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ISRCTN
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ISRCTN83308122
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DOI
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10.1186/ISRCTN83308122
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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Effects of Hintonia latiflora in type 2 diabetics
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Scientific title
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Six-month clinical trial to investigate the effect of Hintonia latiflora in the dietetic treatment of mild and moderate type II diabetes mellitus
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Acronym
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N/A
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Serial number at source
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Gehrlicher 01/2007
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Study hypothesis
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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
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Lay summary
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Lay summary under review 1
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Ethics approval
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Not provided at time of registration
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Study design
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Open prospective dietary intervention study with a duration of six months
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Countries of recruitment
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Slovakia
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Disease/condition/study domain
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Mild and moderate Diabetes mellitus of type II (age-related)
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Participants - inclusion criteria
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1. Type 2 diabetics
2. Between the ages of 45 and 80 f
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).
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Participants - exclusion criteria
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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.
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Anticipated start date
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01/01/2008
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Anticipated end date
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31/12/2011
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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30-40
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Interventions
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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.
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Primary outcome measure(s)
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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.
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Secondary outcome measure(s)
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1. Safety laboratory including liver function tests
2. Physical symptoms
3. Adverse events
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Sources of funding
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Gehrlicher Extrakte (Germany)
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Trial website
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Publications
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Contact name
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Dr
Marta
Korecova
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Address
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Head of Diabetes Department
IDF President
Rc: 425201/734
Vel’komoravská 2
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City/town
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Trencin
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Zip/Postcode
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91101
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Country
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Slovakia
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Email
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Korecova.dea@stonline.sk
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Sponsor
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Gehrlicher Pharmazeutische Extrakte GmbH (Germany)
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Address
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Robert-Koch-Str. 5
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City/town
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Eurasburg
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Zip/Postcode
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82547
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Country
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Germany
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Tel
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+49 8179 99779 0
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Fax
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+49 8179 99779 69
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Email
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production@gehrlicher.de
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Sponsor website:
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http://www.gehrlicher.de
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Date applied
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31/08/2012
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Last edited
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07/09/2012
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Date ISRCTN assigned
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07/09/2012
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