What side effects are associated with this type of intervention?

Common treatments for Interstitial Cystitis (IC) include Pentosan polysulfate sodium (PPS), which can cause gastrointestinal disturbances and retinal abnormalities; Amitriptyline, which may lead to drowsiness, dry mouth, and weight gain; and antihistamines, which often result in drowsiness and dry mouth. NSAIDs like ibuprofen can cause gastrointestinal issues and potential kidney damage with long-term use. Physical therapy for pelvic floor muscle tenderness generally has minimal side effects but may cause temporary discomfort.

What prior FDA approvals exist?

The FDA has approved several treatments for Interstitial Cystitis, focusing on alleviating symptoms and inflammation. Pentosan polysulfate sodium (Elmiron) is the only oral medication specifically approved for IC, which helps to restore the bladder lining and reduce irritation. Other treatments include intravesical therapies such as dimethyl sulfoxide (DMSO), which has anti-inflammatory and analgesic properties. While Aloe Vera capsules are being studied for their anti-inflammatory and soothing effects, they are not yet FDA-approved for IC treatment.

What other types of research exist?

Promising novel alternatives to Aloe Vera capsules for Interstitial Cystitis patients include: 1) Intravesical instillation of Dimethyl Sulfoxide (DMSO), which has anti-inflammatory and analgesic properties. 2) Oral Pentosan Polysulfate Sodium (Elmiron), which helps to restore the bladder lining. 3) Myofascial physical therapy, which targets pelvic floor dysfunction. 4) Acupuncture, which has shown benefits in managing chronic pelvic pain. These alternatives have demonstrated efficacy in clinical studies and may offer relief for IC patients.

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Herbal Supplement

Aloe Vera Capsules for Interstitial Cystitis

Q: What is the mechanism of action of this treatment?

Common treatments for Interstitial Cystitis (IC) often focus on reducing inflammation and soothing the bladder lining to alleviate pain and discomfort. Anti-inflammatory agents, such as nonsteroidal anti-inflammatory drugs (NSAIDs), help reduce inflammation and pain. Physical therapy aims to release myofascial trigger points and reduce pelvic floor muscle spasm, which can alleviate pain and improve bladder function. Cognitive behavioral programs address psychological symptoms, improving overall quality of life. Aloe Vera Capsules, with their anti-inflammatory and soothing effects, may help reduce bladder inflammation and promote healing, offering symptom relief for IC patients. These treatments are crucial as they target the underlying inflammation and pain, providing much-needed relief and improving the quality of life for those suffering from IC.

Phase < 1

Waitlist Available

Led By Stephen Walker, PhD

Research Sponsored by Wake Forest University Health Sciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants must report in the baseline voiding diary at least one voided volume greater than or equal to 75cc in a 24-hour period.

Participant must report a urinary frequency of at least 11 times per 24-hour day, on average over the previous four weeks.

Must not have

Current active bladder or urethral calculus.

Females with a history of uterine, cervical, or vaginal cancer within the previous five years.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, weeks 1, 2, 3, 4, 8, and 12

Summary

This trial is testing whether strong, dried aloe vera capsules can help people with interstitial cystitis, a painful bladder condition. Aloe vera is known for its soothing effects and might reduce inflammation and pain. Participants will take increasing doses of the capsules over several months to see if their symptoms improve.

Who is the study for?

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.

What is being tested?

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

What are the potential side effects?

While not specified here, potential side effects may include digestive discomfort such as cramps or diarrhea due to aloe vera's laxative properties; allergic reactions could occur in those sensitive to aloe.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I go to the bathroom to urinate at least 11 times a day.

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My pain or discomfort level is 4 or higher on a scale of 0 to 9.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I currently have a bladder or urethral stone.

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

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I cannot urinate on my own.

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I am not currently on treatment for any cancer other than the one being studied.

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I have been treated with Cytoxan before.

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I have had radiation in my pelvic area or had bladder, urethral, or in situ cancer.

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I have used Desert Harvest aloe vera capsules before.

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My diabetes is not well-managed.

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I have a history of bladder issues due to medication, chemicals, TB, or radiation.

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I am a male who had prostate cancer in the last 5 years.

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I have had bladder tumors before, whether cancerous or not.

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I have had a urethral diverticulum.

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I am a male who had a prostate infection in the last 3 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, weeks 1, 2, 3, 4, 8, and 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, weeks 1, 2, 3, 4, 8, and 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, weeks 1, 2, 3, 4, 8, and 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Safety, as measured by the Change in the number and severity of adverse events (AE)

Secondary study objectives

Change in Interstitial cystitis (IC)/bladder pain syndrome (BPS) symptoms, as measured by the O'Leary Sant Questionnaire

Change in Perceived Quality of Life, as measured by the McGill Quality of Life questionnaire

Change in Sexual Functioning and Satisfaction, as measured by the Male and Female Patient-Reported Outcomes Measurement Information System (PROMIS) Sexual Function and Satisfaction Brief Profile

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Desert Harvest Super-Concentrated, Freeze-Dried Aloe Vera CapsulesExperimental Treatment1 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: PlaceboPlacebo Group1 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.

0 / 16Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Interstitial Cystitis (IC) often focus on reducing inflammation and soothing the bladder lining to alleviate pain and discomfort. Anti-inflammatory agents, such as nonsteroidal anti-inflammatory drugs (NSAIDs), help reduce inflammation and pain. Physical therapy aims to release myofascial trigger points and reduce pelvic floor muscle spasm, which can alleviate pain and improve bladder function. Cognitive behavioral programs address psychological symptoms, improving overall quality of life. Aloe Vera Capsules, with their anti-inflammatory and soothing effects, may help reduce bladder inflammation and promote healing, offering symptom relief for IC patients. These treatments are crucial as they target the underlying inflammation and pain, providing much-needed relief and improving the quality of life for those suffering from IC.

Effects of hyperbaric oxygen therapy on hydrochloric acid-induced interstitial cystitis in rats: a histological and ultrastructural study.P2X and P2X receptor expression in human bladder urothelium and changes in interstitial cystitis.Lack of effect following repeated in vivo exposure of the rabbit urinary bladder to urine from interstitial cystitis patients at low infusion volumes.