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Change in sponsor priority.
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Purpura is a macule or papule of blood in the skin. It is mostly seen in mature skin that is often prone to significant bruising. Small lesions of less than 5 mm are called petechiae and larger ones, found mostly in subcutaneous tissue, are called ecchymosis. Actinic purpura occurs almost exclusively in elderly populations. This single-blind randomized clinical trial evaluates the effect of an 8-week nutritional supplement intervention in comparison with isolated vitamin C supplements on actinic purpura in older adults. We will enroll thirty (30) otherwise healthy participants, both male and female, aged 55 years and older. Changes in participants' skin condition will be assessed at visit 1 (baseline), visit 2 (4-week), and visit 3 (8-week) using questionnaires, standard digital photography, and clinical grading of the skin lesions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cyruta Plus | Experimental | Total of 27 mg daily |
|
| Low-dose Vitamin C | Active Comparator | Total of 27 mg daily |
|
| High-dose Vitamin C | Active Comparator | Total of 500 mg daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cyruta Plus: A Whole-Food Based Vitamin C supplement containing organic buckwheat (aerial parts) juice powder, organic buckwheat flour, bovine adrenal Cytosolâ„¢ extract, oat flour, honey, ascorbic acid | Dietary Supplement | 27 mg vitamin C, organic buckwheat (aerial parts) juice powder, organic buckwheat flour, bovine adrenal Cytosolâ„¢ extract, oat flour, honey, ascorbic acid, and calcium stearate |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Endpoint | The number of participants who report a reduction in the number of purpura lesions as evaluated through dermatological examination before and after supplementation. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Endpoint | Average decrease in actinic purpura lesion measurements in millimeters across participants. | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Standard Process - Nutrition Innovation Center | Kannapolis | North Carolina | 28081 | United States |
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|
| Low Dose Vitamin C | Dietary Supplement | 27 mg ascorbic acid |
|
| High Dose Vitamin C | Dietary Supplement | 500 mg ascorbic acid |
|
| ID | Term |
|---|---|
| D004438 | Ecchymosis |
| ID | Term |
|---|---|
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D006722 | Honey |
| D001205 | Ascorbic Acid |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
| D013400 | Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D006880 | Hydroxy Acids |
| D002241 | Carbohydrates |
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