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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Topical CA and Placebo Oral Drug | Active Comparator | Patient given 10gr 1% CA ointment and 56 pcs of placebo drug |
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| Petroleum Jelly and placebo oral drug | Placebo Comparator | Patient given 10gr petroleum jelly 100% topical ointment and 56 pcs of placebo drug |
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| Centella asiatica extract and Topical CA | Experimental | Patient given 10gr 1% CA ointment and 56 pcs of drug containing CA |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Centella Asiatica Extract | Drug | centlla asiatica oral drug at 1100 mg dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Suhendro Suhendro, Doctor | Indonesia University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitas Indonesia | Jakarta Pusat | Jakarta Special Capital Region | 10430 | Indonesia |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C526146 | Centella asiatica extract |
| D010577 | Petrolatum |
| ID | Term |
|---|---|
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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| Topical CA | Drug | 1% centella asiatica ointment |
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| Petroleum jelly | Drug | vaseline album |
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| D004700 | Endocrine System Diseases |