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.
After being informed about the study and potential risks, all participants who have provided written informed consent will be screened to determine eligibility for study entry. Participants who meet the eligibility requirements will be randomized in a double-blind manner (participant and investigator) in a 4:1 ratio to aloe vera (study group) or placebo (control group), respectively. The dosing regimen will be increased by 3 capsules every month for 3 months and then reduced by 2 capsules every week during the fourth month for both groups. Participants will remain in the study for sixteen weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
30
600 mg pure, freeze-dried aloe vera super-concentrate with a minimum of 200 mg glycosaminoglycan per capsule.
550mg of Avicel microcrystalline cellulose per two-piece, hard-shelled gelatin capsule.
Wake Forest Baptist Hospital
Winston-Salem, North Carolina, United States
RECRUITINGSafety, as measured by the Change in the number and severity of adverse events (AE)
Non-serious adverse events will be defined as any new medical condition or worsening of an existing medical condition, not to include the disease being studied. Severe adverse events will be defined as any adverse event that results in death, a life-threatening event, inpatient hospitalization, prolongation of existing hospitalization (hospitalization for an elective treatment of a pre-existing condition will not be considered a serious event), disability or incapacity, or an important medical event, which, though not included previously, may jeopardize the participant and may require medical or surgical intervention.
Time frame: Week 16
Change in Interstitial cystitis (IC)/bladder pain syndrome (BPS) symptoms, as measured by the O'Leary Sant Questionnaire
The O'Leary-Sant questionnaire is composed of the Interstitial Cystitis Symptom Index (ICSI) and Problem Index (ICPI) which contains four questions related to urinary and pain symptoms. For the ICSI (score range: 0-19 points), 3 of the 4 questions utilize a range of 0-5 with 0 indicating the symptom is never experienced and 5 indicating the symptom is almost always experienced. The fourth question utilizes a range of 0-4 with 0 indicating the symptom is never experienced and 4 indicating the symptom is almost always experienced. For the ICPI (score range: 0-16 points), all four questions utilize a range of 0-4 with 0 indicating it is no problem and 4 indicating it is a big problem.
Time frame: Baseline, Weeks 4, 8, 12, and 16
Change in Suprapubic Pain, as measured by the Genitourinary Pain Index (GUPI) questionnaire
The GUPI questionnaire (score range: 0 - 45) contains nine overarching items related to urinary symptoms, pain, and impact on quality of life. Responses to items 1a, 1b, 1c, 1d, 2a, 2b, 2c, 2d, 3 and 4 are used to create a pain subscale with scores ranging from 0 -23, 0 indicating no pain and 23 indicating pain as bad as you can imagine. Responses to items 5 and 6 are used to create a urinary subscale with scores ranging from 0 -10, 0 indicating urinary symptoms are never experienced and 10 indicating they are almost always experienced. Responses to items 7, 8, and 9 are used to create a quality of life impact subscale with scores ranging from 0 -12, 0 indicating no disturbance in quality of life and 10 indicating a large disturbance in quality of life. All subscales are summed to calculate a total score.
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Time frame: Baseline, Weeks 4, 8, 12, and 16
Change in Urinary Frequency, as measured by 24-Hour Voiding Diaries
Participants will be instructed on how to complete a 24-hour voiding diary during the initial screening visit. The participant will use a new diary sheet for every 24-hour period with sections identifying time of day (with wake time and bed time indicated by participant), fluid intake (type of fluid ingested and amount in oz), urination (amount in oz voided into urinary hat or urinal), amount of urine drained via catheter if applicable, leaks (any time a participant experienced involuntary urine loss indicated by a check mark in the corresponding time column) if applicable, and pad changes (every time pad was dry indicated by a D in the corresponding time column or with a "S" "M" or "L" if the pad was wet with urine indicating a small, moderate, or large amount in the corresponding time column) if applicable.
Time frame: Baseline, Weeks 1, 2, 3, 4, 8, and 12
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
The Male and Female PROMIS Sexual Function and Satisfaction brief profile provides participants with questions related to their sexual functioning and satisfaction within the last 30 days. The male version of the questionnaire (score range: 0-50) consists of 10 items, while the female version (score range: 0-70) consists of 14 items. For both of the gender-specific versions, lower scores indicate lower interest, sexual satisfaction, and discomfort while higher scores indicate higher interest, sexual satisfaction, and discomfort.
Time frame: Baseline, Weeks 4, 8, 12, and 16
Change in Perceived Quality of Life, as measured by the McGill Quality of Life questionnaire
The McGill Quality of Life (MQOL) is a self-reported measure that contains 16-items with a single-item global scale used to measure quality of life over a 2-day timeframe. Items are scored 1-10, with 0 indicating the lowest score (not a problem) and 10 indicating the highest score (tremendous problem), for five sub-scales (physical well-being, physical symptoms, psychological, existential, and support). An overall index score can be calculated by summing the means of the five sub-scales to measure overall quality of life.
Time frame: Baseline and Week 16