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Clinical Trial Details

Trial ID: L2368
Source ID: NCT06205030
Associated Drug: Anti-Diabetic Herbal Drug
Title: Efficacy of NOSHINtrial in Diabetic Patients
Acronym: NOSHIN
Status: NOT_YET_RECRUITING
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2|Insulin Resistance
Interventions: DRUG: anti-diabetic herbal drug
Outcome Measures: Primary: 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: 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: 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
Sponsor/Collaborators: Sponsor: Kerman Medical University | Collaborators: Afzalipour Hospital
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 70
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2025-05-26
Completion Date: 2025-08-16
Results First Posted:
Last Update Posted: 2025-04-03
Locations: Kerman University of Medical Sciences, Kerman, Iran, Islamic Republic of
URL: https://clinicaltrials.gov/show/NCT06205030