Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: Helonias dioica 6C: Helonias dioica 6C, 4 medicated globules (#40 size), administered as a single dose sublingually every morning on an empty stomach. The medicine is to be stopped once
Sponsors
Department of Materia Medica White Memorial Homoeo Medical College and Hospital
Eligibility
Inclusion criteria
Inclusion criteria: Diagnosed with Type 2 Diabetes Mellitus according to ICMR 2018 diagnostic criteria. Either: 1) Newly diagnosed T2DM (diagnosed within the last 6 months) and entirely na ve to both oral anti-diabetic drugs (OADs) and insulin therapy, OR 2) Previously diagnosed T2DM but currently managed solely with diet and lifestyle modifications for at least the past 3 months (i.e., not on any OADs or insulin for at least 3 months). Baseline HbA1c between 6.5% and 8.0% (inclusive). Willing and able to provide written informed consent and adhere to study procedures.
Exclusion criteria
Exclusion criteria: Patients currently taking or having taken any conventional anti-diabetic medication (oral anti-diabetic drugs OR insulin) within the last 3 months. History of requiring continuous or long-term insulin therapy for glycaemic control. Type 1 Diabetes Mellitus, Latent Autoimmune Diabetes in Adults (LADA), Maturity Onset Diabetes of the Young (MODY), or secondary diabetes. Baseline HbA1c less than 6.5% or greater than 8.0%. Severe uncontrolled hypertension (systolic BP greater than 180 mmHg or diastolic BP greater than 110 mmHg despite medication). Presence of severe diabetic complications: proliferative retinopathy requiring active treatment, end-stage renal disease (eGFR less than 30 ml/min/1.73m ), active Charcot foot, major cardiovascular event within the last 6 months. Significant hepatic dysfunction (ALT or AST greater than 3 times the upper limit of normal). Known history of severe psychiatric illness that may interfere with informed consent or study compliance. Pregnant or lactating women, or women planning pregnancy during the study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in serum Glycated Hemoglobin (HbA1c) from baseline.Timepoint: 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change in Diabetes Symptom Checklist-Revised (DSC-R) total score from baseline.Timepoint: 3 months;Mean change in Fasting Blood Sugar (FBS) from baseline.Timepoint: 1 month, 2 months, and 3 months | — |
Countries
India
Contacts
Public ContactDR BINYA B V
White Memorial Homoeo Medical College
Outcome results
None listed