CuraLin Herbal Supplement for Type 2 Diabetes

NCT ID: NCT05267925

Last Updated: 2023-04-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-08
• Study Completion Date: 2022-04-14

Brief Summary

The purpose of this study is to provide preliminary data necessary for a larger, controlled trial of CuraLin as a treatment option for T2DM. This study will also fill the gap in literature surrounding herbal medicine in the treatment of T2DM. The use of herbal preparations for diabetes has increased globally, and given the costs, adverse effects, lack of clinical outcome improvement, and minimal A1c reductions associated with medications, safer, more affordable alternatives need to be explored. CuraLin™ is a dietary supplement manufactured by NutraStar Inc. and sold by CuraLife; it is a blend of nine ayurvedic plants and herbs taken three times daily, after meals for the management of diabetes. It is hypothesized that CuraLin will be safely tolerated among adults with Type 2 Diabetes Mellitus, and will improve glucose control and cardiometabolic risk factors over this 12 week study.

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention

All participants will be asked to take the dietary herbal supplement CuraLin for the duration of the study. All participants will take 2 capsules orally, three times per day following meals for 12 weeks.

Group Type: EXPERIMENTAL

CuraLin

Intervention Type: DIETARY_SUPPLEMENT

CuraLin™ is a dietary supplement manufactured by NutraStar Inc. and sold by CuraLife; it is a blend of nine ayurvedic plants and herbs.

The CuraLin formulation contains the following ingredients (per 2 capsules):

• Mormordica charantia (fruit) - 300mg
• Gymnema sylvestre (leaf) - 80mg
• Trigonella foenum-Graecum (seed) - 100mg
• Curcuma longa (rhizome) - 100mg
• Phyllanthus embilica officinalis (fruit) - 100mg
• Swertia chiraytia (leaf) - 80mg
• Syzgium Cumini (seed) - 100mg
• Neopicrorhiza Picrorhiza/Scrophulariiflora Kurroa (root) - 100mg
• Cinnamoum verum/zeylanicum - 40 mg
• Hydroxypropyl methylcellulose
• Rice Flour

Interventions

CuraLin

CuraLin™ is a dietary supplement manufactured by NutraStar Inc. and sold by CuraLife; it is a blend of nine ayurvedic plants and herbs.

The CuraLin formulation contains the following ingredients (per 2 capsules):

• Mormordica charantia (fruit) - 300mg
• Gymnema sylvestre (leaf) - 80mg
• Trigonella foenum-Graecum (seed) - 100mg
• Curcuma longa (rhizome) - 100mg
• Phyllanthus embilica officinalis (fruit) - 100mg
• Swertia chiraytia (leaf) - 80mg
• Syzgium Cumini (seed) - 100mg
• Neopicrorhiza Picrorhiza/Scrophulariiflora Kurroa (root) - 100mg
• Cinnamoum verum/zeylanicum - 40 mg
• Hydroxypropyl methylcellulose
• Rice Flour

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Community-dwelling adults ≥18 and ≤ 75 years of age.
• Have an existing diagnosis of type 2 diabetes without known complications; i.e. eye damage (retinopathy), nerve damage (diabetic peripheral neuropathy), kidney damage (diabetic kidney disease), or heart damage (recent myocardial infarction or severe congestive heart failure).
• Must be on a stable dose (i.e. consistent dose for three months or greater) of all medications.
• Must be on a stable dose of dietary supplements for one month prior to enrollment.
• Have a serum hemoglobin A1c between 7% and 9.5%.
• Able to communicate via email, fill out a computer-administered questionnaire, and to read and write in English.
• Willing to have blood drawn at 3 separate time points.
• Willing to take an herbal supplement three times a day, daily, for 12 weeks.
• Willing to abstain from new anti-diabetic therapies, vitamins, minerals, dietary supplements, and lipid-lowering agents for 12 weeks.
• Willing and able to follow the study protocol and attend study visits.
• Approved to be eligible for study participation at the discretion of the Principal Investigators, after review of the Formal Eligibility Screen results.

Exclusion Criteria

• Allergy to any ingredient found in the study product (Mormordica charantia (fruit), Gymnema sylvestre (leaf), Trigonella foenum-Graecum (seed), Curcuma longa (rhizome), Phyllanthus embilica officinalis (fruit), Swertia chiraytia (leaf), Syzgium Cumini (seed), Neopicrorhiza Picrorhiza/Scrophulariiflora Kurroa (root), Cinnamoum verum/zeylanicum, Hydroxypropyl methylcellulose, Rice Flour).
• Current use of insulin.
• Current use of CuraLin or any dietary supplement that has the same ingredients as CuraLin (see list of ingredients above).
• Current use of the following lipid-lowering medications: Ezetimibe (Zetia), Cholestyramine (Prevalite, Questran, Questran Light), Colesevelam (Welchol), or Colestipol (Colestid, Colestid Flavored).
• History of myocardial infarction or stroke within the last 6 months, current coronary artery disease, unstable angina, uncontrolled hypertension (i.e. systolic > 180 or diastolic > 110), congestive heart failure, or stated history of coronary bypass surgery or heart stent placement.
• Current active diabetic ulcers or history of diabetic neuropathy.
• Active malignancy, with the exception of basal cell carcinoma, squamous cell carcinoma, and/or carcinoma in situ of the cervix.
• Current diagnosis of Small Intestinal Bacterial Overgrowth (SIBO), Small Intestinal Fungal Overgrowth (SIFO), Inflammatory Bowel Disease (IBD; i.e. Crohn's or Ulcerative Colitis), or other diagnosed pathology of the gastrointestinal tract (excluding Irritable Bowel Syndrome, [IBS]).
• Presence of an unstable and/or significant medical disorder that would compromise the participant's safety to take part in the study.
• Planned elective surgery within the next 12 weeks.
• Pregnant, nursing, or planning a pregnancy within the next 12 weeks.
• Women of childbearing age not using standard birth control measures.
• History of liver and/or kidney disease.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National University of Natural Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

National University of Natural Medicine

Portland, Oregon, United States

Institute of Complementary Medicine

Seattle, Washington, United States

Countries

United States

Other Identifiers

RBKK8321

Identifier Type: -

Identifier Source: org_study_id