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Combination of Bitter Melon Extract and Snakehead Fish Powder to Reduce Glycaemia in Type 2 Diabetes Mellitus

NCT07303127 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2025-12-24

No results posted yet for this study

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.

Conditions

  • Type 2 Diabetes Mellitus (T2DM)

Interventions

DIETARY_SUPPLEMENT

Bitter Melon Extract and Snakehead Fish Powder Combination

Participants in the intervention group receive a combined herbal supplement consisting of bitter melon (Momordica charantia L.) extract and snakehead fish (Channa striata) powder. The supplement is prepared in capsule form at the Clinical Pharmacy Laboratory of Universitas Muhammadiyah Surakarta. Participants take the supplement daily for 4 weeks while continuing their routine metformin therapy. The formulation is standardized by maceration of bitter melon with ethanol followed by evaporation, and preparation of snakehead fish powder through steaming, drying, and milling before encapsulation.

OTHER

Placebo Capsule

Participants in the control group receive placebo capsules that are visually identical to the herbal supplement capsules. The placebo contains inert, non-active ingredients and is administered daily for 4 weeks. The placebo is designed to match the appearance and dosing schedule of the active supplement but contains no bitter melon extract or snakehead fish powder. Participants continue their routine metformin therapy during the study.

Sponsors & Collaborators

  • Universitas Muhammadiyah Surakarta

    lead OTHER

Principal Investigators

  • Faculty of Health Sciences FIK UMS · Universitas Muhammadiyah Surakarta

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-01
Primary Completion
2021-10-01
Completion
2021-10-01

Countries

  • Indonesia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07303127 on ClinicalTrials.gov