Knee OsteoarthritisNCT05321836
GLUCOSAMINE/CHONDROITIN and PHYSICAL THERAPY EFFECTS ON OLDER POPULATION WITH KNEE OSTEOARTHRITIS
A study testing Glucosamine Chondroitin and glucosamine chondritin & Physiotherapy in people with Knee Osteoarthritis, run by Muhammad salman, PT at 1 site in Pakistan.
Trial summary
to see the effect of glucosamine chondratin sulfate with and without physiotherapy in knee osteoarthritis Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Glucosamine Chondroitin and glucosamine chondritin & Physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 26 Jul 2021to 25 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: EFFECTS OF COMBINED GLUCOSAMINE/CHONDROITIN WITH STRUCTURED PHYSICAL THERAPY PROGRAM ON KNEE OSTEOARTHRITIS: A RANDOMIZED CONTROL TRAIL
to see the effect of glucosamine chondratin sulfate with and without physiotherapy in knee osteoarthritis
Read the 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
- Conditions
- Knee Osteoarthritis
- Being tested
- Glucosamine Chondroitin, glucosamine chondritin & Physiotherapy
- Keywords
- OA, Chondratin sulfate, glucosamine, Physiotherapy
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glucosamine ChondroitinOther
control group
glucosamine chondritin & PhysiotherapyCombination product
experimental group
| Study group | Role | What they receive |
|---|---|---|
| control group | Active comparator | chondritin sulfate 1500/1200mg Receives: Other: Glucosamine Chondroitin |
| experimental group | Experimental | chondritin sulfate plus physiotherapy Receives: Combination Product: glucosamine chondritin & Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
WOMAC
higher score means worst patient condition and lower score means better
Measured: 6 months
Secondary outcomes (1)
SF-36
higher score means better patient condition and lower score means worst
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2022
- Study start26 Jul 2021
- Primary completion25 Mar 2022
- Study completion25 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- two groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Muhammad salman, PT
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Muhammad salman, PT, Neuro Counsel Hospital, Pakistan
- Investigators
- MUHAMMAD UMAR, Principal investigator, the physiotherapy clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05321836
- Sponsor's protocol ID
- 333
- Status last verified
- Apr 2022
- First submitted
- 26 Mar 2022
- Last updated
- 11 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECTS OF COMBINED GLUCOSAMINE/CHONDROITIN WITH STRUCTURED PHYSICAL THERAPY PROGRAM ON KNEE OSTEOARTHRITIS: A RANDOMIZED CONTROL TRAIL
- ClinicalTrials.gov ID
- NCT05321836
- Acronym / sponsor ID
- 333
- Conditions
- Knee Osteoarthritis
- Keywords
- OA, Chondratin sulfate, glucosamine, Physiotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Muhammad salman, PTUniversity, hospital or other
- Study start
- 26 Jul 2021 (actual)
- Primary completion
- 25 Mar 2022 (actual)
- Study completion
- 25 Mar 2022 (actual)
- First posted
- 11 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- two groups
| Arm | Type | Receives |
|---|---|---|
| control group | Active comparator | Other: Glucosamine Chondroitinchondritin sulfate 1500/1200mg |
| experimental group | Experimental | Combination Product: glucosamine chondritin & Physiotherapychondritin sulfate plus physiotherapy |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glucosamine Chondroitincontrol group | Other | control group |
| glucosamine chondritin & Physiotherapyexperimental group | Combination product | experimental group |
Primary outcome
WOMAC
Time frame: 6 months
higher score means worst patient condition and lower score means better
1 secondary outcome
SF-36
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2022.
- Individual participant dataSharing planned: No
Related trials for Knee Osteoarthritis
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
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Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MUHAMMAD UMAR principal investigator
the physiotherapy clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glucosamine Chondroitin and glucosamine chondritin & Physiotherapy in people with Knee Osteoarthritis, run by Muhammad salman, PT at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
WOMAC (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2022.