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

NCT ID: NCT03815305

Last Updated: 2019-01-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 159 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-30
• Study Completion Date: 2019-06-30

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.

Conditions

Xerosis Cutis; Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Topical CA and Placebo Oral Drug

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

Group Type: ACTIVE_COMPARATOR

Topical CA

Intervention Type: DRUG

1% centella asiatica ointment

Petroleum Jelly and placebo oral drug

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

Group Type: PLACEBO_COMPARATOR

Petroleum jelly

Intervention Type: DRUG

vaseline album

Centella asiatica extract and Topical CA

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

Group Type: EXPERIMENTAL

Centella Asiatica Extract

Intervention Type: DRUG

centlla asiatica oral drug at 1100 mg dose

Interventions

Centella Asiatica Extract

centlla asiatica oral drug at 1100 mg dose

Intervention Type: DRUG

Topical CA

1% centella asiatica ointment

Intervention Type: DRUG

Petroleum jelly

vaseline album

Intervention Type: DRUG

Other Intervention Names

Oral CA; Centella asiatica ointment; Topical Placebo

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)

• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Indonesia University

OTHER

Sponsor Role: lead

Responsible Party

Dr. Lili Legiawati, SpKK(K)

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Suhendro Suhendro, Doctor

Role: STUDY_CHAIR

Indonesia University

Locations

Universitas Indonesia

Jakarta Pusat, Jakarta Special Capital Region, Indonesia

Countries

Indonesia

Other Identifiers

441/UN2.F1/ETIK/2018/

Identifier Type: -

Identifier Source: org_study_id