| CTRI Number |
CTRI/2024/02/062580 [Registered on: 13/02/2024] Trial Registered Prospectively |
| Last Modified On: |
10/05/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Clinical study on knee joint health in adult subjects |
|
Scientific Title of Study
|
A randomized double-blind placebo controlled clinical study for the comparative evaluation of efficacy and tolerability of proteoglycan in improving knee joint health in adult subjects with mild osteoarthritis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Daehan/Proteoglycan/Joint Health/2023 Ver1.0Date:22Nov2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Manju Jayaram |
| Designation |
Principal investigator |
| Affiliation |
Kempegowda Institute of Medical Sciences |
| Address |
Ground floor Department of Orthopaedics KR Road, Parvathipuram,
Vishweshwarapura, Basavanagudi, Bengaluru
Bangalore
KARNATAKA
560004
India |
| Phone |
9845037194 |
| Fax |
|
| Email |
drmanjujairam@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vijendra R |
| Designation |
Head-Medical services |
| Affiliation |
Bangalore Clinical Services |
| Address |
Novel Tech Park No 46/4 Ground floor, Hosur Road, Kudlu Gate
Bengaluru-560 068 Karnataka, India
Bangalore
KARNATAKA
560068
India |
| Phone |
9980033334 |
| Fax |
|
| Email |
clinical@bangaloreclinicalservices.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vijendra R |
| Designation |
Head-Medical services |
| Affiliation |
Bangalore Clinical Services |
| Address |
Novel Tech Park No 46/4 Ground floor, Hosur Road, Kudlu Gate
Bengaluru-560 068 Karnataka, India
KARNATAKA
560068
India |
| Phone |
9980033334 |
| Fax |
|
| Email |
clinical@bangaloreclinicalservices.com |
|
|
Source of Monetary or Material Support
|
| Daehan chemtech co., Ltd B-1208, 65, Gwacheon-Daero 7-Gil Gwacheon-Si, Gyeonggi-Do
13840, South Korea |
|
Primary Sponsor
Modification(s)
|
| Name |
Daehan Chemtech Co Ltd |
| Address |
B-1208, 65, Gwacheon-Daero 7-Gil Gwacheon-Si, Gyeonggi-Do 13840, South Korea |
| Type of Sponsor |
Other [Nutraceutical supplement company] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Manju Jayaram |
Kempegowda Institute of Medical Sciences |
Ground floor
Department of
Orthopaedics KR Road,
Parvathipuram,
Vishweshwarapura,
Basavanagudi,
Bengaluru, Karnataka -
560004, India
Bangalore
KARNATAKA |
9845037194
drmanjujairam@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe-Kempegowd a Institute of Medical Sciencese |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M171||Unilateral primary osteoarthritisof knee, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo |
Dose: 40mg Dosage form: Capsule Route of administration: Orally Frequency: One capsule orally in the morning before breakfast |
| Intervention |
Proteoglycan |
Dose: 40mg
Dosage form: Capsule
Route of administration: Orally
Frequency: One capsule orally in the morning before breakfast
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1.Ambulatory, male and female subjects 40-75 years of age.
2.KL (Kellgren-Lawrence) grade of 1 to 2.
3.At least 30 on 100 mm visual analogue scale.
4.Subjects having mild-to-moderate pain in knee joint upon completion of 30-second Chair Stand Test or 80-meter Fast-Paced Walk Test, and otherwise no knee pain at rest.
5.Subjects willing to refrain from taking ibuprofen, aspirin or other NSAIDs or any other pain reliever (OTC or prescription) during the entire trial.
6.Subjects willing to sign the informed consent and comply with study procedure.
7.Subjects able to complete 20-meter walk test. |
|
| ExclusionCriteria |
| Details |
1. Subjects with any possible signs / indication / history of arthritis,
joint disorders including dislocations and quadriceps tendons tear.
2. Subjects with history of underlying inflammatory arthropathy or
severe RA or OA.
3.Subjects having used any immunosuppressive drugs in the last 6
months (including steroids or biologics) and those with history of
immune system and autoimmune disorders.
4.Subjects with a history of knee or hip joint replacement surgery, or
any hip or back pain which interferes with ambulation.
5.Subjects with BMI less than 18.5 or more than 30.
6.Subjects who consumed the medicines or supplements related
with joint health within 30 days before screening visit.
7.Subjects who are not acceptable for the test by the judgment of PI.
8.Subjects with the history of tobacco smoking.
9.Subjects expecting the surgery during the study duration period.
10.Female subjects, who are pregnant, breast feeding or planning to
become pregnant.
11.Subjects having known allergy to non-steroidal anti-inflammatory
drugs (NSAIDs) (including aspirin) or has a suspected
hypersensitivity, allergy or sensitivity to herbal products.
12.Subjects who have any physical disability which could interfere
with their ability to perform the functional performance measures
included in this protocol.
13.Subjects with history of gout.
14.Subjects who have received any corticosteroids, NSAIDs,
glucosamine, and or chondroitin, within the past 90 days prior to the
screening visit or any form of intra-articular treatment / injections with
corticosteroids or hyaluronic acid within 90 days preceding the
screening visit.
15.Subjects with the history of congestive heart failure or any
vascular conditions.
16.Subjects with the evidence or history of clinically significant (in the
judgment of the Investigator) hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular, hepatic or neurologic
diseases, or malignancies, hypothyroidism.
17.Subjects with history of systemic lupus erythematous (SLE).
18.Subjects with history of high alcohol intake (greeter than 2
standard drinks per day).
19.Subjects with history of any psychiatric disorders that may impair
the ability of subjects to provide written informed consent.
20.Subjects who have participated in any other trials involving
investigational or marketed products within 90 days prior to the
screening visit.
21.Subjects who are currently or within 30 days prior to the screening visit on prescription or OTC medications / pain relievers
such as acetaminophen / paracetamol, ibuprofen, aspirin or other
NSAIDs or any natural health product, (excluding vitamins). |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Change in WOMAC total score from baseline
to Day 30, 60 and 90.
2. Change in WOMAC sub-score: pain, stiffness,
physical function from baseline to Day 30, 60
and 90.
3. Pain VAS from baseline to Day 30, 60 and 90.
4. Lequesne Functional Index from baseline to
Day 30, 60 and 90. |
Day 0,Day 30,Day 60 and Day 90 |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
1. Change in 20-meter walking time from baseline to Day 30, 60 & 90.
2. Change in Joint space narrowing (width) from baseline to Day 30, 60 & 90.
3. Swelling (in the knee joint) index score from baseline to Day 30, 60 & 90.
4. Change in SF-36 score from baseline to Day 30, 60 & 90.
5. Change in TNF-alpha levels from baseline to Day 90.
6. Change in COX levels from baseline to Day 90.
7. Change in cartilage oligomeric matrix protein (COMP) levels from baseline to Day 90.
8. Change in C-Reactive Protein levels from baseline to Day 90.
9. Adverse events (AEs).
10. Abnormal findings in vital signs & medical interviews.
11. Abnormal changes in the hematology/blood chemistry test results |
Day0 Day 30 Day 60 & Day 90
Biomarkers & hematology/blood chemistry test
results- Day 0 & Day 90 |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
Final Enrollment numbers achieved (Total)= "150"
Final Enrollment numbers achieved (India)="150" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
15/02/2024 |
| Date of Study Completion (India) |
06/11/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
there are numerous pharmacological classes available to treat osteoarthritis, each class of drug has its unique profile of unfavorable side effects. Many medications simply treat the symptoms and not the underlying causes that allow for illness progression. Because OA is chronic in nature and therapy takes longer, safer and more potent medications are required. Despite the enormous advancements in medical research over the past century, osteoarthritis is still poorly managed. As osteoarthritis is a complex and interlinked clinical disease where there is anatomical and immunological abnormality which turns into a vicious cycle, a therapy which addresses both these abnormalities is always sought for. Medications which can halt the progression of osteoarthritis, particularly when administered in stage 0 and stage 1 osteoarthritis, are needed. Hence the quest for novel medications continues which can address osteoarthritis in a holistic approach of disease management. Proteoglycans distributed across tissues and cellular compartments play pivotal roles in development, tissue maintenance, and disease pathogenesis. Their significance in cartilage health and osteoarthritis underscores their potential as therapeutic targets, necessitating further research for a comprehensive understanding and potential interventions.
The primary objectives of this study are to evaluate the efficacy and safety of proteoglycan in the treatment of osteoarthritis (OA) compared to a placebo. The study aims to assess various efficacy outcomes, including primary efficacy outcomes of changes in WOMAC total score, WOMAC sub-scores (pain, stiffness, physical function), pain VAS, and Lequesne Functional Index. The secondary efficacy outcomes include evaluation of change in in 20-meter walking time; change in joint space (width) narrowing; change in swelling index score; change in scores of the SF-36 questionnaire; change in TNF-alpha levels; change in COX levels; and change in C-reactive protein levels. The safety of proteoglycan and the placebo will also be closely monitored throughout the study. |