Aloe Vera Capsules for Interstitial Cystitis

Overseen By Kaylee A Ferrara, BS

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Wake Forest University Health Sciences

Disqualifiers: Bladder tumors, Urethral cancer, Diabetes, others

Compensation: Varies

Number of Visits: 5

Duration: 16 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests aloe vera capsules to determine their safety and effectiveness for people with interstitial cystitis, a condition causing frequent and painful urination. Participants will take either aloe vera capsules or placebo capsules (which look the same but contain no active ingredients) over four months to compare results. It suits those who have experienced urinary frequency at least 11 times a day and discomfort for the past six months. As an Early Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if your interstitial cystitis symptoms are currently managed by your existing treatment, you may not be eligible to participate.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that super-concentrated, freeze-dried aloe vera capsules are generally safe for individuals with interstitial cystitis, a condition causing bladder pain and irritation. These capsules have been studied for their potential to reduce bladder irritation and inflammation. Although specific details about side effects from these studies aren't provided, aloe vera is typically safe for most people when taken orally. However, this study remains in its early stages. Early-phase trials often focus on safety, so researchers will closely monitor participants for any side effects. Prospective participants should discuss any concerns with the study team or a healthcare professional. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for interstitial cystitis?

Unlike standard treatments for interstitial cystitis, which often include medications like pentosan polysulfate sodium or antihistamines, the aloe vera capsules in this trial offer a natural alternative. Researchers are intrigued by aloe vera's potential anti-inflammatory properties and its ability to soothe the bladder lining. This treatment stands out because it uses a super-concentrated, freeze-dried form of aloe vera, which might enhance its effectiveness compared to more diluted forms. This unique approach could provide relief without the side effects associated with traditional pharmaceuticals.

What evidence suggests that aloe vera capsules might be an effective treatment for interstitial cystitis?

Research has shown that aloe vera capsules might help with interstitial cystitis, a condition that causes bladder pain. In earlier studies, 30% of patients felt better within two weeks, and 56% noticed improvements within a month. Notably, 87.5% of those who completed a study experienced relief from some symptoms, and 92% reported feeling better overall. In this trial, participants will receive either the experimental Desert Harvest super-concentrated, freeze-dried aloe vera capsules or placebo capsules. These findings suggest that aloe vera could reduce discomfort for many people with interstitial cystitis. ^{2 5 6 7 8}

Who Is on the Research Team?

Stephen Walker, PhD

Principal Investigator

Wake Forest Health Sciences

Are You a Good Fit for This Trial?

This trial is for adults with frequent urinary issues and pain from interstitial cystitis, who've had symptoms for at least 24 weeks. Women must use birth control if able to have children. Participants can't join if they have a history of bladder or urethral cancer, current severe diseases, allergies to aloe vera, uncontrolled diabetes, substance abuse without treatment in the past two years, are pregnant or breastfeeding, or their symptoms improve with current treatments.

Inclusion Criteria

Participant must sign and date the informed consent.

I am using or willing to use approved birth control methods if I can have children.

I can urinate more than 75cc at least once in a day.

Exclusion Criteria

I currently have a bladder or urethral stone.

Any imminent change in residence that could compromise compliance.

I have had uterine, cervical, or vaginal cancer in the last 5 years.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive super-concentrated, freeze-dried aloe vera or placebo capsules with a dosing regimen that increases monthly for 3 months and decreases weekly in the fourth month

16 weeks

4 visits (in-person) at Weeks 4, 8, 12, and 16

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Aloe Vera Capsules
• Placebo Capsules

Trial Overview The study tests the safety and effectiveness of super-concentrated freeze-dried aloe vera capsules compared to placebo capsules in managing interstitial cystitis symptoms.

How Is the Trial Designed?

Group I: Desert Harvest Super-Concentrated, Freeze-Dried Aloe Vera Capsules Experimental Treatment 1 Intervention

Participants will self-administer Desert Harvest super-concentrated, freeze-dried aloe vera capsules orally over a sixteen week period. The dosing regimen includes administering 3 capsules twice daily for the first month, 3 capsules three times daily for the second month, and 4 capsules three times daily for the third month. During the fourth month, participants will administer 10 capsules per day the first week (4 in the morning, 2 in the afternoon, and 4 in the evening), 8 capsules per day the second week (4 in the morning, 4 in the evening), 6 capsules per day the third week (3 in the morning, 3 in the evening), and 4 capsules per day the fourth week (2 in the morning, 2 in the evening). A participant must stay on a minimum of 6 capsules per day for the first three months in order to remain in the study.

Group II: Placebo Placebo Group 1 Intervention

Participants will self-administer placebo capsules orally, matching the dosing regimen of the experimental treatment, over a sixteen week period. Placebo capsules will be identical in appearance and packaging to the experimental capsules.

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

Desert Harvest

Collaborator

Trials

1

Recruited

100+

Published Research Related to This Trial

A survey of 138 women with interstitial cystitis revealed that common physical self-care strategies during acute attacks included using narcotics, antidepressants, bladder analgesics, and dietary restrictions, while psychological strategies involved distraction techniques like watching TV and seeking support from loved ones.

Less commonly used but potentially effective strategies included nonmedical interventions like massage and imagery, suggesting that increasing awareness and access to diverse self-care methods could help women manage their symptoms more effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-care strategies used for acute attack of interstitial cystitis. Webster, DC., Brennan, T.[2015]

In a study of 128 subjects with interstitial cystitis, those who experienced a 30% or greater reduction in symptoms reported significantly higher satisfaction with pentosan polysulfate sodium (PPS) therapy.

Overall, 75% of participants indicated they would recommend PPS to others with interstitial cystitis, highlighting the positive correlation between symptom improvement and treatment satisfaction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association between response to pentosan polysulfate sodium therapy for interstitial cystitis and patient questionnaire-based treatment satisfaction. Sand, PK., Kaufman, DM., Evans, RJ., et al.[2022]

Aloe vera (AV) significantly improves symptoms of irritable bowel syndrome (IBS) compared to placebo, with a standardized mean difference of 0.41 based on a meta-analysis of three randomized controlled trials involving 151 patients.

The treatment with AV showed a better response rate for IBS symptoms without any reported adverse events, indicating that it is both effective and safe for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aloe vera Is Effective and Safe in Short-term Treatment of Irritable Bowel Syndrome: A Systematic Review and Meta-analysis. Hong, SW., Chun, J., Park, S., et al.[2023]

In a study of 40 women with chronic cystitis, those who received the dietary supplement Uroprofit alongside fosfomycin showed faster improvement in symptoms and laboratory results compared to those who received fosfomycin alone.

Uroprofit demonstrated antimicrobial and anti-inflammatory effects, improved bladder microcirculation, and may help prevent future relapses of chronic cystitis, making it a valuable addition to treatment plans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The effectiveness of Uroprofit in women with chronic cystitis]. Neimark, AI., Neimark, BA., Nozdrachev, NA., et al.[2019]

In a study involving 32 rats with acetic acid-induced colitis, oral administration of aloe vera gel significantly reduced colon tissue damage and improved healing compared to untreated colitis rats.

Aloe vera gel treatment led to decreased apoptosis in colon tissues, as indicated by lower Bax mRNA expression and higher BCL-2 mRNA expression, suggesting its potential effectiveness in treating ulcerative colitis through mechanisms related to cell survival and tissue repair.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Healing Effect of Aloe Vera Gel on Acetic Acid-Induced Ulcerative Colitis in Rat. Hassanshahi, N., Masoumi, SJ., Mehrabani, D., et al.[2020]

Aloe vera whole-leaf extract was found to cause goblet cell hyperplasia and intestinal irritation in both F344/N rats and B6C3F1 mice after 13 weeks of exposure, indicating potential safety concerns.

Long-term studies revealed that Aloe vera extract is a carcinogen in the large intestine of F344/N rats, with increased incidences of tumors in higher dose groups, while no such tumors were found in mice or at lower doses in rats.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clear evidence of carcinogenic activity by a whole-leaf extract of Aloe barbadensis miller (aloe vera) in F344/N rats. Boudreau, MD., Mellick, PW., Olson, GR., et al.[2021]

Interstitial cystitis is recognized as a chronic pain syndrome rather than just a bladder disease, and its unknown causes mean that no definitive treatment exists, leading to a variety of therapeutic approaches without standardized algorithms.

Current treatments include oral medications like amitriptyline and pentosan polysulfate, intravesical therapies such as botulinum toxin A, and physical procedures like hyperbaric oxygen therapy, but many lack strong evidence of efficacy, highlighting the need for more research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The complexity of chronic pelvic pain exemplified by the condition currently called interstitial cystitis. Part 2: Treatment]. Binder, I., Rossbach, G., van Ophoven, A.[2013]

In a study of 22 patients with interstitial cystitis (IC), a quercetin-based supplement (Cysta-Q) taken for 4 weeks led to significant improvements in symptoms, with all patients reporting some level of improvement and no negative side effects observed.

The treatment resulted in substantial reductions in problem and symptom indices, as well as pain assessment scores, indicating that quercetin may be an effective and safe option for managing IC symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of interstitial cystitis with a quercetin supplement. Katske, F., Shoskes, DA., Sender, M., et al.[2013]

Interstitial cystitis is recognized as a chronic pain syndrome rather than just a disease of the bladder, highlighting the complexity of its treatment and the lack of a standard therapy.

Current treatment options include a variety of oral medications (like amitriptyline and pentosan polysulfate), intravesical therapies (such as botulinum toxin A), and physical procedures, but many lack strong evidence of efficacy, indicating a need for more research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The complexity of chronic pelvic pain exemplified by the condition currently called interstitial cystitis. Part 1: Background and basic principles]. Binder, I., van Ophoven, A.[2008]

In a study involving 82 patients with newly diagnosed interstitial cystitis, an intravesical solution containing heparin and lidocaine provided significant immediate symptom relief, with 75% of patients in the 1% lidocaine group and 94% in the 2% lidocaine group reporting improvement after one treatment.

The treatment not only offered immediate relief but also showed sustained symptom improvement, with 80% of patients receiving 2% lidocaine reporting significant relief after two weeks, indicating that the solution may help suppress nerve-related pain beyond the anesthetic effects of lidocaine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Successful downregulation of bladder sensory nerves with combination of heparin and alkalinized lidocaine in patients with interstitial cystitis. Parsons, CL.[2022]

A survey of 138 women with interstitial cystitis revealed that many self-care strategies, particularly in the body comfort category, are reported to be as effective as medications for managing symptoms like pain and urgency.

The study highlights the diverse range of over 300 self-care strategies used by patients, indicating a need for more personalized treatment approaches since there is no consensus on the best management for this chronic condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use and effectiveness of physical self-care strategies for interstitial cystitis. Webster, DC., Brennan, T.[2019]

Aloe Vera (AV) contains over 200 bioactive compounds that contribute to its health benefits, including reducing blood glucose levels, providing antioxidant effects, and promoting skin and oral health, as supported by clinical studies in humans and animals.

While AV shows promising therapeutic potential, it is important to follow recommended dosages and consult healthcare professionals due to possible risks, highlighting the need for more rigorous randomized controlled trials to confirm its efficacy and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aloe Barbadensis Miller (Aloe Vera). Kaur, S., Bains, K.[2023]

Aloe vera soft capsules (ASC) were found to be safe in toxicity tests, with no observed mortality or behavioral changes in mice at doses up to 15,000 mg/kg, indicating a high safety threshold.

In subacute toxicity tests on rats, ASC did not cause significant changes in body weight, food consumption, or any harmful effects on blood or organ health, supporting its safety for use in health products.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety evaluation of Aloe vera soft capsule in acute, subacute toxicity and genotoxicity study. Wu, J., Zhang, Y., Lv, Z., et al.[2021]

Citations

1. ichelp.org ichelp.org/wp-content/uploads/2023/05/Desert-Harvest-Survey-Analysis-1.pdf

Concentrated Oral Aloe Vera for Alleviating IC Symptoms Thirty percent of patients saw benefit within the first two weeks, and 56% of patients saw their improvement within the first month of treatment.

2. desertharvest.com desertharvest.com/pages/our-clinical-studies?srsltid=AfmBOoqzQkLW8FAuIxoeNhaQim7Abe-59mI7PUXxqP7FzMd1lM_stimZ

Our Clinical Studies | Desert Harvest SSAV Aloe Vera ... 87.5% of patients who completed the study received relief from at least some of their symptoms · 92% of patients self-reported that they 'experienced relief' ...

3. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT04734106?term=aloe&draw=2&rank=5

Safety and Efficacy of Aloe Vera in the Management ... The purpose of this study is to assess the safety and efficacy of super-concentrated, freeze-dried aloe vera capsules for treatment of interstitial cystitis.

4. urologytimes.com urologytimes.com/view/trial-to-investigate-efficacy-of-aloe-vera-in-patients-with-interstitial-cystitis

Trial to investigate efficacy of aloe vera in patients with ... We're going to do a clinical trial using Desert Harvest aloe vera and measure improvement in patients with interstitial cystitis. Florio ...

5. nutraceuticalsworld.com nutraceuticalsworld.com/exclusives/desert-harvests-aloe-ingredient-being-investigated-as-interstitial-cystitis-treatment/

FDA Approves Study on Aloe Vera as Potential Interstitial ... Desert Harvest has supported research into the potential of aloe vera in alleviating interstitial cystitis for over 30 years, noted Heather ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04734106

Safety and Efficacy of Aloe Vera in the Management ... The purpose of this study is to assess the safety and efficacy of super-concentrated, freeze-dried aloe vera capsules for treatment of interstitial cystitis.

7. ctv.veeva.com ctv.veeva.com/study/safety-and-efficacy-of-aloe-vera-in-the-management-of-the-symptoms-of-interstitial-cystitis

Safety and Efficacy of Aloe Vera in the ... - ClinicalTrials.Veeva The purpose of this study is to assess the safety and efficacy of super-concentrated, freeze-dried aloe vera capsules for treatment of ...

8. desertharvest.com desertharvest.com/collections/ssav-capsules?srsltid=AfmBOopimZVTbiU6HcshAbcjm-qiHTajDC8dmOntHqUoA6p82xdsadOf

Super-Strength Aloe Vera (SSAV) Capsules SSAV is a patented aloe vera extract clinically studied for IC/BPS, processed to remove irritants, and helps protect the bladder lining and reduce inflammation.