Back to resultsGLUCOSAMINE/CHONDROITIN and PHYSICAL THERAPY EFFECTS ON OLDER POPULATION WITH KNEE OSTEOARTHRITIS
Primary Purpose
Knee Osteoarthritis
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Glucosamine Chondroitin
glucosamine chondritin & Physiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis focused on measuring OA, Chondratin sulfate, glucosamine, Physiotherapy
Eligibility Criteria
Inclusion Criteria:
- age > 50 years with radiographic evidence of mild to moderate knee OA (Kellgren Lawrence grade II & III 20) who met the ACR clinical 21,
- radiographic classification criteria or confirmation of mild to moderate radiographic evidence of knee OA from a personal physician
- not currently participating in another intervention study
Exclusion Criteria:
- dementia (Mini-Mental State Examination [MMSE]< 24)
- active cancer other than skin cancer
- anemia (participants with an hematocrit (HCT)< 32 (or a hemoglobin below10) were excluded due to possible inability to adequately exercise or the increased potential for increased risk for serious adverse cardiovascular events)
- severe renal insufficiency (serum creat> 2)
- hepatic disease
Sites / Locations
- Muhammad Umar
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
control group
experimental group
Arm Description
chondritin sulfate 1500/1200mg
chondritin sulfate plus physiotherapy
Outcomes
Primary Outcome Measures
WOMAC
higher score means worst patient condition and lower score means better
Secondary Outcome Measures
SF-36
higher score means better patient condition and lower score means worst
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05321836
Brief Title
GLUCOSAMINE/CHONDROITIN and PHYSICAL THERAPY EFFECTS ON OLDER POPULATION WITH KNEE OSTEOARTHRITIS
Official Title
EFFECTS OF COMBINED GLUCOSAMINE/CHONDROITIN WITH STRUCTURED PHYSICAL THERAPY PROGRAM ON KNEE OSTEOARTHRITIS: A RANDOMIZED CONTROL TRAIL
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
July 26, 2021 (Actual)
Primary Completion Date
March 25, 2022 (Actual)
Study Completion Date
March 25, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Muhammad salman, PT
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
to see the effect of glucosamine chondratin sulfate with and without physiotherapy in knee osteoarthritis
Detailed Description
it is a randomized control trail to evaluate the effectiveness of glucosamine chondratin sulfate alone and in combination with physiotherapy on knee osteoarthritis
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
OA, Chondratin sulfate, glucosamine, Physiotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
two groups
Masking
Participant
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
control group
Arm Type
Active Comparator
Arm Description
chondritin sulfate 1500/1200mg
Arm Title
experimental group
Arm Type
Experimental
Arm Description
chondritin sulfate plus physiotherapy
Intervention Type
Other
Intervention Name(s)
Glucosamine Chondroitin
Intervention Description
control group
Intervention Type
Combination Product
Intervention Name(s)
glucosamine chondritin & Physiotherapy
Intervention Description
experimental group
Primary Outcome Measure Information:
Title
WOMAC
Description
higher score means worst patient condition and lower score means better
Time Frame
6 months
Secondary Outcome Measure Information:
Title
SF-36
Description
higher score means better patient condition and lower score means worst
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
age > 50 years with radiographic evidence of mild to moderate knee OA (Kellgren Lawrence grade II & III 20) who met the ACR clinical 21,
radiographic classification criteria or confirmation of mild to moderate radiographic evidence of knee OA from a personal physician
not currently participating in another intervention study
Exclusion Criteria:
dementia (Mini-Mental State Examination [MMSE]< 24)
active cancer other than skin cancer
anemia (participants with an hematocrit (HCT)< 32 (or a hemoglobin below10) were excluded due to possible inability to adequately exercise or the increased potential for increased risk for serious adverse cardiovascular events)
severe renal insufficiency (serum creat> 2)
hepatic disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MUHAMMAD UMAR
Organizational Affiliation
the physiotherapy clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Muhammad Umar
City
Rawalpindi
State/Province
Punjab
ZIP/Postal Code
46030
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
GLUCOSAMINE/CHONDROITIN and PHYSICAL THERAPY EFFECTS ON OLDER POPULATION WITH KNEE OSTEOARTHRITIS
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