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

• Sponsor: Chonbuk National University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01472822
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Duration (Months): 9
• Patients Per Site Per Month: 6.6

Study Details

Study Description

Brief Summary

Knee osteoarthritis (KO) is a common arthropathy and a leading cause of disability in elderly adults. Schizandra chinensis(Omija) has been known to have five predominant tastes: salty, sweet, sour, astringent, and bitter. It has also been shown to have various effects on the anti-inflammatory, cardiovascular system, gastrointestinal system, central nervous system, endocrine system, and stress protect. Therefore, this study is designed to evaluate the efficacy and safety on KO of Omija extract.

Condition or Disease	Intervention/Treatment	Phase
Mild Knee Osteoarthritis	Dietary Supplement: Omija extract.; Dietary Supplement: Placebo	Phase 2/Phase 3

Detailed Description

In the present study, the investigators will assess the efficacy and safety of the formulation of Omija extract(1,200 mg administered twice a day) on the symptoms of knee osteoarthritis (KO) during a 12-week treatment course. In a randomized, double-blind placebo-controlled trial, subjects will be randomly assign to receive oral omija treatment group(n=30) or placebo group(n=30). The primary efficacy outcome measure will be score change in the WOMAC(Western Ontario and McMaster University Osteoarthritis Index) after 12-weeks. Secondary parameters will be included the Lysholm index score, hs-CRP, osteocalcin(OSC), and deoxypyridinoline(DPYR).

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Prevention
• Official Title: Efficacy and Safety of Omija Extract on Gonarthritis
• Study Start Date: Mar 1, 2011
• Actual Primary Completion Date: Jun 1, 2011
• Actual Study Completion Date: Dec 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Omija extract.	Dietary Supplement: Omija extract.; Omija extract 1.2g/day for 12weeks
Placebo Comparator: Placebo	Dietary Supplement: Placebo; Placebo 1.2g/day for 12weeks

Outcome Measures

Primary Outcome Measures

1. Changes in WOMAC (Western Ontario and McMaster University Osteoarthritis Index) Totol Score [12 weeks]

   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).

Secondary Outcome Measures

1. Changes in Lysholm Index Score [12 weeks]

   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).

2. Changes in Hs-CRP(High Sensitivity C-reactive Protein) [12 weeks]

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

3. Changes in OSC(Osteocalcin) [12 weeks]

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

4. Changes in DPD(Deoxypyridinoline) [12 weeks]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Males and females 30-70 years old

• mild to Moderate KO(Knee Osteoarthritis) as indicated by WOMAC(Western Ontario and McMaster University Osteoarthritis Index) score ≥ 38

• Able to walk

• Subject agrees not to start any new therapies for OA during the course of the study

• Able to give informed consent

Exclusion Criteria:

• History of underlying inflammatory arthropathy; septic arthritis; inflammatory joint disease; gout; pseudogout; Paget's disease; joint fracture; acromegaly; fibromyalgia; Wilson's disease; ochronosis; haemochromatosis; heritable arthritic disorder or collagen gene mutations or rheumatoid arthritis

• Expectation of surgery in the next 4 months

• Recent injury in the area affected by OA of the knee, i.e. meniscal tear (past 4 months)

• Cartilage reconstruction procedure in the target knee

• Intra-articular corticosteroid injections in the target knee within the last 3 months

• Viscous injections in the target knee within the last 6 months

• Abnormal liver or kidney function tests (ALT or AST > 2 times the upper limit of normal; elevated creatinine, males>125 umol/L, females>110 umol/L)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinical Trial Center for Functional Foods; Chonbuk National University Hospital	Jeonju	Jeollabuk-do	Korea, Republic of	560-822

Sponsors and Collaborators

• Chonbuk National University Hospital

Investigators

• Principal Investigator: Jeong-Hwan Seo, MD, Chonbuk National University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Soo-Wan Chae, Clinical Trial Center for Functional Foods, Chonbuk National University Hospital
• ClinicalTrials.gov Identifier: NCT01472822
• Other Study ID Numbers: BIOYD-KA-SCHISANDRA
• First Posted: Nov 17, 2011
• Last Update Posted: Feb 4, 2013
• Last Verified: Dec 1, 2012

• Keywords provided by Soo-Wan Chae, Clinical Trial Center for Functional Foods, Chonbuk National University Hospital: Omija; knee osteoarthritis
• Additional relevant MeSH terms: Osteoarthritis; Osteoarthritis, Knee

Study Results

Participant Flow

Recruitment Details	Participants were recruited through local advertising and doctor referrals from hospital outpatients and general practice clinics.
Pre-assignment Detail	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.

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

Baseline Characteristics

Arm/Group Title	Omija	Placebo	Total
Arm/Group Description	Total of all reporting groups
Overall Participants	30	30	60
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	30 100%	30 100%	60 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	52.1 (9.5)	52.4 (9.6)	52.2 (9.5)
Sex: Female, Male (Count of Participants)
Female	27 90%	28 93.3%	55 91.7%
Male	3 10%	2 6.7%	5 8.3%
Region of Enrollment (participants) [Number]
Korea, Republic of	30 100%	30 100%	60 100%

Outcome Measures

1. Primary Outcome

Title	Changes in WOMAC (Western Ontario and McMaster University Osteoarthritis Index) Totol Score
Description	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).
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

per protocol analysis

Arm/Group Title	Omija Extract	Placebo
Arm/Group Description	Oral intake Omija extract(1.2g/day) for 12weeks.	Oral intake placebo(1.2g/day) for 12weeks
Measure Participants	28	28
Visit 1(0 week)	56.0 (11.6)	53.3 (11.3)
visit 3(12 week)	34.8 (17.2)	31.5 (15.5)

2. Secondary Outcome

Title	Changes in Lysholm Index Score
Description	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).
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

per protocol analysis

Arm/Group Title	Omija Extract	Placebo
Arm/Group Description	Oral intake Omija extract(1.2g/day) for 12weeks.	Oral intake placebo(1.2g/day) for 12weeks
Measure Participants	28	28
Visit 1(0 week)	52.6 (11.0)	48.3 (13.1)
Visit 3(12 week)	54.8 (10.8)	59.9 (15.6)

3. Secondary Outcome

Title	Changes in Hs-CRP(High Sensitivity C-reactive Protein)
Description	hs-CRP(high sensitivity C-reactive protein) was measured in study visit 1(0 week) and visit 3(12 week).
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

per protocol analysis

Arm/Group Title	Omija Extract	Placebo
Arm/Group Description	Oral intake Omija extract(1.2g/day) for 12weeks.	Oral intake placebo(1.2g/day) for 12weeks
Measure Participants	28	28
Visit 1(0 week)	0.3 (0.4)	1.2 (4.3)
Visit 3(12 week)	0.5 (0.9)	0.6 (1.1)

4. Secondary Outcome

Title	Changes in OSC(Osteocalcin)
Description	OSC(Osteocalcin) was measured in study visit 1(0 week) and visit 3(12 week).
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

per protocol analysis

Arm/Group Title	Omija Extract	Placebo
Arm/Group Description	Oral intake Omija extract(1.2g/day) for 12weeks.	Oral intake placebo(1.2g/day) for 12weeks
Measure Participants	28	28
Visit 1(0 week)	16.5 (6.2)	16.6 (7.0)
Visit 3(12 week)	16.8 (5.3)	17.3 (7.4)

5. Secondary Outcome

Title	Changes in DPD(Deoxypyridinoline)
Description	DPD(Deoxypyridinoline) was measured in study visit 1(0 week) and visit 3(12 week).
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

per protocol analysis

Arm/Group Title	Omija Extract	Placebo
Arm/Group Description	Oral intake Omija extract(1.2g/day) for 12weeks.	Oral intake placebo(1.2g/day) for 12weeks
Measure Participants	28	28
Visit 1(0 week)	7.3 (2.5)	7.2 (2.7)
Visit 3(12 week)	7.2 (1.9)	7.5 (2.0)

Adverse Events

Adverse Event Reporting Description	Serious and/or other [non-serious] adverse events were not collected/assessed
Arm/Group Title	Omija		Placebo
Arm/Group Description
All Cause Mortality
	Omija		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Omija		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/30 (0%)		0/30 (0%)
Other (Not Including Serious) Adverse Events
	Omija		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/30 (0%)		0/30 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.