Condition category
Nutritional, Metabolic, Endocrine
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
We were carrying out a study to measure the effect of a dietary supplement containing an extract from the bark of the South American tree Hintonia latiflora on blood sugar control. The aim of the study was to see if preparations of this plant extract are useful in the treatment of local cases of diabetes.

Who can participate?
Adults suffering from age-related diabetes.

What does the study involve?
Participants will take one capsule before meals twice daily while adhering to the prescribed diet. Only routine examinations will be carried out during the study, such as measurement of blood sugar values and HbA1c as a parameter for long-term development of diabetes.

What are the possible benefits and risks of participating?
A delay of the requirement of treating diabetics with insulin is a clinical target in diabetes therapy, and increases the quality of life of patients. No adverse reactions have been observed in previous examinations and experience with exposure to Hintonia bark preparations. Participating patients are screened for potential adverse events.

Where is the study run from?
A medical diabetes center.

When is the study starting and how long is it expected to run for?
The study started in 2009 and was stopped in 2011.

Who is funding the study?
Gehrlicher Pharmazeutische Extrakte in Eurasburg/Obb., Germany.

Who is the main contact?
Dr Marta Korecova

Trial website

Contact information



Primary contact

Dr Marta Korecova


Contact details

Head of Diabetes Department
IDF President
Rc: 425201/734
Vel’komoravská 2

Additional identifiers

EudraCT number number

Protocol/serial number

Gehrlicher 01/2007

Study information

Scientific title

Six-month clinical trial to investigate the effect of Hintonia latiflora in the dietetic treatment of mild and moderate type 2 diabetes mellitus


Study hypothesis

Intake of capsules with an extract of the bark of the South American plant Hintonia latiflora as a
dietary measure contributes to controlling and improving parameters of diabetes mellitus.

Ethics approval

Not provided at time of registration

Study design

Open prospective dietary intervention study with a duration of 6 months

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Mild and moderate diabetes mellitus of type II (age-related)


Sucontral® D Capsules, Harras Pharma Curarina, Munich, with 100 mg of a dry concentrate per capsule (extraction solvent ethanol 32°%) from the bark of the Central American plant Hintonia latiflora (SESSÉ & MOC. ex DC.) BULLOCK (Rubiaceae). The plant material came from controlled collection. Per capsule, 24 mg polyphenols are supplied. The capsules also contained 30 mg vitamin C, 5 mg vitamin E, 0.7 mg vitamin B1, 0.8 mg vitamin B2, 1 mg vitamin B6, 0.5 µg vitamin B12, 100 µg folic acid, 75 µg biotin, 2.5 mg zinc and 25 µg chromium. 1 capsule before meals twice daily while adhering to the prescribed diet.

Intervention type



Not Applicable

Drug names

Primary outcome measures

Fasting blood sugar and postprandial blood sugar (two hours after food intake) as well as blood pressure and body weight were recorded at monthly intervals. The HbA1c value was recorded after three and six months as were the liver values and blood lipids.

Secondary outcome measures

1. Safety laboratory including liver function tests
2. Physical symptoms
3. Adverse events

Overall trial start date


Overall trial end date


Reason abandoned


Participant inclusion criteria

1. Type 2 diabetics
2. Between the ages of 45 and 80
3. Neither oral antidiabetic agents nor insulin were used
4. Prescribed diet had led to stable but not nearly normoglycaemic values

As a condition for inclusion in the study, diabetic symptoms must have existed for a period of at least 12 months. The values for fasting blood sugar had to be in the range from 7-14 mmol/l (normal value: 3.9-5.4 mmol/l).

Participant type


Age group




Target number of participants


Participant exclusion criteria

To be excluded were patients for whom there was a doubt about the reliability with respect to the adherence to the dietetic guidelines (e.g., with regard to alcohol consumption). Other exclusion reasons were severe diabetic symptoms, progressive life-threatening diseases, hepatic dysfunction or renal insufficiency (deviations of GOT, γGT and AP of more than twice the normal value, serum creatinine > 130 µmol/l), hypoglycaemic crises not noticed in time, retinopathy, pregnancy, malignant tumours and/or drug or alcohol dependence in the medical history.

Recruitment start date


Recruitment end date



Countries of recruitment


Trial participating centre

Head of Diabetes Department

Sponsor information


Gehrlicher Pharmazeutische Extrakte GmbH (Germany)

Sponsor details

Robert-Koch-Str. 5
+49 8179 99779 0

Sponsor type




Funder type


Funder name

Gehrlicher Extrakte (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2014 results in:

Publication citations

  1. Results

    Korecova M, Hladikova M, Treatment of mild and moderate type-2 diabetes: open prospective trial with Hintonia latiflora extract., Eur. J. Med. Res., 2014, 19, 16, doi: 10.1186/2047-783X-19-16.

Additional files

Editorial Notes