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Trial Outcomes & Findings for Efficacy of Omija (Schisandra Chinensis) Extract in Subjects With Knee Osteoarthritis (NCT NCT01472822)

NCT ID: NCT01472822

Last Updated: 2013-02-04

Results Overview

WOMAC(Western Ontario and McMaster University Osteoarthritis Index) total score (score 0-96) was measured in study visit 1(0 week) and visit 3(12 week). The original index consists of 24 Questions. Individual question response is assigned a score of between 0 (none) to 4 (extreme) and summed to form a score ranging from 0 (best) to 96 (worst).

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

60 participants

Primary outcome timeframe

12 weeks

Results posted on

2013-02-04

Participant Flow

Participants were recruited through local advertising and doctor referrals from hospital outpatients and general practice clinics.

The criteria were an age from 30 to 70 years, mild to Moderate KO as indicated by WOMAC(Western Ontario and McMaster Universities Arthritis Index) score ≥ 38 subjects.

Participant milestones

Participant milestones
Measure
Omija Extract.
Omija extract.(2times/day, 4tablets/day, 1.2g/day) for 12weeks Omija extract.: Omija extracted with ethanol and then concentrated and dried.
Placebo
Placebo(2times/day, 4tablets/day, 1.2g/day) for 12weeks Placebo : Amount and calorie of placebo are same with Omija extract..
Overall Study
STARTED
30
30
Overall Study
COMPLETED
28
28
Overall Study
NOT COMPLETED
2
2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy of Omija (Schisandra Chinensis) Extract in Subjects With Knee Osteoarthritis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Omija
n=30 Participants
Placebo
n=30 Participants
Total
n=60 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
30 Participants
n=5 Participants
30 Participants
n=7 Participants
60 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
52.1 years
STANDARD_DEVIATION 9.5 • n=5 Participants
52.4 years
STANDARD_DEVIATION 9.6 • n=7 Participants
52.2 years
STANDARD_DEVIATION 9.5 • n=5 Participants
Sex: Female, Male
Female
27 Participants
n=5 Participants
28 Participants
n=7 Participants
55 Participants
n=5 Participants
Sex: Female, Male
Male
3 Participants
n=5 Participants
2 Participants
n=7 Participants
5 Participants
n=5 Participants
Region of Enrollment
Korea, Republic of
30 participants
n=5 Participants
30 participants
n=7 Participants
60 participants
n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: per protocol analysis

WOMAC(Western Ontario and McMaster University Osteoarthritis Index) total score (score 0-96) was measured in study visit 1(0 week) and visit 3(12 week). The original index consists of 24 Questions. Individual question response is assigned a score of between 0 (none) to 4 (extreme) and summed to form a score ranging from 0 (best) to 96 (worst).

Outcome measures

Outcome measures
Measure
Omija Extract
n=28 Participants
Oral intake Omija extract(1.2g/day) for 12weeks.
Placebo
n=28 Participants
Oral intake placebo(1.2g/day) for 12weeks
Changes in WOMAC (Western Ontario and McMaster University Osteoarthritis Index) Totol Score
Visit 1(0 week)
56.0 Score
Standard Deviation 11.6
53.3 Score
Standard Deviation 11.3
Changes in WOMAC (Western Ontario and McMaster University Osteoarthritis Index) Totol Score
visit 3(12 week)
34.8 Score
Standard Deviation 17.2
31.5 Score
Standard Deviation 15.5

SECONDARY outcome

Timeframe: 12 weeks

Population: per protocol analysis

Lysholm index score total score (score 0-100) was measured in study visit 1(0 week) and visit 3(12 week). The original index consists of 9 Questions(Limp, Assive devices, Up stair, Giving way, Sauat, Sit down\&up, Cripitation, Swelling, Pain). Lysholm index score total score summed to form a score ranging from 0 (worst) to 100 (best).

Outcome measures

Outcome measures
Measure
Omija Extract
n=28 Participants
Oral intake Omija extract(1.2g/day) for 12weeks.
Placebo
n=28 Participants
Oral intake placebo(1.2g/day) for 12weeks
Changes in Lysholm Index Score
Visit 1(0 week)
52.6 units on a scale(0-100)
Standard Deviation 11.0
48.3 units on a scale(0-100)
Standard Deviation 13.1
Changes in Lysholm Index Score
Visit 3(12 week)
54.8 units on a scale(0-100)
Standard Deviation 10.8
59.9 units on a scale(0-100)
Standard Deviation 15.6

SECONDARY outcome

Timeframe: 12 weeks

Population: per protocol analysis

hs-CRP(high sensitivity C-reactive protein) was measured in study visit 1(0 week) and visit 3(12 week).

Outcome measures

Outcome measures
Measure
Omija Extract
n=28 Participants
Oral intake Omija extract(1.2g/day) for 12weeks.
Placebo
n=28 Participants
Oral intake placebo(1.2g/day) for 12weeks
Changes in Hs-CRP(High Sensitivity C-reactive Protein)
Visit 1(0 week)
0.3 mg/L
Standard Deviation 0.4
1.2 mg/L
Standard Deviation 4.3
Changes in Hs-CRP(High Sensitivity C-reactive Protein)
Visit 3(12 week)
0.5 mg/L
Standard Deviation 0.9
0.6 mg/L
Standard Deviation 1.1

SECONDARY outcome

Timeframe: 12 weeks

Population: per protocol analysis

OSC(Osteocalcin) was measured in study visit 1(0 week) and visit 3(12 week).

Outcome measures

Outcome measures
Measure
Omija Extract
n=28 Participants
Oral intake Omija extract(1.2g/day) for 12weeks.
Placebo
n=28 Participants
Oral intake placebo(1.2g/day) for 12weeks
Changes in OSC(Osteocalcin)
Visit 1(0 week)
16.5 ng/ml
Standard Deviation 6.2
16.6 ng/ml
Standard Deviation 7.0
Changes in OSC(Osteocalcin)
Visit 3(12 week)
16.8 ng/ml
Standard Deviation 5.3
17.3 ng/ml
Standard Deviation 7.4

SECONDARY outcome

Timeframe: 12 weeks

Population: per protocol analysis

DPD(Deoxypyridinoline) was measured in study visit 1(0 week) and visit 3(12 week).

Outcome measures

Outcome measures
Measure
Omija Extract
n=28 Participants
Oral intake Omija extract(1.2g/day) for 12weeks.
Placebo
n=28 Participants
Oral intake placebo(1.2g/day) for 12weeks
Changes in DPD(Deoxypyridinoline)
Visit 1(0 week)
7.3 nanoMolar DPD per milliMolar creatine
Standard Deviation 2.5
7.2 nanoMolar DPD per milliMolar creatine
Standard Deviation 2.7
Changes in DPD(Deoxypyridinoline)
Visit 3(12 week)
7.2 nanoMolar DPD per milliMolar creatine
Standard Deviation 1.9
7.5 nanoMolar DPD per milliMolar creatine
Standard Deviation 2.0

Adverse Events

Omija

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. Jeong-Hwan Seo, MD

Clinical Trial Center for Functional Foods; Chonbuk National University Hospital

Phone: 82-63-276-8284

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place