Kerman University of Medical Sciences
Kerman, Iran
Location contact
Faegheh Bahri, PhD
CONTACT
Hossein Pourghadamyari, PhD
CONTACT
NCT Number: NCT06205030
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).
Trial opening soon.
Get Notified20 year–65 year
All sexes
Interventional
Phase 4
Kerman, Iran
Faegheh Bahri, PhD
CONTACT
Hossein Pourghadamyari, PhD
CONTACT
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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.
Other names: NOSHIN SHAHD drug
Time frame: 40 days
To investigate the effect of the anti-diabetic herbal drug on changes in HOMA-IR in patients with T2DM
Time frame: 40 days
Investigating the changes in plasma Malondialdehyde level as an oxidative stress factor
Time frame: 40 days
Investigating the changes in plasma protein carbonyl level as an oxidative stress factor
Time frame: 40 days
Investigating the changes in plasma total antioxidant capacity as an oxidative stress factor
Time frame: 40 days
Investigating the changes in plasma SOD enzyme activity as an oxidative stress factor
Time frame: 40 days
Investigating the changes in plasma catalase enzyme activity as an oxidative stress factor
Time frame: 40 days
Investigating the changes in plasma reduced glutathione levels as an oxidative stress factor
Time frame: 40 days
Investigating the changes in ROS level in PBMCs as an oxidative stress factor
Time frame: 40 days
Investigating the changes in fasting blood glucose as a glycemic status
Time frame: 40 days
Investigating the changes in fasting blood Insulin as a glycemic status
Time frame: 40 days
Investigating the changes in HbA1c level as a glycemic status
Time frame: 40 days
Investigating the changes in plasma TNF-α, IL-6, IL-1β, and hs-CRP levels
Time frame: 40 days
Investigating the changes in White blood cell counts as hematopoietic status
Time frame: 40 days
Investigating the changes in Red blood cell counts as a hematopoietic status
Time frame: 40 days
Investigating the changes in hemoglobin level as a hematopoietic status
Time frame: 40 days
Investigating the changes in hematocrit level as a hematopoietic status
Time frame: 40 days
Investigating the changes in amount of MCV level as a hematopoietic status
Time frame: 40 days
Investigating the changes in amount of MCH level as a hematopoietic status
Time frame: 40 days
Investigating the changes in amount of MCHC level as a hematopoietic status
Time frame: 40 days
Investigating the changes in serum Urea level as a biochemistry factor
Time frame: 40 days
Investigating the changes in serum Uric acid level as a biochemistry factor
Time frame: 40 days
Investigating the changes in serum Creatinine level as a biochemistry factor
Time frame: 40 days
Investigating the changes in Blood urea nitrogen level as a biochemistry factor
Time frame: 40 days
Investigating the changes in total protein level as a biochemistry factor
Time frame: 40 days
Investigating the changes in Albumin level as a biochemistry factor
Time frame: 40 days
Investigating the changes in Alanine transaminase level as a biochemistry factor
Time frame: 40 days
Investigating the changes in Aspartate Aminotransferase level as a biochemistry factor
Time frame: 40 days
Investigating the changes in serum triglyceride, LDL cholesterol, HDL cholesterol, and Total cholesterol levels
Kerman Medical University
Other
Efficacy of a Traditional Anti-diabetic Herbal Drug on Glycemic, Inflammatory, and Oxidative Stress Parameters in Patients With Type 2 Diabetes
Acronym: NOSHIN
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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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