NCT05321836

Brief Summary

to see the effect of glucosamine chondratin sulfate with and without physiotherapy in knee osteoarthritis

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Jul 2021

Shorter than P25 for not_applicable knee-osteoarthritis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 26, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 25, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 25, 2022

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

March 26, 2022

Completed
16 days until next milestone

First Posted

Study publicly available on registry

April 11, 2022

Completed
Last Updated

April 11, 2022

Status Verified

April 1, 2022

Enrollment Period

8 months

First QC Date

March 26, 2022

Last Update Submit

April 4, 2022

Conditions

Keywords

OA, Chondratin sulfate, glucosamine, Physiotherapy

Outcome Measures

Primary Outcomes (1)

  • WOMAC

    higher score means worst patient condition and lower score means better

    6 months

Secondary Outcomes (1)

  • SF-36

    6 months

Study Arms (2)

control group

ACTIVE COMPARATOR

chondritin sulfate 1500/1200mg

Other: Glucosamine Chondroitin

experimental group

EXPERIMENTAL

chondritin sulfate plus physiotherapy

Combination Product: glucosamine chondritin & Physiotherapy

Interventions

control group

control group

experimental group

experimental group

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Muhammad Umar

Rawalpindi, Punjab Province, 46030, Pakistan

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Officials

  • MUHAMMAD UMAR

    the physiotherapy clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: two groups
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal researcher

Study Record Dates

First Submitted

March 26, 2022

First Posted

April 11, 2022

Study Start

July 26, 2021

Primary Completion

March 25, 2022

Study Completion

March 25, 2022

Last Updated

April 11, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations