Combined Bitter Melon Extract and Snakehead Fish Powder Supplementation for Glycemic Control in Type 2 Diabetes

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-65
SponsorUniversitas Muhammadiyah Surakarta

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosed with Type 2 Diabetes Mellitus (DMT2).

Fasting plasma glucose ≥ 126 mg/dL and ≤ 200 mg/dL or random blood glucose between 200-300 mg/dL.

Age 20-65 years

Duration of diabetes 0-15 years.

Disqualifiers

Pregnant or breastfeeding; or having impaired kidney or liver function (serum creatinine > 1.5 mg/dL; SGOT/SGPT > 2× upper limit).

Allergy to snakehead fish powder (Channa striata) or bitter melon extract (Momordica charantia).

Using antidiabetic medications other than metformin, or unable/unwilling to comply with study procedures.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Snakehead Fish Powder + Bitter Melon Extract

    Dietary supplement

    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

  • Placebo Capsule

    Other intervention

    Capsule identical in size, shape, and color to the intervention capsule, without active ingredients. Administered orally once daily for 4 weeks.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Combination of Snakehead Fish Powder + Bitter Melon ExtractExperimental treatment 1 intervention
Group B: Placebo CapsulePlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in Fasting Plasma Glucose (FPG) Level

Fasting plasma glucose level measured at baseline (week 0) and after 4 weeks of supplementation with the combination of Channa striata (snakehead fish powder) and Momordica charantia (bitter melon extract), compared with placebo.

Time frame
Baseline and Week 4

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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