Trial Outcomes & Findings for Efficacy and Safety of Hizikia Fusiformis Extract in Subjects Showing Erosive Gastritis (NCT NCT01689701)

Results Overview

Erosions was measured in study visit 1(0 week) and visit 3(4 week). Gastric erosion occurs when the mucous membrane lining the stomach becomes inflamed.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

54 participants

Primary outcome timeframe

4 weeks

Results posted on

2019-09-20

Participant Flow

The study subjects were recruited from Clinical Trial Center for Functional Food in Chonbuk National University Hospital during the 2011. Only those subjects who were Subjects Showing Erosive Gastritis and were not diagnosed with any disease were included in this study.

Among the 79 subjets screened, 25 subjects had endoscopy and/or laboratory tests results that were in the exclusion criteria category, hence they were excluded from the study.

Participant milestones

Participant milestones
Measure	Hizikia Fusiformis Extract Hizikia Fusiformis extract(1.3g/d) for 12weeks Hizikia Fusiformis extract: Hizikia Fusiformis by Ethanol and extracted with concentrated	Placebo Placebo(1.3g/day) for 4weeks Placebo : Amount and calorie of placebo are same with Hizikia Fusiformis extract.
Overall Study STARTED	27	27
Overall Study COMPLETED	22	21
Overall Study NOT COMPLETED	5	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy and Safety of Hizikia Fusiformis Extract in Subjects Showing Erosive Gastritis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Hizikia Fusiformis Extract n=27 Participants Hizikia Fusiformis extract(1.3g/d) for 12weeks Hizikia Fusiformis extract: Hizikia Fusiformis by Ethanol and extracted with concentrated	Placebo n=27 Participants Placebo(1.3g/day) for 4weeks Placebo : Amount and calorie of placebo are same with Hizikia Fusiformis extract.	Total n=54 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	27 Participants n=5 Participants	27 Participants n=7 Participants	54 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	39.1 years STANDARD_DEVIATION 11.9 • n=5 Participants	38.7 years STANDARD_DEVIATION 10.0 • n=7 Participants	38.9 years STANDARD_DEVIATION 10.9 • n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	22 Participants n=7 Participants	40 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	5 Participants n=7 Participants	14 Participants n=5 Participants
Region of Enrollment Korea, Republic of	27 participants n=5 Participants	27 participants n=7 Participants	54 participants n=5 Participants

PRIMARY outcome

Timeframe: 4 weeks

Erosions was measured in study visit 1(0 week) and visit 3(4 week). Gastric erosion occurs when the mucous membrane lining the stomach becomes inflamed.

Outcome measures

Outcome measures
Measure	Hizikia Fusiformis Extract n=22 Participants Hizikia Fusiformis extract(1.3g/d) for 12weeks Hizikia Fusiformis extract: Hizikia Fusiformis by Ethanol and extracted with concentrated	Placebo n=21 Participants Placebo(1.3g/day) for 4weeks Placebo : Amount and calorie of placebo are same with Hizikia Fusiformis extract.
Changes in Erosions Pre	4.36 erosions Standard Deviation 2.48	3.38 erosions Standard Deviation 2.89
Changes in Erosions Post	2.32 erosions Standard Deviation 2.10	2.43 erosions Standard Deviation 3.28

PRIMARY outcome

Timeframe: 4 weeks

Score of erosions(score 1-4) was measured in study visit 1(0 week) and visit 3(4 week). Score of erosions is assigned a score of between 1 (Erosion = 0) to 4 (Erosion ≥ 6) and summed to form a score ranging from 1 (best) to 4 (worst).

Outcome measures

Outcome measures
Measure	Hizikia Fusiformis Extract n=22 Participants Hizikia Fusiformis extract(1.3g/d) for 12weeks Hizikia Fusiformis extract: Hizikia Fusiformis by Ethanol and extracted with concentrated	Placebo n=21 Participants Placebo(1.3g/day) for 4weeks Placebo : Amount and calorie of placebo are same with Hizikia Fusiformis extract.
Changes in Score of Erosions Pre	3.00 Scores on a scale Standard Deviation 0.76	2.71 Scores on a scale Standard Deviation 0.78
Changes in Score of Erosions Post	2.23 Scores on a scale Standard Deviation 0.92	2.05 Scores on a scale Standard Deviation 1.12

SECONDARY outcome

Timeframe: 4 weeks

Subjects' symptoms total score(score 0-24) was measured in study visit 1(0 week) and visit 3(4 week). The original index consists of 8 Questions. Individual question response is assigned a score of between 0 (none) to 3 (moderate) and summed to form a score ranging from 0 (best) to 24 (worst).

Outcome measures

Outcome measures
Measure	Hizikia Fusiformis Extract n=22 Participants Hizikia Fusiformis extract(1.3g/d) for 12weeks Hizikia Fusiformis extract: Hizikia Fusiformis by Ethanol and extracted with concentrated	Placebo n=21 Participants Placebo(1.3g/day) for 4weeks Placebo : Amount and calorie of placebo are same with Hizikia Fusiformis extract.
Changes in Subjects' Symptoms Total Score Pre	2.77 Units on a scale Standard Deviation 2.56	3.90 Units on a scale Standard Deviation 4.15
Changes in Subjects' Symptoms Total Score Post	2.77 Units on a scale Standard Deviation 3.18	2.57 Units on a scale Standard Deviation 3.37

SECONDARY outcome

Timeframe: 4 weeks

Gastrin was measured in study visit 1(0 week) and visit 3(4 week).

Outcome measures

Outcome measures
Measure	Hizikia Fusiformis Extract n=22 Participants Hizikia Fusiformis extract(1.3g/d) for 12weeks Hizikia Fusiformis extract: Hizikia Fusiformis by Ethanol and extracted with concentrated	Placebo n=21 Participants Placebo(1.3g/day) for 4weeks Placebo : Amount and calorie of placebo are same with Hizikia Fusiformis extract.
Changes in Gastrin Pre	37.36 pg/ml Standard Deviation 16.43	36.44 pg/ml Standard Deviation 16.88
Changes in Gastrin Post	32.05 pg/ml Standard Deviation 15.27	27.61 pg/ml Standard Deviation 10.86

SECONDARY outcome

Timeframe: 4 weeks

PepsinogenⅠ was measured in study visit 1(0 week) and visit 3(4 week).

Outcome measures

Outcome measures
Measure	Hizikia Fusiformis Extract n=22 Participants Hizikia Fusiformis extract(1.3g/d) for 12weeks Hizikia Fusiformis extract: Hizikia Fusiformis by Ethanol and extracted with concentrated	Placebo n=21 Participants Placebo(1.3g/day) for 4weeks Placebo : Amount and calorie of placebo are same with Hizikia Fusiformis extract.
Changes in PepsinogenⅠ Pre	50.15 ng/mL Standard Deviation 14.78	54.72 ng/mL Standard Deviation 16.24
Changes in PepsinogenⅠ Post	55.28 ng/mL Standard Deviation 19.08	57.96 ng/mL Standard Deviation 19.42

SECONDARY outcome

Timeframe: 4 weeks

PepsinogenⅡ was measured in study visit 1(0 week) and visit 3(4 week).

Outcome measures

Outcome measures
Measure	Hizikia Fusiformis Extract n=22 Participants Hizikia Fusiformis extract(1.3g/d) for 12weeks Hizikia Fusiformis extract: Hizikia Fusiformis by Ethanol and extracted with concentrated	Placebo n=21 Participants Placebo(1.3g/day) for 4weeks Placebo : Amount and calorie of placebo are same with Hizikia Fusiformis extract.
Changes in PepsinogenⅡ Pre	13.40 ng/ml Standard Deviation 8.38	12.65 ng/ml Standard Deviation 7.46
Changes in PepsinogenⅡ Post	15.39 ng/ml Standard Deviation 10.16	13.66 ng/ml Standard Deviation 8.09

SECONDARY outcome

Timeframe: 4 weeks

Pepsinogen Ⅰ/Ⅱ ratio was measured in study visit 1(0 week) and visit 3(4 week).

Outcome measures

Outcome measures
Measure	Hizikia Fusiformis Extract n=22 Participants Hizikia Fusiformis extract(1.3g/d) for 12weeks Hizikia Fusiformis extract: Hizikia Fusiformis by Ethanol and extracted with concentrated	Placebo n=21 Participants Placebo(1.3g/day) for 4weeks Placebo : Amount and calorie of placebo are same with Hizikia Fusiformis extract.
Changes in Pepsinogen Ⅰ/Ⅱ Ratio Pre	4.66 ratio Standard Deviation 1.86	5.17 ratio Standard Deviation 1.83
Changes in Pepsinogen Ⅰ/Ⅱ Ratio Post	4.56 ratio Standard Deviation 1.84	5.07 ratio Standard Deviation 1.73

SECONDARY outcome

Timeframe: 4 weeks

Hs-CRP(High Sensitivity C-reactive Protein) was measured in study visit 1(0 week) and visit 3(4 week).

Outcome measures

Outcome measures
Measure	Hizikia Fusiformis Extract n=22 Participants Hizikia Fusiformis extract(1.3g/d) for 12weeks Hizikia Fusiformis extract: Hizikia Fusiformis by Ethanol and extracted with concentrated	Placebo n=21 Participants Placebo(1.3g/day) for 4weeks Placebo : Amount and calorie of placebo are same with Hizikia Fusiformis extract.
Changes in Hs-CRP(High Sensitivity C-reactive Protein) Pre	0.63 mg/L Standard Deviation 1.24	0.16 mg/L Standard Deviation 0.19
Changes in Hs-CRP(High Sensitivity C-reactive Protein) Post	0.23 mg/L Standard Deviation 0.4	0.75 mg/L Standard Deviation 2.01

Adverse Events

Hizikia Fusiformis Extract

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

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. Sang-Wook Kim, MD

Clinical Trial Center for Functional Foods; Chonbuk National University Hospital

Phone: 82-63-276-8284

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place