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Aloe Vera Study

Are you interested in participating in the Desert Harvest Aloe Vera Study with ICA Medical Advisory Board Member, Dr. Robert Evans? Below is the recording from the webinar that ICA hosted with Dr. Robert Evans and Desert Harvest’s Chief Executive Officer, Heather Florio on Saturday, September 12, 2020. We have also included the inclusion and exclusion criteria that is discussed during the webinar. If you meet the criteria and want to participate in the study or if you have additional questions, please call Dr. Evans office at 336-716-4131. You can also contact Desert Harvest at 1-800-222-3901.

Subject Selection

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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 treat- ment.
  • 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 Exclusionary 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 Exclusionary Criteria:

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

Deferment Criteria:

A participant will be deferred from entry into this study if he or she has any of the following conditions:

  • If a participant has active vaginitis, she will be deferred until at least four weeks from the date of symptom resolution.
  • If a participant has had any form of transvaginal surgery, hysterectomy, prolapse surgery, vaginal delivery or C-section, she will be deferred until at least 24 weeks from the date of the procedure.
  • Clinically significant laboratory abnormalities must be resolved for at least six weeks.
  • If a participant has had a positive urine culture (100,000 col.ct) during the past six weeks, he or she will be deferred until the participant has been without the condition for at least six weeks.
  • If a participant has active genital herpes or has had active genital herpes during the past 12 weeks, he or she will be deferred until the participant has been without the condition for at least 12 weeks.
  • If a participant has undergone bladder instrumentation (urethral dilation, urodynamics, bladder cystoscopy, or bladder biopsy under general or regional anesthesia) within the six weeks prior to study enrollment, he or she will be deferred until at least six weeks from the date of the procedure.
  • If a participant has undergone hydrodistension within six weeks prior to study enrollment, he or she will be deferred until at least 12 weeks from the date of the procedure.
  • If a participant has been enrolled in another investigational study or received an investigational drug or device within four weeks prior to screening.
  • If a participant has had any intravesical treatment (i.e., DMSO, heparin, cystostat, BCG) within 12 weeks prior to study enrollment, he or she will be deferred until at least 12 weeks after the last treatment received.
  • Participants treated with botulinum toxin injections for voiding dysfunction within 24 weeks prior to baseline will be deferred until 24 weeks after last treatment received.
  • Participants with a history of incontinence surgery or any other bladder or urethral surgery that could interfere with bladder function will be deferred until 24 weeks after the procedure.
  • If a male participant has had a TURP, TUIP, TUIBN, TUMT, TUNA, balloon dilation of the prostate, open prostatectomy, or any other prostate treatment such as cryotherapy or thermal therapy, he will be deferred at least 24 weeks from the date of the procedure.

Once it is formally ascertained that the condition is not present or has subsided according to the time frame identified, the participant will be reconsidered for entry into the study.

Concomitant Therapy:

  • Current therapy regimens for interstitial cystitis (i.e. antimicrobial agents, anticholinergics, antispasmodics, tricyclic antidepressants, analgesics, antihistamines, DMSO, heparin, etc.) may be continued throughout the study provided they have been at a stable dose for a minimum of 12 weeks and remain stable throughout the study. The treatment must have occurred after diagnosis of IC and administered in response to the patient’s IC symptoms.
  • The use of Elmiron (pentosan polysulfate) must be at a stable dose for a minimum of six months.
  • Medications for other medical conditions must be at a stable dose for 30 days prior to enrolling in the study.

 

 

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