Combination of Bitter Melon Extract and Snakehead Fish Powder to Reduce Glycaemia in Type 2 Diabetes Mellitus
NCT ID: NCT07303127
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
80 participants
INTERVENTIONAL
2021-06-01
2021-10-01
Brief Summary
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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.
Detailed Description
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Bitter melon (Momordica charantia L.) has been traditionally used in various cultures as a natural remedy for diabetes. It contains several bioactive molecules, including alkaloids, flavonoids, catechins, saponins, charantins, and polypeptide-p, which are believed to contribute to glycemic regulation through mechanisms such as insulin secretagogue effects, enhancement of glucose utilization, modulation of glucose transporters, and inhibition of α-glucosidase activity. Despite its widespread traditional use, clinical findings have been variable due to differences in formulations, study durations, and methodological designs.
Snakehead fish (Channa striata) contains essential amino acids, fatty acids, and antioxidant components that may support metabolic processes and physiological recovery. While research has explored its nutritional and antioxidant potential, its combined use with bitter melon in T2DM has not been previously studied.
This study adopts a quasi-experimental design with a control group to assess the effect of a combined herbal supplement consisting of bitter melon extract and snakehead fish powder in individuals with T2DM. A total of 80 participants aged 25-65 years are recruited from four community health centers in Surakarta, Indonesia. Eligible participants have been clinically diagnosed with T2DM, are receiving metformin therapy, and meet specified biochemical inclusion criteria. Individuals with impaired renal or hepatic function, pregnancy, lactation, or known allergies to the study materials are excluded.
Participants provide informed consent and undergo initial screening before being allocated to either the treatment group or the placebo group. The intervention is administered for a period of four weeks. Outcome assessments include fasting plasma glucose, glycated albumin, insulin, and AGEs, measured at baseline and at the end of week four. Laboratory analyses utilize enzymatic methods and ELISA techniques. Medication adherence is monitored through pill counts and structured interviews during follow-up visits.
Throughout the study, participants are monitored for safety, tolerability, and any potential adverse events. This pilot study is intended to generate preliminary evidence on the feasibility and potential physiological effects of combining bitter melon extract and snakehead fish powder in the management of T2DM, and to inform the design of larger future clinical trials.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Intervention group
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.
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.
Control group
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
25 Years
65 Years
ALL
No
Sponsors
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Universitas Muhammadiyah Surakarta
OTHER
Responsible Party
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Fahrun Nur Rosyid
Head of Quality Assurance Group
Principal Investigators
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Faculty of Health Sciences FIK UMS
Role: PRINCIPAL_INVESTIGATOR
Universitas Muhammadiyah Surakarta
Locations
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Faculty of Health Sciences, Universitas Muhammadiyah Surakarta
Surakarta, Centre Java, Indonesia
Countries
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Other Identifiers
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UMS-MOMORDICA-RCT2025
Identifier Type: -
Identifier Source: org_study_id