Clinical study on low calorie Mulmina D Mango in Diabetes Patients

Not Applicable

Completed

• Conditions: Health Condition 1: E139- Other specified diabetes mellituswithout complications

• Registration Number: CTRI/2021/07/034675
• Lead Sponsor: Jagdale HealthCare

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2021-12-11
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 100

Inclusion Criteria

1.Patients who have signed the written informed consent form approved by Ethics Committee after understanding explanations regarding the study.

2.Adult male and female, aged between 20 to 65 years (both inclusive)

3.Patients who have diagnosis of diabetes (according to American Diabetes Association [ADA] criteria) prior to study entry

4.Patients with diabetes on stable medications for the last 3 months before entering the study

Exclusion Criteria

1.The patients who have self-reported major diabetes complications, liver disease, kidney disease, or blood disorders

2.Are currently taking, or have taken within the 3 months preceding screening, medications to promote weight loss

3.Have had any episodes of severe hypoglycemia within 6 months prior to screening

4.Have had 1 or more episodes of ketoacidosis or

hyperosmolar state/coma in the 6 months prior to the study

5.Patients with uncontrolled hypertension and dyslipidemia (patients on stable medications in the last 3 months can be included).

6.Patients with thyroid disorders (Patients with hypothyroidism on stable dose of thyroxine for last 3 months can be included)

7.Patients with history of any cardiovascular events in the last 3 months.

8.Have self-reported cardiac disease with functional status that is New York Heart Association Class III or IV (per New York

Heart Association [NYHA] Cardiac Disease Classification)

9.Have a history of renal transplantation, or are currently receiving renal dialysis

10.Have had a blood transfusion or severe blood loss within 3 months prior to screening or have known hemoglobinopathy, hemolytic anemia or sickle cell anemia, or any other traits of hemoglobin abnormalities

11.Have active or untreated malignancy or have been in remission from clinically significant malignancy for less than 5 years

12.Female subjects who are pregnant (confirmed through Urine pregnancy test) or breastfeeding

13.Patients who participated in another clinical trial within 1 month before screening

14.Patients have any condition that in the judgement of investigator make the subject inappropriate for entry into this study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Superoxide Dismutase (SOD) <br/ ><br>2.Glutathione peroxidase 1 (GPX1) <br/ ><br>3.Vitamin E (Alpha Tocopherol) <br/ ><br>4.IgE <br/ ><br>5.IgG <br/ ><br>6.Natural Killer (NK) cells <br/ ><br>7. high sensitive C-reactive protein (hs-CRP) <br/ ><br>Timepoint: Day 30

Secondary Outcome Measures

Name	Time	Method
1. Vitals <br/ ><br>2. Hematology <br/ ><br>3. Biochemistry <br/ ><br>4. Fasting and Post prandial Blood Glucose <br/ ><br>5. Urinalysis <br/ ><br>6. 15D-Health-related quality of life (HRQOL) questionnaire <br/ ><br>7. Occurrence of AE and SAE�sTimepoint: Day 30