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Status unknownNCT04233658Updated Jan 22, 2020

Cynara Scolymus Extract for Treatment of Diabetes Mellitus Type 2

A Phase 3 interventional study of Placebo and Cynara Scolymus in Diabetes Mellitus, Type 2, sponsored by Stefan Fischli. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-01-22.

Sponsored by Stefan Fischli · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Edible parts of the artichoke plant (Cynara cardunculus, Cynara scolymus) are traditionally known in folk-medicine for lipid lowering and choleretic effects. Furthermore, antidiabetic effects are described. In the past year's research attributed health promoting effects to the main active compounds chlorogenic acid, luteolin and apigenin. Present literature indicates potential antidiabetic effects by different mechanisms like downregulation of gluconeogenesis, increased GLP-1 secretion and modification of insulin signalling. Up to now only few human clinical trials provide insufficient data to conclude the therapeutic potential of cynara scolymus extract in the treatment of type 2 diabetes.

The primary objective is to evaluate the antidiabetic effect and the mechanisms of glucose lowering by a 12-week treatment with a highly-standardized extract of cynara scolymus in subjects with diabetes mellitus type 2 compared to placebo.

02

Conditions studied

  • Diabetes Mellitus, Type 2
03

In context

Diabetes Mellitus

10,926 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's planned enrollment of 20 is below the median of 80 across 8,368 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

This is the only study on the registry with Stefan Fischli as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Male or female ≥18 years old.
  • Diagnosis of diabetes mellitus type 2 ≥ 90 days prior to screening
  • HbA1c-level between 6.5-9%
  • Body mass index of ≥ 28 kg/m2
  • Stable daily dose (for at least 30 days) of 1-3 oral antidiabetic drug (metformin, sulfonylurea, SGLT-2 inhibitor, thiazolidinedione or DPP-IV-inhibitor)

Exclusion criteria

Exclusion Criteria:

  • Subjects with diabetes mellitus type 1 or history of ketoacidosis,
  • Uncontrolled diabetes, defined as fasting plasma glucose ≥20mmol/l or recurrent hypoglycemia (defined as capillary glucose values ≤3.5mmol/l)
  • Use of insulin or GLP-1-receptor agonists
  • Women wanting to become pregnant
  • Pregnant or breast-feeding women
  • Known hepatic disorder
  • Severe renal insufficiency (GFR ≤30ml/min)
  • History of inflammatory bowel disease
  • History of gastric bypass or gastric sleeve surgery
  • Anticoagulation with vitamin K-antagonists
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
20 participants (estimated)

Study arms

  • Placebo comparator
    Placebo

    Drug: Placebo

  • Experimental
    Cynara Scolymus

    Drug: Cynara Scolymus

Interventions

  • DrugPlacebo

    3x2 capsules / day

  • DrugCynara Scolymus

    3x2 capsules / day

06

What researchers measure

Primary outcomes

  1. Change of HbA1c-level from baseline to week 12

    Time frame: 12 weeks

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 22, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04233658
Lead sponsor
Stefan Fischli
Responsible party
Stefan Fischli (Deputy Head Division of Endocrinology and Diabetes, Luzerner Kantonsspital) — Sponsor-investigator
First posted
Jan 18, 2020
Start date
May 2020 (estimated)
Primary completion
May 2022 (estimated)
Completion
Dec 2022 (estimated)
Last update
Jan 22, 2020

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.

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