Efficacy of NOSHINtrial in Diabetic Patients

Sponsor
Kerman Medical University
Study ID
NCT06205030
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
20 Years - 65 Years
Healthy Volunteers
Accepted

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.

Study Details

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).

Key Dates

First listed
Jan 12, 2024
Start date
Sep 26, 2025
Status verified
Aug 2025
Primary completion
Jul 16, 2027
Completion
Aug 16, 2027

Study Design

Enrollment
70 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.

Primary Outcome Measure

HOMA-estimated insulin resistance [ Time Frame: 40 days ]

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