Clinical trial NCT03815305: Effect of Centella Asiatica on Xerotic Skin in Diabetes Mellitus Type 2
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Xerosis Cutis
Diabetes Mellitus, Type 2
Keywords: dry skin
dm type 2
centella asiatica
superoxide dismutase
AGEs CML
IL-1α
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2019-01-24
Enrollment: 159
Sex: ALL
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 CML, inflammation marker IL-1α, and oxidative stress SOD in stratum corneum.

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, inflammation marker IL-1α, and oxidative stress SOD in stratum corneum after four weeks of treatment. Subjects are divided into three groups of treatment. The first group treated with oral CA and topical CA, second group treated with oral placebo and topical CA, and the last group treated with oral and topical placebo. The total subjects in each treatment groups are 53 subjects. The recruited subjects will be randomized to receive three different treatments, consist of 1. First group (A) will receive combination of oral CA at 2x1100 mg dose and 1% topical CA ointment. 2. Second group (B) will receive oral placebo and topical CA 1% ointment 3. Third group (C) will receive oral placebo and petroleum jelly as topical placebo The recruited subjects will still receive the prescribed treatment for DM type 2. The treatment for dry skin will be administered for 28 days. Randomization done by our supervisor using computer program (RandlistR) by assigning code number for each subjects. The procedures of treatment administration are explained below: 1. Every subject will receive 56 capsules and 10 gram of ointment to be used in 2 weeks period. Subjects will also receive explanation on how to take the drugs 2. Oral drug are taken 2 capsules (@ 550 mg) b.i.d over 12 hours. 3. The ointment is applied two times a day 15 minutes after bath time. 4. The application have to be distributed evenly on a specific 7 x 20 cms area on lower leg. All patients will be given plastic cover to determine the area. 5. The estimation of ointment applied on every leg is as much as ½ FTU or about 0,25 gram. 6. After 2 week period ended, subject will be given the same treatment at follow-up visit.

Eligibility criteria: 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)

Primary outcomes:
measure: Change in Skin Capacitance
timeFrame: 1 month (evaluated every 2 weeks)
measure: Change in SOD
timeFrame: 1 month (evaluated every 2 weeks)
measure: Change in IL-1α
timeFrame: 1 month (evaluated every 2 weeks)
measure: Change in AGEs CML
timeFrame: 1 month (evaluated every 2 week)
measure: Change in SRRC
timeFrame: 1 month (evaluated every 2 week)
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Universitas Indonesia
state: Jakarta
Study officials:
affiliation: Indonesia University
name: Suhendro Suhendro, Doctor
role: STUDY_CHAIR
References: