Condition category
Nutritional, Metabolic, Endocrine
Date applied
27/04/2010
Date assigned
14/06/2010
Last edited
21/09/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://yxzy.hrbmu.edu.cn/gongwei/english/home.asp?id=400

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

Publication citations

Additional files

Editorial Notes