Diabetes Mellitus, Type 2 Clinical Trial
Official title:
Effect of Centella Asiatica on Xerotic Skin in Diabetes Mellitus Type 2: a Study on N(6)-Carboxymethyl-lysine, Interleukin 1-α, Dan Superoxide Dismutase in Stratum Corneum
Verified date | January 2019 |
Source | Indonesia University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The objective of this study is to evaluate the effect of Centella asiatica on hydration status of lower leg skin of DM type 2 patients by measuring SRRC and Skin Capacitance in correlation with AGEs CML, inflammation marker IL-1α, and oxidative stress SOD in stratum corneum.
Status | Active, not recruiting |
Enrollment | 159 |
Est. completion date | June 30, 2019 |
Est. primary completion date | January 12, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 60 Years |
Eligibility |
Inclusion Criteria: - Diagnosed with Diabetes Mellitus Type 2 - <60 years old by the end of the study - suffered from dry skin on lower leg skin area, (minimum score= 3, measured using SRRC) - agree to not use any skin care product orally or topically on lower leg skin and any other drugs (unless its part of diabetes mellitus management) - normal ankle brachial index value ranged from 0.91-1.3 Exclusion Criteria: - the presence of diabetic ulcer on one of patient's foot - the presence of infection or dermatitis on the experimented foot - the presence of severe inflammation on the experimented skin (redness score >2 or/and fissure score >2 measured by SRRC or/and total SRRC score ranged from12-16) - estimated glomerular filtration rate value (eGFR) < 45 - impaired liver function (increased by 2x from upper limit reference for AST/ALT) |
Country | Name | City | State |
---|---|---|---|
Indonesia | Universitas Indonesia | Jakarta Pusat | Jakarta |
Lead Sponsor | Collaborator |
---|---|
Indonesia University |
Indonesia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Skin Capacitance | SCap measured in (AU) | 1 month (evaluated every 2 weeks) | |
Primary | Change in SOD | Superoxide Dismutase (compared to total protein) | 1 month (evaluated every 2 weeks) | |
Primary | Change in IL-1a | Interleukin-1a (compared to total protein) | 1 month (evaluated every 2 weeks) | |
Primary | Change in AGEs CML | Advanced Glycation End Product, N-(Carboxymethyl)lysine (compared to total protein) | 1 month (evaluated every 2 week) | |
Primary | Change in SRRC | Specified symptom sum score. Measuring dry skin using four variables (scale, roughness, redness, and cracking) in score ranged from 1 to 4 for each variable. The highest the value marks the driest skin | 1 month (evaluated every 2 week) |
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