Health Condition 1: E118- Type 2 diabetes mellitus with unspecified complications
Conditions
Interventions
Intervention1: JRK D-Co-D tablet + Metformin + Vidagliptin
Each tablet (500mg) contains
Nilavembu (Andrographis paniculata) : 100 mg
Naval (Syzygium cumini) : 50 mg
Seenthil (Tinospora cordifolia) :
Sponsors
Dr.JRKs Research and Pharmaceuticals Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. People who are clinically proven for diabetes mellitus (type 2) 2. The duration of the disease between -1-15 years with the age ranged between 35-70 years 3. Predominantly on Metformin +Vidagliptin treatment for last 5 months 4. Also consulting AYUSH vaid besides diabetologist for AYUSH supplements which is not been objected by the respective diabetologist 5. Willing to use JRK’s D-Co-D tablet as per the direction without altering or deviating the main line therapy (Metformin + Vidagliptin) 6. The patients who have not shown serious concern on any of the laboratory test parameters that may warrant the patient to be referred to specialized treatment 7. Patients who are willing to subject to certain laboratory investigations at entry level, 45 days, three and six month of therapy to ascertain treatment response 8. Patients who agree to the CRO and Sponsor to review and use the laboratory test results obtained purely for research purpose, without divulging the identity of the patient and where the medical benefit of JRK’s D-Co-D can be reached out to large section of patients in India and other countries 9. Patients who agree to consult the respective diabetologist without fail; where participation in the present observational study will not be construed by the patient such regular consultation of the diabetologist is not require
Exclusion criteria
Exclusion criteria: 1. Not agreed to any of the criteria mentioned above 2. Lactating female and pregnant women 3. Patients who may be suffering from infection, other health complications that may require primary medical attention
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Blood glucose profile of patients 2) Fasting blood glucose -FBG 3) Post prandial blood glucose -PPBG 4) Random blood glucose -RBG 5) Glycated haemoglobin -HbA1c 6) Na 7) K 8) Urea 9)Creatinine 10) Uric acid 11) Total protein 12) Albumin 13)Bilirubin 14) Alkaline phosphatase 15)Acid phosphatase 16)Amylase 17)Total cholesterol, 18) Triglyceride 19) Vit B12 20) Na in urine 21) K in urine 22)Creatinine in urine 23) Systolic and Diastolic blood pressureTimepoint: On day zero, after 45 days, after 3 months and after 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Patient and Investigator Feedbacks will be obtained 2) Adverse event monitoringTimepoint: On day zero, after 45 days, after 3 months and after 6 months | — |
Countries
India
Contacts
Public ContactGayathri Sivakumar
DK Elite Health Care Centre
Outcome results
None listed