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

NCT07303127 | Completed

• 1 other identifier: UMS-MOMORDICA-RCT2025
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

AGEs; Bitter melon; Channa striata; Type 2 Diabetes Mellitus; Hypoglycaemic effect

Outcome Measures

Primary Outcomes (1)

• Fasting Plasma Glucose Level

  Fasting plasma glucose level measured using an enzymatic method to assess changes in glycemic status after 4 weeks of supplementation. Blood samples are collected after an overnight fast at baseline and at the end of the intervention

  Baseline and Week 4

Study Arms (2)

Intervention group

EXPERIMENTAL

Participants in this arm receive a combination supplement containing bitter melon (Momordica charantia L.) extract and snakehead fish (Channa striata) powder. The supplement is administered in capsule form for 4 weeks in addition to their routine metformin therapy.

Dietary Supplement: Bitter Melon Extract and Snakehead Fish Powder Combination

Control group

PLACEBO COMPARATOR

Participants in this arm receive placebo capsules designed to match the appearance of the herbal supplement. The placebo is administered for 4 weeks while participants continue their routine metformin therapy.

Other: Placebo Capsule

Interventions

Bitter Melon Extract and Snakehead Fish Powder Combination DIETARY_SUPPLEMENT

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.

Intervention group

Placebo Capsule OTHER

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.

Control group

Eligibility Criteria

• Age: 25 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 (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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitas Muhammadiyah Surakarta: lead

Study Sites (1)

Faculty of Health Sciences, Universitas Muhammadiyah Surakarta

Surakarta, Centre Java, 57162, Indonesia

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

bitter melon extract

Condition Hierarchy (Ancestors)

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

Study Officials

• Faculty of Health Sciences FIK UMS

  Universitas Muhammadiyah Surakarta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Not applicable. This study did not implement masking; both investigators and participants were aware of group assignments
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Quality Assurance Group

Model Details: A quasi-experimental parallel-group study in which participants are assigned to either the herbal supplement group or the placebo control group without randomization

Study Record Dates

• First Submitted: December 11, 2025
• First Posted: December 24, 2025
• Study Start: June 1, 2021
• Primary Completion: October 1, 2021
• Study Completion: October 1, 2021
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)