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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02529969
Other study ID # 615
Secondary ID
Status Recruiting
Phase Phase 2/Phase 3
First received August 19, 2015
Last updated August 19, 2015
Start date July 2015

Study information

Verified date July 2015
Source National Nutrition and Food Technology Institute
Contact Golbon Sohrab
Phone +98-21-22077424
Email golbonsohrab@yahoo.com
Is FDA regulated No
Health authority IRAN: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

Diabetes mellitus is the most common endocrine disorder, causes many complications such as micro- and macro-vascular diseases. Various kinds of antidiabetic drugs have been developed, but most of them have side effects. Recently, the use of natural plant products has gained more attention among scientists in order to prevent diabetic vascular complications. Curcumin is a natural yellow product derived from the turmeric rhizome which has shown to be non-toxic and exhibits various bio¬logical activities such as anti-oxidant, anti-inflammatory, anti-carcinogenic, and anti-diabetic effects. Curcumin is effective in reducing glycemic index and hyperlipidemia in rodent models and is relatively inexpensive and safe. Most of the studies conducted on animal model, and just a few of them are on human model. The present study was planned to evaluate the effects of curcumin supplementation on serum levels of lipid profile and inflammatory markers in patients with type 2 diabetes


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date
Est. primary completion date January 2016
Accepts healthy volunteers No
Gender Both
Age group 40 Years to 65 Years
Eligibility Inclusion Criteria:

1. Tendency to participate

2. Age range of 40-65

3. Suffering from diabetes type 2 ( between 1 to 10 yeares)

4. BMI 18/5-30

5. Patients with diabetes who administer oral hypoglycemic agents and do not use

Exclusion Criteria:

1. patients with liver diseases

2. patients with kidney diseases

3. patients with inflammatory diseases

4. patients with liver diseases

5. Administering herbal agents

6. Administering multivitamins and minerals in past 3 months

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Intervention

Dietary Supplement:
curcumin

Placebo


Locations

Country Name City State
Iran, Islamic Republic of NNFTRI clinic Tehran

Sponsors (1)

Lead Sponsor Collaborator
National Nutrition and Food Technology Institute

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Triglyceride 12 weeks No
Secondary C-Reactive Protein 12 weeks No
See also
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Recruiting NCT03073343 - A Prospective, Randomized, Open Label Trial of Two Doses of Oral Betaine N/A
Completed NCT02529982 - Curcumin Supplementation and Patients With Type 2 Diabetes N/A
Recruiting NCT01745900 - Evaluation and Comparison of Noninvasive Blood Glucose Concentrations N/A
Completed NCT00835861 - Effectiveness of Metformin Compared to Insulin in Pregnant Women With Mild Preexisting or Early Gestational Diabetes Phase 2