Type 2 Diabetes Mellitus (T2DM)NCT07303127
Combination of Bitter Melon Extract and Snakehead Fish Powder to Reduce Glycaemia in Type 2 Diabetes Mellitus
A study testing Bitter Melon Extract and Snakehead Fish Powder Combination in people with Type 2 Diabetes Mellitus (T2DM), run by Universitas Muhammadiyah Surakarta at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Type 2 Diabetes Mellitus (T2DM)
- What is being tested?
- Bitter Melon Extract and Snakehead Fish Powder Combination
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Jun 2021to 1 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Faculty of Health Sciences, Universitas Muhammadiyah Surakarta
Surakarta, Centre Java, 57162
About this study
Official title: Combination Effect of Bitter Melon (Momordica Charantia L.) Extract With Snakehead Fish (Channa Striata) Powder to Reduce the Glycaemia Increase in Type 2 Diabetes Mellitus
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.
Read the detailed description
Type 2 Diabetes Mellitus (T2DM) is a chronic metabolic condition marked by persistent hyperglycemia and associated inflammation, which contribute to the development of vascular and metabolic complications. Chronic hyperglycemia accelerates the formation of advanced glycation end-products (AGEs), which may impair tissue structure and function through oxidative stress and protein cross-linking mechanisms. Dietary phytochemicals and bioactive compounds have been increasingly studied as supportive strategies for glycemic regulation.
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
- Type 2 Diabetes Mellitus (T2DM)
- Being tested
- Bitter Melon Extract and Snakehead Fish Powder Combination, Placebo Capsule
- Keywords
- AGEs, Bitter melon, Channa striata, Type 2 Diabetes Mellitus, Hypoglycaemic effect
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bitter Melon Extract and Snakehead Fish Powder CombinationDietary 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.
Placebo CapsuleOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Placebo Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline and Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2025
- Study start1 Jun 2021
- Primary completion1 Oct 2021
- Study completion1 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes Mellitus (T2DM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- A quasi-experimental parallel-group study in which participants are assigned to either the herbal supplement group or the placebo control group without randomization
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Muhammadiyah Surakarta
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fahrun Nur Rosyid, Universitas Muhammadiyah Surakarta
- Investigators
- Faculty of Health Sciences FIK UMS, Principal investigator, Universitas Muhammadiyah Surakarta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07303127
- Sponsor's protocol ID
- UMS-MOMORDICA-RCT2025
- Status last verified
- Dec 2025
- First submitted
- 11 Dec 2025
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared because the study was conducted as a small pilot trial with limited sample size, and the informed consent obtained from participants did not include permission for public or external data sharing. Additionally, privacy protections and institutional policies restrict the distribution of raw participant-level data outside the research team.
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination Effect of Bitter Melon (Momordica Charantia L.) Extract With Snakehead Fish (Channa Striata) Powder to Reduce the Glycaemia Increase in Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT07303127
- Acronym / sponsor ID
- UMS-MOMORDICA-RCT2025
- Conditions
- Type 2 Diabetes Mellitus (T2DM)
- Keywords
- AGEs, Bitter melon, Channa striata, Type 2 Diabetes Mellitus, Hypoglycaemic effect
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Universitas Muhammadiyah SurakartaUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 24 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Type 2 Diabetes Mellitus (T2DM) is a chronic metabolic condition marked by persistent hyperglycemia and associated inflammation, which contribute to the development of vascular and metabolic complications. Chronic hyperglycemia accelerates the formation of advanced glycation end-products (AGEs), which may impair tissue structure and function through oxidative stress and protein cross-linking mechanisms. Dietary phytochemicals and bioactive compounds have been increasingly studied as supportive strategies for glycemic regulation.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A quasi-experimental parallel-group study in which participants are assigned to either the herbal supplement group or the placebo control group without randomization
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Dietary Supplement: Bitter Melon Extract and Snakehead Fish Powder CombinationParticipants 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. |
| Control group | Placebo comparator | Other: Placebo CapsuleParticipants 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. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bitter Melon Extract and Snakehead Fish Powder CombinationParticipants 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. | Dietary supplement | Intervention group |
| Placebo CapsuleParticipants 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. | Other | Control group |
Primary outcome
Fasting Plasma Glucose Level
Time frame: Baseline and Week 4
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared because the study was conducted as a small pilot trial with limited sample size, and the informed consent obtained from participants did not include permission for public or external data sharing. Additionally, privacy protections and institutional policies restrict the distribution of raw participant-level data outside the research team.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Faculty of Health Sciences FIK UMS principal investigator
Universitas Muhammadiyah Surakarta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bitter Melon Extract and Snakehead Fish Powder Combination in people with Type 2 Diabetes Mellitus (T2DM), run by Universitas Muhammadiyah Surakarta at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fasting Plasma Glucose Level (time frame: Baseline and Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2025.