| CTRI Number |
CTRI/2024/02/062371 [Registered on: 07/02/2024] 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 chondroitin sulfate in improving knee joint health in adult subjects with mild osteoarthritis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| DH/Chondroitin/Joint Health/2023 Ver 1.0 Date 14 Nov 2023 |
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 Room number 3
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 |
DrVijendra 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
560 068
India |
| Phone |
9980033334 |
| Fax |
|
| Email |
clinical@bangaloreclinicalservices.com |
|
Details of Contact Person
Public Query
|
| Name |
DrVijendra 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
560 068
India |
| Phone |
9980033334 |
| Fax |
|
| Email |
clinical@bangaloreclinicalservices.com |
|
|
Source of Monetary or Material Support
|
| 1. Daehan chemtech co., Ltd address: B-1208, 65, Gwacheon-Daero 7-Gil Gwacheon-Si, Gyeonggi-Do 13840, South Korea).
2. Zeria group (ZPD A/S) address: H. E. Bluhmes vej 63 6700 Esbjerg, Denmark).
|
|
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
Modification(s)
|
| Name |
Address |
| ZPD Part of Zeria Group |
H E Bluhmes Vej 63, 6700 Esbjerg, Denmark |
|
|
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
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KIMS Institutional Ethics Committee |
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 |
| Intervention |
Chondroitin sulfate sodium (ScanDroitinâ„¢) |
Dose: 600mg
Dosage form: Tablets
Route of administration: Orally
Frequency:Two tablets orally in the morning before breakfast for a total daily dose of 1,200 mg
Duration:90 Days |
| Comparator Agent |
Placebo |
Dose: 600mg Dosage form: Tablets Route of administration: Orally Frequency:Two tablets orally in the morning before breakfast for a total daily dose of 1,200 mg
Duration:90 Days |
|
Inclusion Criteria
Modification(s)
|
| 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 the 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)
|
09/02/2024 |
| Date of Study Completion (India) |
10/09/2024 |
| 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
|
Chondroitin sulfate is a natural glycosaminoglycan with a wide range of biological effects on articular tissues. It has been extensively researched for its potential in the treatment of osteoarthritis, with evidence suggesting that it may help alleviate pain and improve function in OA patients. Additionally, it has demonstrated potential as a disease-modifying agent by slowing cartilage volume loss and joint space narrowing in some studies. However, the efficacy of CS can vary depending on factors such as dosage, purity, and source, making it important to use high-quality pharmaceutical-grade CS products in clinical practice. Future research should continue to explore the mechanisms of action of CS and its potential as a therapeutic agent for osteoarthritis, with a focus on safety and product quality to ensure positive patient outcomes. The present study is designed to confirm the efficacy and safety of chondroitin sulfate on mild osteoarthritic.
The present study is designed to confirm the efficacy and safety of chondroitin sulfate on mild osteoarthritic individuals with the study title—“A randomized double-blind placebo controlled clinical study for the comparative evaluation of efficacy and tolerability of chondroitin sulfate in improving knee joint health in adult subjects with mild osteoarthritis |