A clinical trial to determine the Efficacy and Safety of Succare in patients with diabetes mellitus (Type 1 and Type 2)
- Conditions
- Health Condition 1: null- Diabetes mellitus (Type 1 and Type 2)Health Condition 2: E11- Type 2 diabetes mellitus
- Registration Number
- CTRI/2014/01/004311
- Lead Sponsor
- atural Solutions
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
Aged 30 to 65 years
Male and female patients with diabetes mellitus with/without CKD.
Patients with inadequate glucose control on/not on any anti diabetic drugs
Body mass index between 20-35 kg/m2
In case of CKD patients as per PI discretion:
I. eGFR<=90 ml/min and >= 70 ml/min
II. Presence of protein and Blood in the Urine Having fasting blood glucose > 126 mg/dL
Post prandial blood glucose > 200 mg/dL
Having no serious physical or biochemical abnormalities other than those generally associated with diabetes mellitus (Type 1 and Type 2)
Patient is willing and able to comply with all trial requirements Ability to understand the Informed Consent and Willing to Sign on informed consent accordance with GCP and local legislation. Patients able to understand and follow the protocol of the trial.
Participants who are able to visit the medical institutions throughout the study period.
Patients having diabetes other than Insulin dependent & non insulin dependent diabetes mellitus.
Having history of hypersensitivity, liver or kidney damage or gastrointestinal disorders, acute infections, diseases of blood or hematopoietic organs
Pregnant or lactating women and patients receiving any concomitant medication, which may have interacted with hypoglycemic action of study drug. Subjects who are already taking or have taken in the past 2 months any investigational drug
Lack of suitability for participation in the trial, for any reason, as judged by PI History of HIV/HBS/HCV positive serology
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method