Status:
UNKNOWN
Effect of Centella Asiatica on Xerotic Skin in Diabetes Mellitus Type 2
Lead Sponsor:
Indonesia University
Conditions:
Xerosis Cutis
Diabetes Mellitus, Type 2
Eligibility:
All Genders
Up to 60 years
Phase:
PHASE4
Brief Summary
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 C...
Detailed Description
This ia a double blind randomized clinical trial on patients diagnosed with DM type 2 with dry skin to assess the effect of Centella asiatica (CA) on dry skin in corellation with AGEs CML, inflammatio...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
July 30 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2019
Estimated Enrollment :
159 Patients enrolled
Trial Details
Trial ID
NCT03815305
Start Date
July 30 2018
End Date
June 30 2019
Last Update
January 24 2019
Active Locations (1)
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1
Universitas Indonesia
Jakarta Pusat, Jakarta Special Capital Region, Indonesia, 10430