Efficacy of NOSHINtrial in Diabetic Patients

Diabetes Mellitus, Type 2 Clinical Trial

— NOSHIN  

Official title:

Efficacy of a Traditional Anti-diabetic Herbal Drug on Glycemic, Inflammatory, and Oxidative Stress Parameters in Patients With Type 2 Diabetes

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06205030
• Other study ID #: 402000209
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: June 14, 2024
• Est. completion date: July 16, 2025

Study information

• Verified date: January 2024
• Source: Kerman Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: July 16, 2025
• Est. primary completion date: February 16, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Age between 20 and 65 years

2. HbA1c more than 6.5

3. Consistency of diet and exercise program

4. Body mass index less than 35

5. Not receiving insulin

6. The patient should take standard medicine except insulin

Exclusion Criteria:

1. Performing CABG surgery, occurrence of ASC, heart and brain stroke, pulmonary embolism, deep vein thrombosis or TIA in the last 1 year.

2. Taking anti-inflammatory drugs such as aspirin with an anti-inflammatory dose, antioxidant supplements, vitamins and omega-3 capsules (<1 g/day), and immunosuppressive drugs in the last three months.

3. Presence of cancer, liver and thyroid diseases.

4. pregnancy

5. Smoking and alcohol consumption

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Insulin Resistance

Intervention

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.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Kerman University of Medical Sciences	Kerman

Sponsors (2)

Lead Sponsor	Collaborator
Kerman Medical University	Afzalipour Hospital

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	WBC count	Investigating the changes in White blood cell counts as hematopoietic status	40 days
Other	RBC count	Investigating the changes in Red blood cell counts as a hematopoietic status	40 days
Other	Hemoglobin	Investigating the changes in hemoglobin level as a hematopoietic status	40 days
Other	Hematocrit	Investigating the changes in hematocrit level as a hematopoietic status	40 days
Other	blood MCV	Investigating the changes in amount of MCV level as a hematopoietic status	40 days
Other	blood MCH	Investigating the changes in amount of MCH level as a hematopoietic status	40 days
Other	blood MCHC	Investigating the changes in amount of MCHC level as a hematopoietic status	40 days
Other	serum Urea	Investigating the changes in serum Urea level as a biochemistry factor	40 days
Other	serum Uric acid	Investigating the changes in serum Uric acid level as a biochemistry factor	40 days
Other	serum Creatinine	Investigating the changes in serum Creatinine level as a biochemistry factor	40 days
Other	BUN	Investigating the changes in Blood urea nitrogen level as a biochemistry factor	40 days
Other	Total protein	Investigating the changes in total protein level as a biochemistry factor	40 days
Other	Albumin	Investigating the changes in Albumin level as a biochemistry factor	40 days
Other	ALT	Investigating the changes in Alanine transaminase level as a biochemistry factor	40 days
Other	AST	Investigating the changes in Aspartate Aminotransferase level as a biochemistry factor	40 days
Other	lipid profile	Investigating the changes in serum triglyceride, LDL cholesterol, HDL cholesterol, and Total cholesterol levels	40 days
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
Secondary	plasma protein carbonyl	Investigating the changes in plasma protein carbonyl level as an oxidative stress factor	40 days
Secondary	plasma TAC	Investigating the changes in plasma total antioxidant capacity as an oxidative stress factor	40 days
Secondary	plasma SOD enzyme activity	Investigating the changes in plasma SOD enzyme activity as an oxidative stress factor	40 days
Secondary	plasma catalase enzyme activity	Investigating the changes in plasma catalase enzyme activity as an oxidative stress factor	40 days
Secondary	plasma reduced glutathione	Investigating the changes in plasma reduced glutathione levels as an oxidative stress factor	40 days
Secondary	ROS in PBMCs	Investigating the changes in ROS level in PBMCs as an oxidative stress factor	40 days
Secondary	FBS	Investigating the changes in fasting blood glucose as a glycemic status	40 days
Secondary	fasting blood Insulin	Investigating the changes in fasting blood Insulin as a glycemic status	40 days
Secondary	HbA1c	Investigating the changes in HbA1c level as a glycemic status	40 days
Secondary	Inflammatory biomarkers	Investigating the changes in plasma TNF-a, IL-6, IL-1ß, and hs-CRP levels	40 days