UnknownPhase 4

Effect of Centella Asiatica on Xerotic Skin in Diabetes Mellitus Type 2

Indonesia159 participantsStarted 2018-07-30

Plain-language 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.

Who can participate

Age range

60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Skin Capacitance

Timeframe: 1 month (evaluated every 2 weeks)

Change in SOD

Timeframe: 1 month (evaluated every 2 weeks)

Change in IL-1α

Timeframe: 1 month (evaluated every 2 weeks)

Change in AGEs CML

Timeframe: 1 month (evaluated every 2 week)

Change in SRRC

Timeframe: 1 month (evaluated every 2 week)

Trial details

NCT IDNCT03815305

SponsorIndonesia University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-01-12

View on ClinicalTrials.gov More Xerosis Cutis trials

Who can participate

Age range

60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in Skin Capacitance

Timeframe: 1 month (evaluated every 2 weeks)

Change in SOD

Timeframe: 1 month (evaluated every 2 weeks)

Change in IL-1α

Timeframe: 1 month (evaluated every 2 weeks)

Change in AGEs CML

Timeframe: 1 month (evaluated every 2 week)

Change in SRRC

Timeframe: 1 month (evaluated every 2 week)