Polycan in Combination With Glucosamine for Treatment of Knee Osteoarthritis

Osteoarthritis of the Knee Clinical Trial

Official title:

A Randomized, Double-blind, Active Controlled, 12-week Follow-up, Pilot Study to Evaluate the Safety and Efficacy of Polycan in Combination With Glucosamine for Treatment of Knee Osteoarthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03717714
• Other study ID #: Polycan-VN01
• Status: Completed
• Phase: N/A
• Start date: April 1, 2017
• Est. completion date: May 30, 2018

Study information

• Verified date: October 2018
• Source: Vietstar Biomedical Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objectives of this study is to examine the Safety and Efficacy of black yeast beta-glucan produced from Aureobusidium pulluluns SM-2001 (Polycan), in combination with glucosamine in reducing knee osteoarthritis (OA) associated symptoms. This study is a double-blind, randomized, active-controlled trial conducted with 100 OA patients, aged 35-80 years using a formulated product

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: May 30, 2018
• Est. primary completion date: May 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Confirmed diagnosis of knee osteoarthritis (OA)

• OA ranging from grade 1 to grade 3 by Kellgren and Lawrence system

• Agree to participate into the study

Exclusion Criteria:

• OA ranging from grade 4 by Kellgren and Lawrence system

• Allergic or contradicted with oral NSAIDs (Meloxicam)

• Pregnant and breastfeeding women.

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis of the Knee
• Osteoarthritis, Knee

Intervention

Dietary Supplement:
• Glucosamine 1500 mg
Patients in this group take 3 capsules, each capsule contains Placebo 16.7mg and Glucosamine 500 mg, once a day for 12 weeks
• Polycan 50mg + Glucosamine 750 mg
Patients in this group take 3 capsules, each capsule contains Polycan 16.7mg and Glucosamine 250 mg, once a day for 12 weeks
• Polycan 50mg + Glucosamine 1500 mg
Patients in this group take 3 capsules, each capsule contains Polycan 16.7mg and Glucosamine 500 mg, once a day for 12 weeks

Locations

Country	Name	City	State
Vietnam	198 Hospital	Hanoi

Sponsors (1)

Lead Sponsor	Collaborator
Vietstar Biomedical Research

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) changes at 12 weeks in the three groups	The WOMAC consists of 24 items divided into 3 subscales: Pain (5 items): during walking, using stairs, in bed, sitting or lying, and standing Stiffness (2 items): after first waking and later in the day Physical Function (17 items): stair use, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy household duties, light household duties.; Total WOMAC score ranges from 0 to 96 with higher scores indicate worse pain, stiffness, and functional limitations	Baseline to Week 12
Secondary	Number of dose of rescue medication (Meloxicam 7.5mg) used in the three groups.	Rescue medication (Meloxicam 7.5mg) used by patients for 12 weeks	Through study completion, an average of 12 weeks