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Synergistic effect of undenatured collagen type 2 supplementation and knee strengthening exercises in knee osteoarthritis

Protocol summary

Study aim
The study aims to evaluate the comparative effects of undenatured collagen type 2 supplementation, knee strengthening exercise program, on reducing pain and improving joint function in patients with osteoarthritis and degenerative changes.
Design
Pragmatic, community based, parallel group, double blinded, randomized controlled trial. Total 377 patients will be enrolled. Patients who met our inclusion criteria will be randomized into three groups.
Settings and conduct
Muhammad physical therapy clinic and rehabilitation center, Multan.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Adults aged between 35–65 years with mild-to-moderate knee osteoarthritis, knee pain for at least 3 months, able to perform physical activity and follow an exercise regimen, not taking any other osteoarthritis-related medications Exclusion Criteria: Presence of other types of arthritis, history of knee surgery or any intra-articular injections in the past 6 months, currently using immunosuppressive therapy , serious systemic diseases Pregnancy, breastfeeding, known allergy or intolerance to collagen supplements or any ingredients in the intervention product.
Intervention groups
Group 1: Will receive 40 mg/day of undenatured collagen type II supplementation. Group 2: Will be given a standardized knee-strengthening exercise program [specify duration and frequency, e.g., three times per week for 45 minutes]. Group 3: Will recieve UC-II supplementation and participated in the knee-strengthening exercise program..
Main outcome variables
Knee X rays; Western Ontario and McMaster Universities Osteoarthritis Index scale; Numeric Pain Rating Scale; Pain Catastrophizing Scale; Knee Range of Motion (goniometry); Knee injury outcome (KOOS); Muscle strength (dynamometer); Quality of life (SF-36); C-reactive protein; Interleukin-6

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230202057310N11
Registration date: 2024-12-22, 1403/10/02
Registration timing: prospective

Last update: 2024-12-22, 1403/10/02
Update count: 0
Registration date
2024-12-22, 1403/10/02
Registrant information
Name
Imran Ahmad Khan
Name of organization / entity
Muhammad Nawaz Shareef University of Agriculture, Multan
Country
Pakistan
Phone
+92 333 6120602
Email address
imran.ahmad@mnsuam.edu.pk
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-01-05, 1403/10/16
Expected recruitment end date
2025-04-05, 1404/01/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Synergistic effect of undenatured collagen type 2 supplementation and knee strengthening exercises in knee osteoarthritis
Public title
Undenatured collagen type 2 supplementation and knee strengthening exercises in knee osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Adults aged between 35–65 years. Diagnosed with mild-to-moderate knee osteoarthritis based on: Radiographic confirmation (Kellgren-Lawrence grade :1–3). Experiencing knee pain for at least 3 months Able to perform physical activity and follow an exercise regimen Willing to take undenatured collagen type II supplementation as prescribed Not taking any other osteoarthritis-related medications or willing to maintain a washout period of at least 2 weeks prior to enrollment Provided written informed consent to participate in the study.
Exclusion criteria:
1. Diagnosed with severe knee osteoarthritis (Kellgren-Lawrence grade 4). History of knee surgery or any intra-articular injections (e.g., corticosteroids, hyaluronic acid) in the past 6 months. Currently using immunosuppressive therapy or corticosteroids Pregnancy, breastfeeding, or planning to become pregnant during the study Presence of serious systemic diseases Known allergy or intolerance to collagen supplements or any ingredients in the intervention product Presence of other types of arthritis such as rheumatoid arthritis, gout, or infectious arthritis.
Age
From 35 years old to 65 years old
Gender
Both
Phase
1
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 377
Randomization (investigator's opinion)
Randomized
Randomization description
This randomization will be done by computer-generated numbers to ensure fairness. Medications will be given in numbered white boxes, each with a unique medication number. The treatment codes will be kept by the principal investigator.
Blinding (investigator's opinion)
Double blinded
Blinding description
Statistical analyser and outcome assessor will be kept blind so that the result obtained will be without biasness.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
The Institutional Ethical Committee of Muhammad Institute of Medical and Allied Sciences
Street address
Bosan Road
City
Multan
Postal code
66000
Approval date
2024-11-21, 1403/09/01
Ethics committee reference number
MIMAS/7/91/IAK

Health conditions studied

1

Description of health condition studied
Knee osteroarthritis
ICD-10 code
M19.0
ICD-10 code description
Primary osteoarthritis of other joints

Primary outcomes

1

Description
Osteophytes
Timepoint
12 weeks
Method of measurement
Knee Xray

2

Description
Pain, stiffness and ADLs
Timepoint
12 weeks
Method of measurement
NPRS and WOMAC Scale

3

Description
Knee ROM
Timepoint
12 weeks
Method of measurement
Goniometry

Secondary outcomes

1

Description
Knee injury outcome
Timepoint
12 weeks
Method of measurement
Knee injury outcome score (KOOS)

2

Description
Quality of life
Timepoint
12 weeks
Method of measurement
SF-36

Intervention groups

1

Description
Intervention group: Will receive 40 mg/day of undenatured collagen type II supplementation.
Category
Treatment - Drugs

2

Description
Intervention group: Will be given a standardized knee-strengthening exercise program [specify duration and frequency, e.g., three times per week for 45 minutes].The knee-strengthening exercise program focused on improving muscle strength, joint stability, and functional mobility. It included:• Warm-up: [e.g., 5 minutes of light cycling or walking].• Strengthening exercises: Quadriceps setting, hamstring curls, straight leg raises, and step-ups. Each exercise was performed in sets of 10 repetitions with progressive intensity over the study period.• Cool-down: [specify activities, e.g., 5 minutes of stretching or slow walking].Participants were supervised by trained physiotherapists to ensure adherence and proper technique.
Category
Rehabilitation

3

Description
Intervention group: Will recieve UC-II supplementation and participated in the knee-strengthening exercise program.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Muhammad Rehabilitation Centre, Multan
Full name of responsible person
Komal Ammar Bukhari
Street address
Multan
City
MULTAN
Postal code
66000
Phone
+92 333 6120602
Email
komalbukhari608@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Muhammad Institute of Medical and Allied Sciences, Multan, Pakistan
Full name of responsible person
Qurat Ul Ain
Street address
Bosan Road
City
Multan
Postal code
66000
Phone
+92 312 6827130
Email
qain0635@gmail.com
Grant name
Student fund
Grant code / Reference number
MIMAS/08/26/Kashifa
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Muhammad Institute of Medical and Allied Sciences, Multan, Pakistan
Proportion provided by this source
70
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Muhammad Institute of Medical and Allied Sciences, Multan, Pakistan.
Full name of responsible person
Maliha Khalid Khan
Position
Punjab
Latest degree
Medical doctor
Other areas of specialty/work
Physiotherapy
Street address
Multan
City
MULTAN
Province
Punjab
Postal code
66000
Phone
+92 333 6120602
Email
malihatareen1997@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Muhammad Nawaz Sharif University of Agriculture Multan
Full name of responsible person
Imran Ahmad Khan
Position
Punjab
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Old shuja Abad road Multan
City
Multan
Province
Punjab
Postal code
66000
Phone
+92 333 6120602
Email
imran.ahmad@mnsuam.edu.pk

Person responsible for updating data

Contact
Name of organization / entity
Muhammad Institute of Medical and Allied Sciences, Multan, Pakistan.
Full name of responsible person
Syeda Kashifa Shafaq
Position
Punjab
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Multan
City
MULTAN
Province
Punjab
Postal code
66000
Phone
+92 312 9634950
Email
kashifashafaqsyeda@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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