Efficacy of NOSHINtrial in Diabetic Patients
NCT06205030 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 70
Last updated 2025-08-26
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
Interventions
- 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.
Sponsors & Collaborators
-
Afzalipour Hospital
collaborator OTHER -
Kerman Medical University
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 20 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-09-26
- Primary Completion
- 2027-07-16
- Completion
- 2027-08-16
Countries
- Iran
Study Locations
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