Health Condition 1: null- Type 2 Diabetes Mellitus
Conditions
Interventions
Intervention1: Costus pictus extract 500 mg tablet: three tablets per day as a single dose 2 hour before lunch for 90 days
Intervention2: Costus pictus extract 500 mg tablet and Metformin
: Costus dos
Sponsors
Clinfound Clinical Research Services PvtLtd
Eligibility
Inclusion criteria
Inclusion criteria: Group A 1.Male or Female Patients aged 30-65 years 2.Patients newly diagnosed with diabetes with HbA1C >6.0% to 7.5%, FPG >126 mg/dL to 170 mg/dL, 2-hr OGTT = 200 mg/dL. 3. Patients not taking any allopathic medication or insulin (including herbal product) for management of diabetes since diagnosis 4. Able to do moderate intensity physical exercise and life style modification 5. Patients ready to give written informed consent and willing to comply the study protocol Inclusion Criteria –Group B 1. Male or Female Patients aged 30-65 years 2. Diagnosed Diabetic patients with HbA1C >6.5% to 11.0%, FPG >126 mg/dL to 200 mg/dL, 2-hr OGTT = 200 mg/dL. 3. Patients on Oral Hypoglycemic Agent Metformin. 4. Patients not taking any herbal product for management of diabetes since last 4 weeks. 5. Patients ready to give written informed consent and willing to comply the study protocol
Exclusion criteria
Exclusion criteria: Exclusion Criteria – Group A 1. Oral hypoglycemic agents or other anti-diabetic drugs 2. Antiplatelet, ACE Inhibitors, ARBs, Lipid lowering drugs 3. NASIDS (prolonged use for more than 10 days) 4. Any herbal supplement/ drug 5. Blood pressure: BP = 160/100 mmHg. 6. Any clinical history of cardiovascular disease,Liver, hormonal disorder or treatment. 7. History of peptic ulcer disease and/or GI bleeding/perforation 8. History of cancer 9. History or presence of proliferative retinopathy, severe non-proliferative retinopathy, macular edema or presence of untreated diabetic eye disease 10. History of treated peripheral or autonomic neuropathy 11. Pregnant or lactating females or absence of effective contraceptive methods for females of childbearing potential. 12. Patient with impaired kidney function (serum creatinine more than upper limit of normal) or liver function (serum transaminase more than 3 times upper limit of normal) 13. Presence of any severe medical or psychological condition or chronic condition/ inflammation/ infection that in the opinion of the investigator would compromise the patient’s safety or successful participation in the study. 14. Participation in any other clinical study within 30 days of screening. 15. Patients receiving any of the drugs within 3 months of screening or at the time of screening: 16. Systemic long acting corticosteroids (prolonged use for more than 10 days) or immunosuppressant 17. Conditions/criteria likely to interfere with participation and acceptance of randomized assignment, including the following: inability/unwillingness to give informed consent, major psychiatric or cognitive problems (schizophrenia, dementia), self-reported active illegal substance or alcohol abuse, and clinical judgment. Exclusion Criteria – Group B 1. Patients on any other diabetic drugs other than MetforminAntiplatelet, ACE Inhibitors, ARBs, Lipid lowering drugs 2. NASIDS (prolonged use for more than 10 days) 3. Any herbal supplement/ drug 4. Blood pressure: BP = 160/100 mmHg. 5. Any clinical history of cardiovascular disease,hormonal disorder or treatment. 6. History of peptic ulcer disease and/or GI bleeding/perforation 7. History of cancer 8. History or presence of proliferative retinopathy, severe non-proliferative retinopathy, macular edema or presence of untreated diabetic eye disease 9. History of treated peripheral or autonomic neuropathy 10. Pregnant or lactating females or absence of effective contraceptive methods for females of childbearing potential. 11. Patient with impaired kidney function (serum creatinine more than upper limit of normal) or liver function (serum transaminase more than 3 times upper limit of normal) 12. Presence of any severe medical or psychological condition or chronic condition/inflammation/infection that in the opinion of the investigator would compromise the patient’s safety or successful participation in the study. 13. Participation in any other clinical study within 30 days of screening. 14. Patients receiving any of the drugs within 3 months of screening or at the time of screening: 15. Systemic long acting corticosteroids (prolonged use for more th
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean percent change in FBS levels at the end of 90 days compared to baselineTimepoint: Day 1 Day 45 Day 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| S insulin levelsTimepoint: Day 1 Day 90;Biochemistry (Serum AST, ALT, and creatinine )Timepoint: Day 1 Day 90;C peptideTimepoint: Day 1 Day 90;HbA1c levelsTimepoint: Day 1 Day 90;Hematology (Hb, TLC, DLCs, PLC, ESR)Timepoint: Day 1 Day 90;Lipid ProfileTimepoint: Day 1 Day 90;OGTT (75gm glucose (apoA1)Timepoint: Day 1 Day 45 Day 90;Routine Urine ExaminationTimepoint: Day 1 Day 90;Urine Pregnancy testTimepoint: Day 1 Day 90 | — |
Countries
India
Contacts
Public ContactDr Sreejith Sreekumar
Arjuna Natural Extracts Limited
Outcome results
None listed