Combination of Bitter Melon Extract and Snakehead Fish Powder to Reduce Glycaemia in Type 2 Diabe… (NCT07303127) | Clinical Trial Compass
CompletedNot Applicable
Combination of Bitter Melon Extract and Snakehead Fish Powder to Reduce Glycaemia in Type 2 Diabetes Mellitus
Indonesia80 participantsStarted 2021-06-01
Plain-language summary
Type 2 Diabetes Mellitus (T2DM) is a chronic metabolic disorder characterized by persistent hyperglycemia, which contributes to the formation of advanced glycation end-products (AGEs) and increases the risk of long-term complications. Bitter melon (Momordica charantia L.) contains bioactive compounds that may support glycemic control, while snakehead fish (Channa striata) provides amino acids and fatty acids with potential antioxidant and restorative properties.
This study aims to evaluate the effect of a combined supplementation of bitter melon extract and snakehead fish powder on glycemic parameters in adults with T2DM. The study uses a quasi-experimental design with a control group, involving 80 participants recruited from community health centers in Surakarta, Indonesia. Participants are allocated to either a treatment group receiving the herbal combination or a control group receiving a placebo for four weeks.
Glycemic and biochemical parameters-including fasting plasma glucose, glycated albumin, insulin levels, and AGEs-are measured at baseline and at the end of the intervention period. Safety monitoring and adherence assessment are conducted throughout the study. This pilot investigation aims to explore the potential role of the combined supplement in the management of T2DM.
Who can participate
Age range
25 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Diagnosed with Type 2 Diabetes Mellitus (T2DM).
* Age 25-65 years.
* Currently treated with one type of biguanide (metformin).
* Fasting plasma glucose 126-200 mg/dL.
* Willing to participate and sign informed consent.
* Able to attend all study visits at participating health centers.
Exclusion Criteria:
* Positive pregnancy test or currently breastfeeding.
* Impaired renal function (creatinine \> 1.5 mg/dL).
* Impaired liver function (SGOT \> 40 U/L or SGPT \> 35 U/L, or ≥2× upper normal limit).
* Known allergy to bitter melon extract or snakehead fish powder.
* Any condition judged by investigators to interfere with study participation.
* Participants who withdraw consent or are unable to complete the intervention.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.