Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-26 @ 2:12 AM
Study NCT ID:
NCT03815305
Status:
UNKNOWN
Last Update Posted:
2019-01-24
First Post:
2019-01-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Centella Asiatica on Xerotic Skin in Diabetes Mellitus Type 2
Sponsor:
Indonesia University
Organization:
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2019-01
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: