Clinical trial NCT05267925: CuraLin Herbal Supplement for Type 2 Diabetes
Official title: Single-arm, Open Label Clinical Trial of CuraLin in Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Type 2 Diabetes
Lead sponsor: National University of Natural Medicine
Sponsor class: OTHER
First posted: 2022-03-07
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Hemoglobin A1C
timeFrame: 12 Weeks
measure: Gamma-glutamyltransferase (GGT)
timeFrame: 12 Weeks
measure: Aspartate aminotransferase (AST)
timeFrame: 12 Weeks
measure: Alanine aminotransferase (ALT)
timeFrame: 12 Weeks
measure: Homeostatic Model Assessment of Insulin Resistance
timeFrame: 12 Weeks
Secondary outcomes:
measure: Fasting Blood Glucose
timeFrame: 12 Weeks
measure: Estimated glomerular filtration rate
timeFrame: 12 Weeks
measure: Triglycerides
timeFrame: 12 Weeks
measure: LDL:HDL ratio
timeFrame: 12 Weeks
measure: BMI
timeFrame: 12 Weeks
measure: Creatinine
timeFrame: 12 weeks
measure: Blood urea nitrogen (BUN)
timeFrame: 12 weeks
Other outcomes:
measure: PROMIS-29 Health-related Quality of Life
timeFrame: 12 Weeks
Locations:
city: Portland
country: United States
facility: National University of Natural Medicine
state: Oregon
city: Seattle
country: United States
facility: Institute of Complementary Medicine
state: Washington
Study officials:
References: