Diabetes Mellitus (DM)
Conditions
Interventions
Jena DM
Glucoplus
Glucotak
Standard of care
Sponsors
Science Technology and Innovation Secretariate Office of the President
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: A participant will be eligible for enrolment in this study if he or she meets the following criteria: Age = 18 years at the time of enrolment. History of a laboratory-confirmed diagnosis of diabetes mellitus made within the preceding three months. Naïve to herbal/natural/traditional therapeutic products for diabetes management. Capable of providing written informed consent, either personally or through a legally authorized representative/next of kin. Resident in Kampala, Wakiso, or Mukono districts to ensure feasibility of follow-up. Willing to adhere to study procedures and attend all scheduled follow-up visits. Has a medical record confirming a recent diabetic diagnosis (within the last three months).
Exclusion criteria
Exclusion criteria: A participant who meets the inclusion criteria will not be enrolled in this study if he or she meets any of the following conditions: Critically ill and requiring hospital admission at the time of screening. Pregnant women with diabetes mellitus (either pre-existing or gestational diabetes). Currently using or has recently used any herbal/natural/traditional therapeutic products for diabetes management. Unwilling or unable to provide written informed consent. Unlikely to adhere to study procedures or follow-up schedule (e.g., planning to relocate during the study period). Any medical or psychiatric condition that, in the opinion of the investigators, may compromise participant safety or interfere with study outcomes.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome of this clinical trial is the mean change in glycated hemoglobin (HbA1c) levels from baseline to the six-month follow-up time point, which will be compared across the four trial arms. This endpoint directly addresses the study's central hypothesis by measuring the glucose-lowering efficacy of the three investigational herbal products (Jena DM, Glucoplus, and Glucotak) when used as an adjunct to standard care. A change in HbA1c of 0.5% or more is considered clinically significant, providing a rigorous, standardized metric to determine if the addition of any herbal intervention leads to a meaningful improvement in long-term glycemic control compared to standard care alone. | — |
Secondary
| Measure | Time frame |
|---|---|
| The study's secondary outcomes encompass a comprehensive assessment of the interventions' effects on cardio-metabolic health and safety, including changes in body weight, blood pressure, lipid profile, and measures of pancreatic beta-cell function and insulin resistance. Safety will be rigorously monitored by tracking the proportion of participants experiencing adverse events, specifically hypoglycemia, gastrointestinal disturbances, and drug-related hospitalizations. Additionally, the pharmacokinetic profiles of the key marker compounds in each herbal product will be investigated to understand their absorption and metabolism in the body | — |
Countries
Uganda
Contacts
Public ContactMaria ;Karen Sekimpi;K.K. Ndahura
Trial Manager;Research Fellow
Outcome results
None listed