A Double-Blind, Placebo-Controlled Study to Establish the Safety and Efficacy of Super-Concentrated, Freeze-Dried Aloe Vera in the Management of the Symptoms of Interstitial Cystitis
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Safety, as measured by the Change in the number and severity of adverse events (AE)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Females or males, aged 18 years or older
- •Females of childbearing potential must agree to use acceptable methods of birth control. Acceptable methods are oral and injectable preparations, double barrier, vasectomized partner, or abstinence.
- •Participant must sign and date the informed consent.
- •Participant must report a urinary frequency of at least 11 times per 24-hour day, on average over the previous four weeks.
- •Participant must report a pain/discomfort score of 4 or greater on a 0-9 Likert scale.
- •These reported urinary symptoms of frequency and pain/discomfort must have been present for at least the previous 24 weeks prior to the first baseline screening visit.
- •Participants must report in the baseline voiding diary at least one voided volume greater than or equal to 75cc in a 24-hour period.
排除标准
- •Known allergy or intolerance to aloe vera in any form as reported by the participant or derived from medical records.
- •History of Bladder tumors (malignant or benign).
- •Current active bladder or urethral calculus.
- •History of urethral cancer within the previous five years.
- •Any disease which, in the opinion of the investigator, may be unstable or have bearing on the outcome of the study, including severe debilitating concurrent medical conditions such as coronary artery disease, azotemia, moderate to severe hepatic insufficiency, etc.
- •Previous treatment with Cytoxan (cyclophosphamide).
- •History of cyclophosphamide or chemical cystitis or tuberculosis or radiation cystitis.
- •History of pelvic radiation treatment, bladder cancer or cancer in situ, or urethral cancer.
- •History of any other neoplastic process currently requiring systemic, nonprophylactic treatment.
- •History of urethral diverticulum.
- •Inability to void spontaneously.
- •Subjects with interstitial cystitis symptoms alleviated by current therapy regimen.
- •Uncontrolled diabetes mellitus.
- •Previous enrollment in an aloe vera study.
- •Previous use of Desert Harvest super-concentrated, freeze-dried aloe vera capsules.
- •Any imminent change in residence that could compromise compliance.
- •Unlikely to be compliant due to unmanaged medical or psychological problem, including dementia, aphasia, or other deficits of cognition or speech/language function that will interfere with the participant's ability to complete the study.
- •Substance abuse or dependency problem within the past two years for which patient received no treatment.
- •Male-Specific Exclusion Criteria:
- •Males with a history of prostate cancer within the previous five years.
- •Males with a prostatic infection within the previous three months.
- •Female-Specific Exclusion Criteria:
- •Females with a history of uterine, cervical, or vaginal cancer within the previous five years.
- •Pregnant or lactating females.
研究组 & 干预措施
Desert Harvest Super-Concentrated, Freeze-Dried Aloe Vera Capsules
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.
干预措施: Desert Harvest Aloe Vera Capsules (Drug)
Placebo
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.
干预措施: Placebo Capsules (Other)
结局指标
主要结局
Safety, as measured by the Change in the number and severity of adverse events (AE)
时间窗: Week 16
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.
次要结局
- Change in Urinary Frequency, as measured by 24-Hour Voiding Diaries(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(Baseline, Weeks 4, 8, 12, and 16)
- Change in Suprapubic Pain, as measured by the Genitourinary Pain Index (GUPI) questionnaire(Baseline, Weeks 4, 8, 12, and 16)
- Change in Interstitial cystitis (IC)/bladder pain syndrome (BPS) symptoms, as measured by the O'Leary Sant Questionnaire(Baseline, Weeks 4, 8, 12, and 16)
- Change in Perceived Quality of Life, as measured by the McGill Quality of Life questionnaire(Baseline and Week 16)