A clinical trial to study the effects of a herbal medicine "ADMO1 tablets" in patients with diabetes mellitus
- Conditions
- Health Condition 1: null- Diabetes mellitus type 2
- Registration Number
- CTRI/2010/091/006099
- Lead Sponsor
- Phyto Health Pharma B.V.P. O. Box 14, 2280AA Rijswijk, The NetherlandsTel: 0031 (0)70 300 2467Fax: 0031 (0)70 396 4147
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 120
?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.
?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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in HbA1c from baseline to end of treatmentTimepoint: Day 42 and Day 84
- Secondary Outcome Measures
Name Time Method Change in glycemic control parameters, lipid profile, oxidative and inflammatory markers from baselineTimepoint: FBS,PPBS: Baseline,Day 14,28,42,56,70,84<br>Lipid profile: Baseline,Day42, Day 84<br>Nitrotyrosine: Baseline and Day 84