NCT03815305

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
159

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jul 2018

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 30, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 12, 2019

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

January 18, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 24, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
Last Updated

January 24, 2019

Status Verified

January 1, 2019

Enrollment Period

6 months

First QC Date

January 18, 2019

Last Update Submit

January 20, 2019

Conditions

Xerosis CutisDiabetes Mellitus, Type 2

Keywords

dry skindm type 2centella asiaticasuperoxide dismutaseAGEs CMLIL-1α

Outcome Measures

Primary Outcomes (5)

  • Change in Skin Capacitance

    SCap measured in (AU)

    1 month (evaluated every 2 weeks)

  • Change in SOD

    Superoxide Dismutase (compared to total protein)

    1 month (evaluated every 2 weeks)

  • Change in IL-1α

    Interleukin-1α (compared to total protein)

    1 month (evaluated every 2 weeks)

  • Change in AGEs CML

    Advanced Glycation End Product, N-(Carboxymethyl)lysine (compared to total protein)

    1 month (evaluated every 2 week)

  • Change in SRRC

    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

    1 month (evaluated every 2 week)

Study Arms (3)

Topical CA and Placebo Oral Drug

ACTIVE COMPARATOR

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

Drug: Topical CA

Petroleum Jelly and placebo oral drug

PLACEBO COMPARATOR

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

Drug: Petroleum jelly

Centella asiatica extract and Topical CA

EXPERIMENTAL

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

Drug: Centella Asiatica Extract

Interventions

Centella Asiatica ExtractDRUG

centlla asiatica oral drug at 1100 mg dose

Also known as: Oral CA
Centella asiatica extract and Topical CA
Topical CADRUG

1% centella asiatica ointment

Also known as: Centella asiatica ointment
Topical CA and Placebo Oral Drug
Petroleum jellyDRUG

vaseline album

Also known as: Topical Placebo
Petroleum Jelly and placebo oral drug

Eligibility Criteria

AgeUp to 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitas Indonesia

Jakarta Pusat, Jakarta Special Capital Region, 10430, Indonesia

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Centella asiatica extractPetrolatum

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

HydrocarbonsOrganic Chemicals

Study Officials

  • Suhendro Suhendro, Doctor

    Indonesia University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

January 18, 2019

First Posted

January 24, 2019

Study Start

July 30, 2018

Primary Completion

January 12, 2019

Study Completion

June 30, 2019

Last Updated

January 24, 2019

Record last verified: 2019-01

Locations

ID(1)