Trial Outcomes & Findings for Rhubarb and Angiotensin Converting Enzyme Inhibitor (NCT NCT00672451)

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

8 participants

Primary outcome timeframe

up to 15 months

Results posted on

2018-12-13

Participant Flow

5 Participants were not included in the study analysis or assigned to a group prior to termination.

Participant milestones

Participant milestones
Measure	Rhubarb Extract will receive rhubarb extract rhubarb extract: titrate rhubarb extract titrated up to 6grams daily by mouth	Placebo receive placebo placebo: placebo titrated up to 6 pills daily as patient tolerates
Overall Study STARTED	1	2
Overall Study COMPLETED	1	2
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Rhubarb and Angiotensin Converting Enzyme Inhibitor

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Rhubarb Extract n=1 Participants will receive rhubarb extract rhubarb extract: titrate rhubarb extract titrated up to 6grams daily by mouth	Placebo n=2 Participants receive placebo placebo: placebo titrated up to 6 pills daily as patient tolerates	Total n=3 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: up to 15 months

Population: Data not collected in all participants of the placebo group.

Outcome measures

Outcome measures
Measure	Rhubarb Extract n=1 Participants will receive rhubarb extract rhubarb extract: titrate rhubarb extract titrated up to 6grams daily by mouth	Placebo n=1 Participants receive placebo placebo: placebo titrated up to 6 pills daily as patient tolerates
Albumin Concentration in Urine	.3 mg/dL Standard Deviation 0	7.9 mg/dL Standard Deviation 0

SECONDARY outcome

Timeframe: 2 years

Population: No data collected

Outcome measures

Outcome data not reported

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Rhubarb Extract

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. John Burkart

Wake Forest University Health Sciences

Phone: 33671662958

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place