Health Condition 1: null- Diabetes mellitus type 2
Conditions
Interventions
Intervention1: ADM01 tablets: Dose: 1 tab thrice daily
2 tab twice daily
3 tab twice daily. Duration: 84 days
Control Intervention1: Nil: Nil
Sponsors
Phyto Health Pharma B.V.
P. O. Box 14, 2280AA Rijswijk, The Netherlands
Tel: 0031 (0)70 300 2467
Fax: 0031 (0)70 396 4147
Eligibility
Inclusion criteria
Inclusion criteria: ? Patients with Type 2 diabetes mellitus (according to the American Diabetes Association criteria 2004). ? Patients with HbA1c 7-11 % ? Patients taking any stable daily dosage of oral hypoglycaemic agent (not more than 75 % of recommended maximal dose) for at least three months. ? Age between 20 and 70 years. ? Body Mass Index between 20 and 35 kg/m2. ? Patients willing to give written Informed consent and come for regular follow up.
Exclusion criteria
Exclusion criteria: ? Patients with type 2 diabetes who are difficult to control with respect to glucose homeostasis (non-stable patients), which will be decided by Investigator on clinical history of patients. ? Patients who, in addition to the oral anti hyperglycaemic drug also require insulin ? Patients who can be controlled by a changed life style (e.g. exercise, reduced body weight) ? Moderate or severe alcohol use (> than two drinks containing alcohol per day) ? Smoking more than 10 cigarettes per day ? Pregnant and nursing women ? Diabetic complications requiring treatment ? Serious hepatic or renal impairment ? Heart failure corresponding to NYHA class III or IV ? Known hypersensitivity or allergy to one or more of the herbal ingredients ? Recent (< 1 month) participation in a clinical trial ? Recent (< 1 month) use of any herbal/ayurvedic anti-diabetic drugs ? Significant cardiovascular co-morbidities, e.g. symptomatic heart failure, a history of ischemic heart disease, history of stroke and/or TIA ? Debilitating neurological or psychiatric disorders ? Any condition likely to hinder the compliance with the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in HbA1c from baseline to end of treatmentTimepoint: Day 42 and Day 84 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in glycemic control parameters, lipid profile, oxidative and inflammatory markers from baselineTimepoint: FBS,PPBS: Baseline,Day 14,28,42,56,70,84 Lipid profile: Baseline,Day42, Day 84 Nitrotyrosine: Baseline and Day 84 | — |
Countries
India
Contacts
Public ContactDr. Bhakti Shinde
Vedic Lifesciences Pvt Ltd.
Outcome results
None listed