A Phase 3 interventional study of di indolylmethane (DIM) and Red rice bran in Cervical Dysplasia, sponsored by New York Presbyterian Hospital. Completed at 1 site in United States. Open to female participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-03-29.
Sponsored by New York Presbyterian Hospital · Phase 3, Interventional, and Treatment
To determine if the use of oral Diindolylmethante (DIM), a marketed cruciferous vegetable based dietary supplement (Bioresponse-DIM), is associated with the regression of cervical dysplasia in otherwise healthy women.
To determine if the use of oral Diindolylmethane (DIM), a marketed cruciferous vegetable based dietary supplement (BioResponse-DIM®), is associated with the regression of cervical dysplasia in otherwise healthy women. Additionally, the study aims to see how the use of the BioResponse-DIM supplement correlates with cervical HPV colonization, and to asses the tolerability of daily DIM supplementation
356 studies on the registry are indexed under Uterine Cervical Dysplasia; 68 are open to participants now.
This study's planned enrollment of 62 is below the median of 166 across 249 interventional studies indexed under Uterine Cervical Dysplasia.
Browse Uterine Cervical Dysplasia studies →New York Presbyterian Hospital is the lead sponsor of 20 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
2mg/kg/day po of DIM
Drug: di indolylmethane (DIM)
this agent is not generally thought to be active but may be
Dietary Supplement: Red rice bran
This is the agent being studies. Similar agents have been reported to have potential activity.
this will act as the active comparator. The sponsor provided this as the "placebo" arm since it is a filler component of their DIM capsules
Measure the regression of CIN in women by cytology, colposcopy, and biopsy,
To determine if oral DIM is effective in promoting the regression of CIN in women
Time frame: 3 months
HPV colonization by commercial ELIZA test
To correlate the response to DIM with HPV colonization
Time frame: 3 months
Adverse events reported by subjects and lab abnormalities i.e. CBC and SMA20
To assess for any adverse effects of oral DIM in women
Time frame: one year
This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.
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New York Presbyterian Hospital