Contact information
Type
Scientific
Primary contact
Prof Sun Changhao
ORCID ID
Contact details
157 Baojian Road
Nangang District
Harbin
150081
China
+86 (0)451 87502801
sun2002changhao@yahoo.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
003
Study information
Scientific title
Supplementation with curcumin versus placebo treatment to lower blood glucose in diabetics: a randomised controlled trial
Acronym
CD
Study hypothesis
The function of curcumin in lowering blood glucose in diabetic patients.
Ethics approval
Medical Ethics Committee of Public Health College, Harbin Medical University, approved on the 25th June 2009 (ref: 003)
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Diabetes mellitus
Intervention
We determine glucose and insulin with related blood indicators in a hospital. The drug name is Curcumin Qingtang tablet. The dosage given is 2.0 g/60 kg BW/d, equivalent Curcumin 300 mg/kg, take this drug orally for a month.
Intervention type
Drug
Phase
Not Applicable
Drug names
Curcumin
Primary outcome measures
Amended as of 21/09/2010:
1. Lipids (triglycerides [TG], total cholestrol [TC], low-density liporotein cholesterol [LDL-C], high-density lipoprotein cholesterol [HDL-C])
2. Free fatty acids (FFAs)
3. Lipoprotein lipase (LPL)
4. Adipocyte fatty acid-binding protein (AFABP)
5. Liver ultrasonography
6. HbA1c
7. Apolipoproteins (ApoA1/ApoB)
8. Triacylglycerol
9. Cholesterol
10. 2-hour post-prandial glucose
11. Homeostasis model assessment - insulin resistance (HOMA-IR)
Initial information at time of registration:
1. Glucose
2. Insulin
Secondary outcome measures
Amended as of 21/09/2010:
1. Age
2. Body mass index (BMI)
3. Diabetes duration
4. Cigarette use
5. Physical activity level
6. Food Frequency Questionnaire (FFQ)
Initial information at time of registration:
1. Red blood cell
2. White blood cell
3. Haemoglobin
4. Total protein
5. Albumin
6. Urea nitrogen
7. Creatinine
8. Alanine transaminase
9. Aspartate transaminase
10. Platelet count
11. Height
12. Weight
13. Waist circumference
14. Hip circumference
15. Blood pressure
Overall trial start date
01/05/2009
Overall trial end date
30/07/2009
Reason abandoned
Eligibility
Participant inclusion criteria
1. Type 2 diabetes mellitus; the condition of patients are stable
2. Fasting blood glucose greater than or equal to 7.8 mmol/L or postprandial blood glucose greater than or equal to 11.1 mmol/L
3. Aged 18 - 65 years, both male and female
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
100
Participant exclusion criteria
1. Type I diabetes
2. Pregnant or lactating women, or allergic to the tested samples
3. Have history of liver, kidney, hypertension, mental illness, taking other hypoglycaemics
4. People are uncooperative
5. Have diabetic ketosis, acidosis and infection in recent 3 months
6. Taking correlated medications which could potentially influence the purpose of this study
7. Failing to take drugs or the information is incomplete
Recruitment start date
01/05/2009
Recruitment end date
30/07/2009
Locations
Countries of recruitment
China
Trial participating centre
157 Baojian Road
Harbin
150081
China
Sponsor information
Organisation
Public Health College - Harbin Medical University (China)
Sponsor details
c/o Changhao Sun
157 Baojian Road
Nangang District
Harbin
150081
China
+86 (0)451 87502801
sun2002changhao@yahoo.com
Sponsor type
University/education
Website
Funders
Funder type
Research organisation
Funder name
Amended as of 21/09/2010:
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
National Natural Science Foundation of China (NSFC) (China) and Canadian Institutes of Health Research (CIHR) (Canada) - China-Canada Joint Health Research Initiative (ref: 30810107)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Initial information at time of registration:
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Development of Health Foods (China)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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