A study of supplementation with Curcumin to Diabetics

ISRCTN	ISRCTN49723587
DOI	https://doi.org/10.1186/ISRCTN49723587
Protocol serial number	003
Sponsor	Public Health College - Harbin Medical University (China)
Funders	Amended as of 21/09/2010:, National Natural Science Foundation of China (NSFC) (China) and Canadian Institutes of Health Research (CIHR) (Canada) - China-Canada Joint Health Research Initiative (ref: 30810107), Initial information at time of registration:, Development of Health Foods (China)

Submission date: 27/04/2010
Registration date: 14/06/2010
Last edited: 21/09/2010

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Sun Changhao
Scientific

157 Baojian Road
Nangang District
Harbin
150081
China

Phone	+86 (0)451 87502801
Email	sun2002changhao@yahoo.com

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Supplementation with curcumin versus placebo treatment to lower blood glucose in diabetics: a randomised controlled trial
Study acronym	CD
Study objectives	The function of curcumin in lowering blood glucose in diabetic patients.
Ethics approval(s)	Medical Ethics Committee of Public Health College, Harbin Medical University, approved on the 25th June 2009 (ref: 003)
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Curcumin
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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
Completion date	30/07/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	100
Key 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
Key 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
Date of first enrolment	01/05/2009
Date of final enrolment	30/07/2009

Locations

Countries of recruitment

China

Study participating centre

157 Baojian Road

Harbin
150081
China

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes