Type2 DiabetesPhase 2NCT05439473
Evaluation of the Efficacy and Safety of Curalin as Add-On Therapy in Adults With Type 2 Diabetes Mellitus
A Phase 2 study testing Curalin in people with Type2 Diabetes, run by CuraLife at 1 site in Israel.
Trial summary
Evaluation of Efficacy and Safety of Curalin As Add-On Therapy in Adults With Type 2 Diabetes Mellitus Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Type2 Diabetes
- What is being tested?
- Curalin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteIsrael
- Study dates
- 3 Aug 2021to 1 May 2022
- Phase
- Phase 2
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent is obtained.
- Adult patients (18-85 years of age) with Type II diabetes mellitus.
- HbA1c at screening is 8% - 11%.
- Body mass index (BMI)>25.
- Stable body weight (±10%) within the 3 months preceding study entry.
- Patients were steadily treated with anti-diabetic medications, such as: GLP-1, Glucophage DPP-4 inhibitor or SGLT-2 inhibitor for at least 3 months or more prior to study entry.
- The patient must be willing and able to comply with study restrictions and to remain at the clinic for the required duration during the study period, and willing to return to the clinic for the follow up evaluation as specified in this protocol.
Who cannot join
- Patients who have been using Curalin
- Persons with known sensitivity to any of the components of the Curalin product.
- The patient has any clinically significant uncontrolled medical condition (treated or untreated).
- Patients with renal insufficiency (glomerular filtration rate [GFR]≤30 mL/min/1.73m2).
- Pregnant or lactating women. Women of child bearing potential will be administered a urine pregnancy test at study entry. All study participants will confirm their willingness to use birth control throughout the study.
- Patients deemed by the Investigator as unable to complete study participation.
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- Patients currently treated with insulin or those that have been treated with insulin for more than 10 days in the 3 months prior to study entry.
- Use of medications known to modify glucose metabolism or to decrease the ability to recover from hypoglycemia such as oral, parenteral, local, dermal and inhaled steroids, and immunosuppressive or immunomodulating agents for more than a month prior to study entry, or during the study.
- Patient participated in a clinical study (investigational study drug or study device) within 30 days of the study entry.
- Life expectancy less than 1 year.
- History of stroke, transient ischemic attack, or myocardial infarction within six months prior to screening.
- Patients with uncontrolled hypertension defined as a systolic blood pressure ≥180 mmHg or a diastolic blood pressure ≥100mmHg.
- Patients who have thyroid stimulating hormone (TSH) levels >1.5 times the upper limit of normal.
- Patients with significant liver disease or liver function impairment defined as any of the following; cirrhosis, hepatitis, biliary obstruction with hyperbilirubinemia (total bilirubin >2 times the upper limit of normal) and aspartate aminotransferase (AST) or alanine aminotransferase levels (ALT) >3 times the upper limit of normal.
- Patients with creatine kinase concentrations > 10 times the upper limit of normal or creatine kinase elevation due to known muscle disease at visit 1 (screening 1).
- Laboratory abnormalities at screening including:
- Potassium > 5.5 mEq/L
- Sodium ≤ 130 mEq/L
- Hemoglobin under 10 g/dl for Women or Under 11 g/dl for man.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Curalin as Add-On Therapy in Adults With Type 2 Diabetes Mellitus
Evaluation of Efficacy and Safety of Curalin As Add-On Therapy in Adults With Type 2 Diabetes Mellitus
Read the detailed description
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Curalin As Add-On Therapy in Adults With Type 2 Diabetes Mellitus
- Conditions
- Type2 Diabetes
- Being tested
- Curalin
- Keywords
- Diabetes, Type 2 Diabetes, placebo, Curalin, CuraLife, Momordica Charantia, Gymnema Sylvestre, Trigonella Foenum Graecum, Curcuma Longa, Emblica Officinalis, Swertia Chirata, Picrorhiza Kurroa, Syzygium Cumini/ Eugenia Jambolana, Cinnamomum Zeylanicum
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CuralinDietary supplement
Supplement capsules, 2 capsules, 3 times a day after meals. Placebo: matching placebo capsules, 2 capsules, 3 times a day after meals.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Curalin |
| Treatment | Active comparator | Not described Receives: Dietary Supplement: Curalin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of treatment with Curalin on the change in plasma HbA1c
The primary objective of this study is to evaluate the effect of treatment with Curalin on the change in plasma HbA1c.
Glycated hemoglobin (HbA1c) is a form of hemoglobin that is measured primarily to identify the three-month average plasma glucose concentration. The primary endpoint of the study is HbA1c at 1 month.
Blood for HbA1c will be taken at Screening, and M1/Termination of Study. HbA1c level will be ascertained at the local lab, according to the lab's operating procedures
Rate of patients that significantly improved their HbA1c levels at least 0.5%.
Measured: 1 month
Secondary outcomes (3)
Effect of Curalin on Fructosamin based on blood tests
To evaluate the effect of Curalin on Fructosamin level based on blood tests(mmol/L)
Measured: 1 month
Efect of Curalin on Fasting Blood Glucose Blood for glucose assessment
To evaluate the effect of Curalin on Fasting Blood Glucose Blood for glucose assessment will be taken after a 12 hour fast at Screening, Baseline, and M1/Termination of PC Study.
Fasting blood glucose level will be ascertained at the local site lab, according to the site's operating procedures.
In addition, participants will self-monitor their blood glucose levels at home once a week using a blood glucose meter.
Measured: 1 month
Safety of Curalin as assessed by adverse events
To evaluate the safety of Curalin as assessed by adverse events, including the following:
- Fasting blood chemistry including (in addition to the efficacy variables of Fructosamine): HbA1c, glucose, urea, creatinine, phosphorus, calcium, potassium, albumin, sodium (Na+) and liver function tests (ALT, AST, bilirubin and GGT), GFR, CBC.
- Vital Signs including (in addition to the efficacy variable of blood pressure): pulse rate, body temperature
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2022
- Study start3 Aug 2021
- Primary completion1 Apr 2022
- Study completion1 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type2 DiabetesStudies 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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2 arms; 1 received the investigated food supplement, and the second received a placebo.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- CuraLife
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05439473
- Sponsor's protocol ID
- Cura-02
- Status last verified
- Jun 2022
- First submitted
- 8 Jun 2021
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Curalin as Add-On Therapy in Adults With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT05439473
- Acronym / sponsor ID
- Cura-02
- Conditions
- Type2 Diabetes
- Keywords
- Diabetes, Type 2 Diabetes, placebo, Curalin, CuraLife, Momordica Charantia, Gymnema Sylvestre, Trigonella Foenum Graecum
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- CuraLifeIndustry (pharma, biotech, devices)
- Study start
- 3 Aug 2021 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 30 Jun 2022 (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.
Evaluation of Efficacy and Safety of Curalin As Add-On Therapy in Adults With Type 2 Diabetes Mellitus
Detailed description
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Curalin As Add-On Therapy in Adults With Type 2 Diabetes Mellitus
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- 2 arms; 1 received the investigated food supplement, and the second received a placebo.
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Curalin |
| Treatment | Active comparator | Dietary Supplement: Curalin |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Written informed consent is obtained.
- Adult patients (18-85 years of age) with Type II diabetes mellitus.
- HbA1c at screening is 8% - 11%.
- Body mass index (BMI)>25.
- Stable body weight (±10%) within the 3 months preceding study entry.
Key exclusion criteria (19 listed)
- Patients who have been using Curalin
- Persons with known sensitivity to any of the components of the Curalin product.
- The patient has any clinically significant uncontrolled medical condition (treated or untreated).
- Patients with renal insufficiency (glomerular filtration rate [GFR]≤30 mL/min/1.73m2).
- Pregnant or lactating women. Women of child bearing potential will be administered a urine pregnancy test at study entry. All study participants will confirm their willingness to use birth control throughout the study.
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 |
|---|---|---|
| CuralinSupplement capsules, 2 capsules, 3 times a day after meals. Placebo: matching placebo capsules, 2 capsules, 3 times a day after meals. | Dietary supplement | Placebo, Treatment |
Primary outcome
Effect of treatment with Curalin on the change in plasma HbA1c
Time frame: 1 month
The primary objective of this study is to evaluate the effect of treatment with Curalin on the change in plasma HbA1c. Glycated hemoglobin (HbA1c) is a form of hemoglobin that is measured primarily to identify the three-month average plasma glucose concentration. The primary endpoint of the study is HbA1c at 1 month. Blood for HbA1c will be taken at Screening, and M1/Termination of Study. HbA1c level will be ascertained at the local lab, according to the lab's operating procedures Rate of patients that significantly improved their HbA1c levels at least 0.5%.
3 secondary outcomes
Effect of Curalin on Fructosamin based on blood tests
Time frame: 1 month
Efect of Curalin on Fasting Blood Glucose Blood for glucose assessment
Time frame: 1 month
Safety of Curalin as assessed by adverse events
Time frame: 1 month
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 26 Oct 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Curalin in people with Type2 Diabetes, run by CuraLife at 1 site in Israel.
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 7 inclusion and 19 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 26 Oct 2026. 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 Israel. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Effect of treatment with Curalin on the change in plasma HbA1c (time frame: 1 month). 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 26 Oct 2026.