Nutritional Supplementation for Bruising

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Standard Process Inc.

Must not be taking: Aluminum, Iron, PPIs, Retinol

Disqualifiers: Allergies, Liver disease, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 8 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you must not use products containing aluminum, iron, proton pump inhibitors, or topical retinol. If you are on other medications, you need to have been on a stable dose for the last 3 months before starting the trial.

Is there safety data for Vitamin C supplementation in humans?

The study on skin toxicity from radiation therapy in breast cancer patients suggests that Vitamin C, when used as part of a dietary supplement, may help reduce skin toxicity, indicating it is generally safe for human use in this context. ^{1 2 3 4 5}

How does the treatment Cyruta Plus differ from other treatments for bruising?

Cyruta Plus is unique because it is a nutritional supplement that may include a combination of vitamins and antioxidants, which can help protect against oxidative damage and support overall health. Unlike standard treatments for bruising, which may focus on topical applications or medications, Cyruta Plus potentially offers a systemic approach by enhancing the body's nutritional status. ^{6 7 8 9 10}

What data supports the effectiveness of the treatment Cyruta Plus, High Dose Vitamin C, Low Dose Vitamin C for bruising?

Research shows that Vitamin C, a component of the treatment, has been studied for its protective effects on skin health, such as reducing skin toxicity from radiation therapy in cancer patients. This suggests that Vitamin C might help improve skin conditions, which could be relevant for treating bruising. ^{1 2 11 12 13}

Are You a Good Fit for This Trial?

This trial is for healthy adults aged 55 and older who experience actinic purpura, commonly known as skin bruising due to aging. Participants should be seeing bruises on their skin but otherwise feel well.

Inclusion Criteria

Not concomitantly participating in a study involving nutritional products

I am 55 years old or older.

I have or had skin bruises due to sun damage.

Exclusion Criteria

Having a known allergy or intolerance to nuts, seeds, fruits, vegetables, oils, and fish

Not complying with the study protocol

Having a known allergy, intolerance, or dietary restriction to any of the study ingredients (Vitamin C, organic buckwheat (aerial parts) juice powder, organic buckwheat flour, bovine adrenal Cytosol™ extract, oat flour, honey, ascorbic acid, and calcium stearate)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive an 8-week nutritional supplement intervention or vitamin C supplements

8 weeks

3 visits (in-person): baseline, 4-week, and 8-week

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cyruta Plus
• High Dose Vitamin C
• Low Dose Vitamin C

Trial Overview The study tests if a nutritional supplement called Cyruta Plus can improve skin health compared to regular vitamin C. Over 8 weeks, changes in the participants' skin will be monitored through questionnaires, photos, and clinical evaluations.

How Is the Trial Designed?

Group I: Cyruta Plus Experimental Treatment 1 Intervention

Total of 27 mg daily

Group II: Low-dose Vitamin C Active Control 1 Intervention

Total of 27 mg daily

Group III: High-dose Vitamin C Active Control 1 Intervention

Total of 500 mg daily

Who Is Running the Clinical Trial?

Standard Process Inc.

Lead Sponsor

Trials

15

Recruited

680+

Published Research Related to This Trial

In a review of 13 randomized controlled trials involving 650 patients with head and neck cancer, antioxidants like vitamin E and zinc significantly reduced the severity of oral mucositis compared to placebo, with vitamin E reducing the risk of severe mucositis by 60% and zinc by 95%.

Despite these promising results, the overall quality of evidence is low due to the limited number of studies and potential biases, indicating a need for larger, more rigorous trials to confirm the effectiveness of these antioxidants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of oral and topical antioxidants in the prevention and management of oral mucositis in head and neck cancer patients: a systematic review and meta-analyses. Raza, A., Karimyan, N., Watters, A., et al.[2022]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Skin toxicity from external beam radiation therapy in breast cancer patients: protective effects of Resveratrol, Lycopene, Vitamin C and anthocianin (Ixor®). [2021]

2. Greece pubmed.ncbi.nlm.nih.gov

Tomato Juice Consumption Could Improve Breast Skin Adverse Effects of Radiotherapy in Breast Cancer Patients. [2022]

3. Germany pubmed.ncbi.nlm.nih.gov

Efficacy of oral and topical antioxidants in the prevention and management of oral mucositis in head and neck cancer patients: a systematic review and meta-analyses. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Prophylactic treatment with transdermal deferoxamine mitigates radiation-induced skin fibrosis. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

[Vitamins during high dose chemo- and radiotherapy]. [2019]

6. Switzerland pubmed.ncbi.nlm.nih.gov

A Review of the Potential Benefits of Plants Producing Berries in Skin Disorders. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Self-Adhesive and Antioxidant Poly(vinylpyrrolidone)/Alginate-Based Bilayer Films Loaded with Malva sylvestris Extracts as Potential Skin Dressings. [2022]

8. England pubmed.ncbi.nlm.nih.gov

A comparative analysis of deferoxamine treatment modalities for dermal radiation-induced fibrosis. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Protection of vitamin E, selenium, trolox C, ascorbic acid palmitate, acetylcysteine, coenzyme Q0, coenzyme Q10, beta-carotene, canthaxanthin, and (+)-catechin against oxidative damage to rat blood and tissues in vivo. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Recommended dietary allowance for vitamin C in the United States is also applicable to a population of young Japanese women. [2019]

11. Japan pubmed.ncbi.nlm.nih.gov

Nutritional status of vitamin A, E, C, B1, B2, B6, nicotinic acid, B12, folate, and beta-carotene in young women. [2019]

12. United States pubmed.ncbi.nlm.nih.gov

Controlled trial of alpha-tocopherol and beta-carotene supplements on stroke incidence and mortality in male smokers. [2019]

13. Thailand pubmed.ncbi.nlm.nih.gov

Nutrition and disease in the Japan Collaborative Cohort Study for Evaluation of Cancer (JACC). [2022]