Combined Bitter Melon Extract and Snakehead Fish Powder Supplementation for Glycemic Control in Type 2 Diabetes
NCT07302178 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80
Last updated 2025-12-24
Summary
Type 2 diabetes mellitus (T2DM) remains a major global health problem due to its high prevalence, long-term complications, and substantial economic burden. Conventional antidiabetic therapies, including insulin and oral hypoglycemic agents, may cause significant side effects during long-term use and are contraindicated in certain clinical conditions. Therefore, safe and effective herbal-based alternatives are needed.
Previous preclinical and early clinical studies have shown that bitter melon (Momordica charantia L.) and snakehead fish (Channa striata) possess antidiabetic and anti-inflammatory properties, including improvement in glucose regulation, stimulation of insulin secretion, and regeneration of pancreatic cells. However, clinical evidence on their combined use remains limited.
This randomized, double-blind, placebo-controlled clinical trial aims to evaluate the effect of daily supplementation with a combination of bitter melon extract and snakehead fish powder on glycemic status in adults with Type 2 diabetes mellitus. Ninety eligible participants will be randomly assigned to a treatment group receiving 500 mg/day of the herbal combination or a placebo for 4 weeks. Glycemic status will be assessed primarily through glycated albumin (GA) levels.
The findings of this study are expected to provide scientific evidence regarding the safety and efficacy of this herbal combination as a complementary antidiabetic therapy.
Conditions
- Type 2 Diabetes Mellitus (T2DM)
- Hyperglycemia
Interventions
- DIETARY_SUPPLEMENT
-
Snakehead Fish Powder + Bitter Melon Extract
A 500 mg/day capsule containing a combination of: * Channa striata (snakehead fish) powder * Momordica charantia (bitter melon) ethanol extract Administered orally once daily for 4 weeks
- OTHER
-
Placebo Capsule
Capsule identical in size, shape, and color to the intervention capsule, without active ingredients. Administered orally once daily for 4 weeks.
Sponsors & Collaborators
-
Universitas Muhammadiyah Surakarta
lead OTHER
Principal Investigators
-
FIK UMS · Universitas Muhammadiyah Surakarta
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 20 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-01-01
- Primary Completion
- 2026-02-28
- Completion
- 2026-06-01
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