A Phase 4 interventional study of anti-diabetic herbal drug in Diabetes Mellitus, Type 2 and Insulin Resistance, sponsored by Kerman Medical University. Completed at 1 site in Iran. Open to participants aged 20 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-10.
Sponsored by Kerman Medical University · Phase 4, Interventional, and Treatment
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).
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.
9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.
This study's enrollment of 70 is below the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Kerman Medical University is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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
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
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
HOMA-estimated insulin resistance
To investigate the effect of the anti-diabetic herbal drug on changes in HOMA-IR in patients with T2DM
Time frame: 40 days
plasma MDA
Investigating the changes in plasma Malondialdehyde level as an oxidative stress factor
Time frame: 40 days
plasma protein carbonyl
Investigating the changes in plasma protein carbonyl level as an oxidative stress factor
Time frame: 40 days
plasma TAC
Investigating the changes in plasma total antioxidant capacity as an oxidative stress factor
Time frame: 40 days
plasma SOD enzyme activity
Investigating the changes in plasma SOD enzyme activity as an oxidative stress factor
Time frame: 40 days
plasma catalase enzyme activity
Investigating the changes in plasma catalase enzyme activity as an oxidative stress factor
Time frame: 40 days
plasma reduced glutathione
Investigating the changes in plasma reduced glutathione levels as an oxidative stress factor
Time frame: 40 days
ROS in PBMCs
Investigating the changes in ROS level in PBMCs as an oxidative stress factor
Time frame: 40 days
FBS
Investigating the changes in fasting blood glucose as a glycemic status
Time frame: 40 days
fasting blood Insulin
Investigating the changes in fasting blood Insulin as a glycemic status
Time frame: 40 days
HbA1c
Investigating the changes in HbA1c level as a glycemic status
Time frame: 40 days
Inflammatory biomarkers
Investigating the changes in plasma TNF-α, IL-6, IL-1β, and hs-CRP levels
Time frame: 40 days
WBC count
Investigating the changes in White blood cell counts as hematopoietic status
Time frame: 40 days
RBC count
Investigating the changes in Red blood cell counts as a hematopoietic status
Time frame: 40 days
Hemoglobin
Investigating the changes in hemoglobin level as a hematopoietic status
Time frame: 40 days
Hematocrit
Investigating the changes in hematocrit level as a hematopoietic status
Time frame: 40 days
blood MCV
Investigating the changes in amount of MCV level as a hematopoietic status
Time frame: 40 days
blood MCH
Investigating the changes in amount of MCH level as a hematopoietic status
Time frame: 40 days
blood MCHC
Investigating the changes in amount of MCHC level as a hematopoietic status
Time frame: 40 days
serum Urea
Investigating the changes in serum Urea level as a biochemistry factor
Time frame: 40 days
serum Uric acid
Investigating the changes in serum Uric acid level as a biochemistry factor
Time frame: 40 days
serum Creatinine
Investigating the changes in serum Creatinine level as a biochemistry factor
Time frame: 40 days
BUN
Investigating the changes in Blood urea nitrogen level as a biochemistry factor
Time frame: 40 days
Total protein
Investigating the changes in total protein level as a biochemistry factor
Time frame: 40 days
Albumin
Investigating the changes in Albumin level as a biochemistry factor
Time frame: 40 days
ALT
Investigating the changes in Alanine transaminase level as a biochemistry factor
Time frame: 40 days
AST
Investigating the changes in Aspartate Aminotransferase level as a biochemistry factor
Time frame: 40 days
lipid profile
Investigating the changes in serum triglyceride, LDL cholesterol, HDL cholesterol, and Total cholesterol levels
Time frame: 40 days
Plan to share: Yes — A part of the data such as the information related to the main outcome or the like can be shared. Access to study documentation after results are published and 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. The request sent will be reviewed by the members of the center. If the members agree, they will be notified.
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
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This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Kerman Medical University