Nutritional, Metabolic, Endocrine
Conditions
Interventions
DBT57A
Sponsors
Kwame Nkrumah University of Science and Technology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Adults aged 20 to 65 years Clinical diagnosis of T2DM confirmed by fasting blood sugar greater than 7.0 mmol/L after a minimum 8-hour fast on at least two separate occasions Currently attending the Health for All Herbal Clinic and receiving DBT-57A as routine care Able to provide written informed consent Able to attend scheduled follow-up visits at Day 14 and Day 28
Exclusion criteria
Exclusion criteria: Confirmed Type 1 diabetes mellitus Current or recent use of insulin therapy or oral hypoglycaemic agents within one month before enrolment Established cardiovascular renal or hepatic disease Pregnancy or breastfeeding Concurrent use of conventional pharmaceutical medication with known interactions with herbal preparations Inability or unwillingness to provide informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in fasting blood sugar (FBS) from baseline to Day 28, measured in mmol/L using a calibrated glucometer (Accu-Chek Active, Roche Diagnostics) | — |
Secondary
| Measure | Time frame |
|---|---|
| Self-reported changes in diabetes-related symptoms including polyuria, polydipsia, nocturia, peripheral numbness, dizziness, and general body pain;Short-term safety and adverse event profile of DBT-57A including frequency, nature, and severity of adverse effects;Changes in body weight and blood pressure from baseline to Day 28;Association between participant age and fasting blood sugar at each measurement time point assessed using Pearson correlation coefficient | — |
Countries
Ghana
Contacts
Public ContactRudolph Mensah
Public Health Officer
Outcome results
None listed