ALT

    Time frame: 40 days

    Investigating the changes in Alanine transaminase level as a biochemistry factor

  15. AST

    Time frame: 40 days

    Investigating the changes in Aspartate Aminotransferase level as a biochemistry factor

  16. lipid profile

    Time frame: 40 days

    Investigating the changes in serum triglyceride, LDL cholesterol, HDL cholesterol, and Total cholesterol levels

Sponsors and collaborators

Lead sponsor

Kerman Medical University

Other

Collaborators

  • Afzalipour Hospital

Registry information

Official study title

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

Acronym: NOSHIN

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 12, 2024
Registry last updated
Aug 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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