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

NCT07302178 | Not Yet Recruiting

• 1 other identifier: UMS-MOMORDICA-RCT2022
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Bitter melon extract; Momordica charantia; Channa striata; Glycemic status

Outcome Measures

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.

  Baseline and Week 4

Study Arms (2)

Combination of Snakehead Fish Powder + Bitter Melon Extract

EXPERIMENTAL

Participants in the experimental group will receive a combined herbal supplement containing Channa striata (snakehead fish) powder and Momordica charantia L. (bitter melon) extract. The supplement is provided in capsule form containing 500 mg per day, administered for 4 weeks.

Dietary Supplement: Snakehead Fish Powder + Bitter Melon Extract

Placebo Capsule

PLACEBO COMPARATOR

Participants in the control group will receive placebo capsules identical in appearance, administered once daily for 4 weeks, with no active herbal ingredients

Other: Placebo Capsule

Interventions

Placebo Capsule OTHER

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

Placebo Capsule

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

Combination of Snakehead Fish Powder + Bitter Melon Extract

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Currently using one class of oral antidiabetic medication (biguanide: metformin).
• Willing to participate and sign written informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitas Muhammadiyah Surakarta: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Hyperglycemia

Interventions

bitter melon extract

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• FIK UMS

  Universitas Muhammadiyah Surakarta

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fahrun Nur Rosyid, Doctoral degree

CONTACT

+62 8123183523; fnr100@ums.ac.id

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Both participants and study staff, including investigators and outcome assessors, will remain blinded to group allocation. The active supplement and placebo will be identical in appearance, packaging, and dosing schedule.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Quality Assurance Group

Model Details: A randomized, double-blind, placebo-controlled, parallel-group design evaluating the efficacy of a combined bitter melon extract and snakehead fish powder supplement compared with placebo for 4 weeks in adults with type 2 diabetes.

Study Record Dates

• First Submitted: December 11, 2025
• First Posted: December 24, 2025
• Study Start: January 1, 2026
• Primary Completion: February 28, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share