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

Sponsor

Indonesia University (Other)

Overall Status

Unknown status

CT.gov ID

NCT03815305

Collaborator

(none)

159

Enrollment

Location

Arms

Anticipated Duration (Months)

14.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Xerosis Cutis Diabetes Mellitus, Type 2	Drug: Centella Asiatica Extract Drug: Topical CA Drug: Petroleum jelly	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

159 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jul 30, 2018

Actual Primary Completion Date :

Jan 12, 2019

Anticipated Study Completion Date :

Jun 30, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Topical CA and Placebo Oral Drug Patient given 10gr 1% CA ointment and 56 pcs of placebo drug	Drug: Topical CA 1% centella asiatica ointment Other Names: Centella asiatica ointment
Placebo Comparator: Petroleum Jelly and placebo oral drug Patient given 10gr petroleum jelly 100% topical ointment and 56 pcs of placebo drug	Drug: Petroleum jelly vaseline album Other Names: Topical Placebo
Experimental: Centella asiatica extract and Topical CA Patient given 10gr 1% CA ointment and 56 pcs of drug containing CA	Drug: Centella Asiatica Extract centlla asiatica oral drug at 1100 mg dose Other Names: Oral CA

Arm

Intervention/Treatment

Active Comparator: Topical CA and Placebo Oral Drug

Patient given 10gr 1% CA ointment and 56 pcs of placebo drug

Drug: Topical CA

1% centella asiatica ointment

Other Names:

Centella asiatica ointment

Placebo Comparator: Petroleum Jelly and placebo oral drug

Patient given 10gr petroleum jelly 100% topical ointment and 56 pcs of placebo drug

Drug: Petroleum jelly

vaseline album

Other Names:

Topical Placebo

Experimental: Centella asiatica extract and Topical CA

Patient given 10gr 1% CA ointment and 56 pcs of drug containing CA

Drug: Centella Asiatica Extract

centlla asiatica oral drug at 1100 mg dose

Other Names:

Oral CA

Outcome Measures

Primary Outcome Measures

Change in Skin Capacitance [1 month (evaluated every 2 weeks)]
SCap measured in (AU)
Change in SOD [1 month (evaluated every 2 weeks)]
Superoxide Dismutase (compared to total protein)
Change in IL-1α [1 month (evaluated every 2 weeks)]
Interleukin-1α (compared to total protein)
Change in AGEs CML [1 month (evaluated every 2 week)]
Advanced Glycation End Product, N-(Carboxymethyl)lysine (compared to total protein)
Change in SRRC [1 month (evaluated every 2 week)]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)