Status:
TERMINATED
CuraLin Herbal Supplement for Type 2 Diabetes
Lead Sponsor:
National University of Natural Medicine
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
18-75 years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 8 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 14 2022
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT05267925
Start Date
January 8 2022
End Date
April 14 2022
Last Update
April 5 2023
Active Locations (2)
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1
National University of Natural Medicine
Portland, Oregon, United States, 97201
2
Institute of Complementary Medicine
Seattle, Washington, United States, 98122