Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion Criteria4: 1.Male& female subjects between the ages of 18 and 70 years, inclusive, with Type 2 diabetes mellitus as defined by the American Diabetes Association (Diabetes care, Vol. 21: S5- S19, 1998) for more than one year. 2.Blood sugar levels- a. Fasting- 120-150 mg/dl b. Post-prandial- 140-200 mg/dl 3.Random blood sugar level-140-200 mg/dl HbA1C 6-10mg%) 4.Subjects must be off all oral hypoglycemic agents during the entire duration of study with prior written consent. 5.Subjects must refrain from strenuous physical activity beginning 72 hours prior to admission and through the duration of the study. 6.Subjects must be willing and able to provide written informed consent
Exclusion criteria
Exclusion criteria: TYPE-1 DIABETES MELLITUS Subjects with â??brittleâ?? diabetes or predisposition to severe hypoglycemia, e.g., 2 or more serious hypoglycemic episodes (requiring anotherâ??s assistance) within the past year, or any hospitalization or emergency room visit due to poor diabetic control within the past 6 months Evidence of significant active hematological disease and/or cumulative blood donation of 1 unit (500 mL) or more including blood drawn during clinical trials in the last 3 months. Evidence of significant active neuropsychiatric disease. CHRONIC ALCOHOLIC Intake of any drug which in the evaluation of the investigator may interfere with the interpretation of trial results or are known to cause clinically relevant interference with insulin action, glucose utilisation or recovery from hypoglycemia. ON INSULIN THERAPY Have any other condition (including drug abuse, alcohol abuse, or psychiatric disorder) that, in the opinion of the investigator, precludes the patient from following and completing the protocol. History or presence of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, neurological or infectious disorders capable emerging as a potent risk factor when taking the study medication.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate and document the evidence-based efficacy and safety of the L.M.Potency versus Centesimal scale potency in lowering Blood sugar levels in type-II Diabetes mellitusTimepoint: To evaluate and document the evidence-based efficacy and safety of the L.M.Potency versus Centesimal scale potency in lowering Blood sugar levels in type-II Diabetes mellitus every 1 month | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the efficacy of the scales of potencies under study in relieving symptoms associated with Diabetes Mellitus.Timepoint: FOLLOW UP EVERY WEEK OR 15DAYS;To assess the improvement or changes, if any, in necessary investigations performed at the beginning and end of study especially Glycosylated Heamoglobin levels (HbA1C)Timepoint: EVERY 3 MONTHS | — |
Countries
India
Contacts
Dr. D.Y. Patil Homoeopathic Medical College & Research Centre, Pimpri, Pune