| Trial ID: | L6886 |
| Source ID: | NCT03815305
|
| Associated Drug: |
Centella Asiatica Extract
|
| Title: |
Effect of Centella Asiatica on Xerotic Skin in Diabetes Mellitus Type 2
|
| Acronym: |
|
| Status: |
UNKNOWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Xerosis Cutis|Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: Centella Asiatica Extract|DRUG: Topical CA|DRUG: Petroleum jelly
|
| Outcome Measures: |
Primary: Change in Skin Capacitance, SCap measured in (AU), 1 month (evaluated every 2 weeks)|Change in SOD, Superoxide Dismutase (compared to total protein), 1 month (evaluated every 2 weeks)|Change in IL-1α, Interleukin-1α (compared to total protein), 1 month (evaluated every 2 weeks)|Change in AGEs CML, Advanced Glycation End Product, N-(Carboxymethyl)lysine (compared to total protein), 1 month (evaluated every 2 week)|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) |
|
| Sponsor/Collaborators: |
Sponsor: Indonesia University
|
| Gender: |
ALL
|
| Age: |
CHILD, ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
159
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2018-07-30
|
| Completion Date: |
2019-06-30
|
| Results First Posted: |
|
| Last Update Posted: |
2019-01-24
|
| Locations: |
Universitas Indonesia, Jakarta Pusat, Jakarta, 10430, Indonesia
|
| URL: |
https://clinicaltrials.gov/show/NCT03815305
|
