GLUCOSAMINE/CHONDROITIN and PHYSICAL THERAPY EFFECTS ON O... | NCT05321836

Studies
GLUCOSAMINE/CHONDROITIN and PHYSICAL THERAPY EFFECTS ON OLDER POPULATION WITH KNEE OSTEOARTHRITIS

NCT05321836

Sponsor

Muhammad salman, PT

Status

Completed

Last Update Posted

Apr 11, 2022Actual

Enrollment

30Actual

Phase

Not Applicable

Conditions

Knee Osteoarthritis

Interventions

Glucosamine Chondroitin
glucosamine chondritin & Physiotherapy

Countries

Pakistan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 26, 2021Actual

Primary Completion Date

Mar 25, 2022Actual

Completion Date

Mar 25, 2022Actual

First Submitted Date

Mar 26, 2022

First Submission Date that Met QC Criteria

Apr 4, 2022

First Posted Date

Apr 11, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 4, 2022

Last Update Posted Date

Apr 11, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
control group	Active Comparator	chondritin sulfate 1500/1200mg	Other: Glucosamine Chondroitin
experimental group	Experimental	chondritin sulfate plus physiotherapy	Combination Product: glucosamine chondritin & Physiotherapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Glucosamine Chondroitin	Other	control group	control group
glucosamine chondritin & Physiotherapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
WOMAC	higher score means worst patient condition and lower score means better	6 months

Secondary Outcomes

Measure	Description	Time Frame
SF-36	higher score means better patient condition and lower score means worst	6 months

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
MUHAMMAD UMAR	the physiotherapy clinic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Muhammad Umar		Rawalpindi	Punjab Province	46030	Pakistan

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D020370	Osteoarthritis, Knee

Ancestor Terms

ID	Term
D010003	Osteoarthritis
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D026741	Physical Therapy Modalities

Ancestor Terms

ID	Term
D013812	Therapeutics
D012046	Rehabilitation

Browse Leaves

Not provided

Browse Branches

Not provided