CTRI/2021/07/034675Completed未知
A Prospective, Randomized, Open-label, Clinical Study to Evaluate the Efficacy and Safety of Mulmina D Mango (Low Calorie) to Demonstrate Antioxidant and Immunity Boosting Activities in DiabetesPatients With Standard of Care Treatment
Jagdale HealthCare0 sites100 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- 未知
- Status
- Completed
- Sponsor
- Enrollment
- 100
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility 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
- •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
Investigators
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