Health Condition 1: E139- Other specified diabetes mellituswithout complications
Conditions
Interventions
Intervention1: Mulmina D Mango: Dose: 400 mL (2 tetra pack of 200 mL each of investigational product
(IP) twice a day) for 30 days along with standard of care treatment.
Route of administration: Oral
Sponsors
Jagdale HealthCare
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Superoxide Dismutase (SOD) 2.Glutathione peroxidase 1 (GPX1) 3.Vitamin E (Alpha Tocopherol) 4.IgE 5.IgG 6.Natural Killer (NK) cells 7. high sensitive C-reactive protein (hs-CRP) Timepoint: Day 30 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Vitals 2. Hematology 3. Biochemistry 4. Fasting and Post prandial Blood Glucose 5. Urinalysis 6. 15D-Health-related quality of life (HRQOL) questionnaire 7. Occurrence of AE and SAEââ?¬â?¢sTimepoint: Day 30 | — |
Countries
India
Contacts
Public ContactSubham Dutta
Jagdale Industries Pvt Ltd
Outcome results
None listed