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Evaluation of Efficacy and Safety of Curalin As Add-On Therapy in Adults With Type 2 Diabetes Mellitus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05631431
Recruitment Status : Recruiting
First Posted : November 30, 2022
Last Update Posted : November 30, 2022
Sponsor:
Information provided by (Responsible Party):
CuraLife

Brief Summary:
Evaluation of Efficacy and Safety of Curalin As Add-On Therapy in Adults with Type 2 Diabetes Mellitus

Condition or disease Intervention/treatment Phase
Type2 Diabetes Dietary Supplement: Curalin Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double-blind for 3 months, after 3 months - open-label
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Supportive Care
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
Actual Study Start Date : October 15, 2021
Estimated Primary Completion Date : May 15, 2023
Estimated Study Completion Date : June 30, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo Dietary Supplement: Curalin
Curalin capsules, 2 capsules, 3 times a day after meals Placebo: matching placebo capsules, 2 capsules, 3 times a day after meals

Active Comparator: Treatment Dietary Supplement: Curalin
Curalin capsules, 2 capsules, 3 times a day after meals Placebo: matching placebo capsules, 2 capsules, 3 times a day after meals




Primary Outcome Measures :
  1. primary objective [ Time Frame: 3-6 months ]
    The primary objective of this study is to evaluate the effect of treatment with Curalin on the change in plasma HbA1c.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Diagnosis and Criteria for Inclusion:

Patients may be included in the study if they meet all of the following criteria:

  • Written informed consent is obtained.
  • Adult patients (18-85 years of age) with Type II diabetes mellitus
  • HbA1c at screening is 7.5% - 10%
  • 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.

Criteria for Exclusion: Patients will be excluded from participating in this study if they meet 1 or more of the following criteria:

  • Patients who have been using Curalin At least once in the past 3 months
  • 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 childbearing 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.
  • 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

  • The 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 under 130 mEq/L
  • Hemoglobin under 10 g/dl for Women or Under 11 g/dl for man

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05631431


Contacts
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Contact: Ofer Yigdal, Msc/ CPO +972522582179 Ofer@curalife.com
Contact: Liron Hason, Bsc/ CRA +972543838100 Liron@curalife.com

Locations
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Israel
Soroka Medical Center Recruiting
Be'er Sheva, Israel
Contact: Bar Bourenbloum, B.sc    54-2529452 ext +972    barborn@clalit.org.il   
Principal Investigator: Idit Liberty, MD         
Lin Medical Center Recruiting
Haifa, Israel
Contact: Elinor Man, B.sc    54-8380118 ext +972    ElinorMa23@clalit.org.il   
Principal Investigator: Michal Gershinsky, MD         
Herzelia Diebetes Center Recruiting
Herzliya, Israel
Contact: Lilach Dolgikh, B.sc    52-5292240 ext +972    Lilachdo1@clalit.org.il   
Principal Investigator: Eitan Roitman, MD         
Ichilov Medical Center Recruiting
Tel Aviv, Israel
Contact: Asaf Buch, Phd    54-9931033 ext +972    asafbu@tlvmc.gov.il   
Principal Investigator: Roy Eldor, MD         
Sponsors and Collaborators
CuraLife
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Responsible Party: CuraLife
ClinicalTrials.gov Identifier: NCT05631431    
Other Study ID Numbers: Cura-01
First Posted: November 30, 2022    Key Record Dates
Last Update Posted: November 30, 2022
Last Verified: November 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by CuraLife:
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
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases