Knee Osteoarthritis (OA)NCT06917287
A Clinical Study to Evaluate the Efficacy of Native CT-II® in Individuals With Knee Osteoarthritis
A study testing Native CT-II® (undenatured type II collagen) and Glucosamine HCL + Chondroitin Sulphate (G+C) [Comparator] in people with Knee Osteoarthritis (OA), run by Vedic Lifesciences Pvt. Ltd. at 5 sites in India.
Trial summary
This randomized, double-blind, placebo-controlled clinical study evaluates the efficacy of Native CT-II® (undenatured type II collagen) in individuals with knee osteoarthritis using a parallel design.Participants are assigned to one of three groups: Group 1 receives Native CT-II® (40 mg daily individed doses), Group 2… Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Knee Osteoarthritis (OA)
- What is being tested?
- Native CT-II® (undenatured type II collagen) and Glucosamine HCL + Chondroitin Sulphate (G+C) [Comparator]
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 114 participants
- Where
- 5 sitesIndia
- Study dates
- 20 Apr 2025to 26 Mar 2026
- 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 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1.Individuals ready to give voluntary, written informed consent to participate in the study.
- 2.Males and females of age between 40 to 65 years (including both values) suffering from Knee Osteoarthritis under no medications.
- 3.Body mass index (BMI) between 18.5 to 29.9 kg/m2 (including both values). 4.mWOMAC total score ≥ 75. 5. Individuals with knee pain having VAS score of greater than or equal to 60 mm on a 100 mm VAS scale.
- 6.Radiographic evidence (lateral and anterio-posterior weight-bearing standing X-ray) of grade II/III (in 2: 1 ratio) knee Osteoarthritis (OA) for index joint (The knee with the higher pain score will be designated as the index joint for the study) based on the Kellgren and Lawrence (K\&L) radiographic entry criteria for OA -
- Grade II: Possible joint space narrowing (JSN) with definite osteophyte formation.
- Grade III: Definite joint space narrowing, multiple osteophyte formations, some sclerosis, and possible deformity of bony ends.
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- 7.Individuals with a history of symptomatic knee joint pain of at least 3 months.
- 8.Non-vegetarians (regardless of whether they eat chicken, fish, goat mutton, pork, beef or eggs) 9.Willing to abstain from food (fish, meat, bone broth, eggs, etc) containing Type II collagen from cartilage 48 h before all assessment visits.
- 10.Willing to stop using rescue medication 48 hours prior to every assessment visits.
- 11.Willing to stop the restricted dietary supplements, home-based remedies, and any other form of topical products or medications (mainly includes NSAIDs and local analgesics, DMARD, corticosteroids, etc) for knee joint pain relief or any other reason for the entire study duration.
- (Note: only hot and cold fomentation will be allowed, and the participant has to record the daily frequency of fomentation in the diary. The hot/cold fomentation needs to be stopped 48 hours prior to all assessment visits.).
- 12.Individuals using the western toilet at home and/or workplace. 13.Willing to abstain from alcohol, caffeine, and vigorous physical activity for 24 hours before every study visit.
- 14.Willingness to participate and comply with the study procedures and required visits.
Who cannot join
- 1.Individuals who have been injured near the knee joint region in the past six months.
- 2.Individuals with a history of knee surgery, replacement or any non-knee surgical procedures that may impact the study outcomes.
- 3.Individuals who have used intra-articular injections, platelet replacement therapy, stem cell therapy and or steroids for joint health issues in the last six months.
- 4.Individuals who have any other chronic disease or condition, or inflammatory disease conditions and/ or are using any medication or dietary supplements or ayurvedic medications or topical ointment/oil/gel for joint health that in the judgment of the Investigator would put the individual at unacceptable risk for an individual in the study or may interfere with evaluations in the study or noncompliance with treatment or visits.
- 5.History or presence of clinically significant renal, hepatic, endocrine, biliary, gastrointestinal, pancreatic, or neurological disorders, that in the judgment of the Investigator, would interfere with the individual's ability to provide informed consent, comply with the study protocol (which might confound the interpretation of the study results), or put the individual at undue risk.
- 6.History of uncontrolled hypertension and/or systolic blood pressure more than or equal to 140 mmHg and/or diastolic blood pressure more than or equal to 90 mmHg.
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- 7.Fasting blood glucose (FBG) more than or equal to 126 mg/dl 8.Known cases of gout and/or hyperuricemia 9.Any history or evidence of allergy to chicken, shellfish, eggs or protein products in the past.
- 10.Use of collagen supplements (as dietary supplements) 11.History of bleeding disorders (e.g. Hemophilia, sickle cell anemia) 12.Other pathologic lesions on X-ray of the knee. 13.Any other condition that would prohibit completion of the exercise protocols.
- 14.Individuals who have participated in a clinical study with an Investigational product within 90 days before pre-screening, and who plan to participate in another study during the study period.
- 15.Not willing to abstain from the use of NSAIDs (including aspirin 50 mg/day for cardiovascular health).
- 16.Pregnant or Lactating females. 17.Individuals having a history of drug or alcohol abuse. 18.Current smokers
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
India5 sites
Proactive Othopedic Clinic
Mumbai, Maharashtra, 400053
Ayush Nursing Home
Mumbai, Maharashtra, 400067
Diamond Orthopedic & Multispeciality Hospital
Mumbai, Maharashtra, 400067
O2 Clinic
Nashik, Maharashtra, 422005
Sparsh Superspeciality Hospital
Panvel, Maharashtra, 410206
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Design Clinical Study to Evaluate the Efficacy of Native CT-II® in Individuals With Knee Osteoarthritis
This randomized, double-blind, placebo-controlled clinical study evaluates the efficacy of Native CT-II® (undenatured type II collagen) in individuals with knee osteoarthritis using a parallel design.Participants are assigned to one of three groups:
Group 1 receives Native CT-II® (40 mg daily individed doses), Group 2 receives Glucosamine HCL + Chondroitin Sulphate (2700 mg daily as acomparator), and Group 3 receives a placebo (Microcrystalline Cellulose). All participants take threecapsules after breakfast and three after dinner for 90 days . The study aims to screen approximately 142 participants
Read more
, randomizing around 114 (considering a 20% dropout rate), with a target of 90completed participants (30 per group). Osteoarthritis (OA) is a degenerative joint disorder causing pain, stiffness, and reduced mobility,primarily affecting older adults. It is a leading cause of disability, with knee OA being the mostprevalent form. The global burden of OA is rising due to aging populations and increasing obesityrates, necessitating improved treatment options. Current management focuses on symptom reliefthrough non-pharmacological (exercise, weight loss) and pharmacological (NSAIDs, analgesics)interventions, though these can have adverse effects.
Undenatured type II collagen (NCTII), derived from chicken sternum, has emerged as a potentialsupplement for joint health. It triggers an immune response that reduces inflammation and supportscartilage repair. Clinical studies show that NCTII improves joint function, pain, and quality of life,outperforming glucosamine and chondroitin with fewer side effects. A new study aims to evaluatethe efficacy of Native CT-II® in individuals with Grade II and III knee OA over 90 days, comparing itto glucosamine-chondroitin and placebo groups.
- Conditions
- Knee Osteoarthritis (OA)
- Being tested
- Native CT-II® (undenatured type II collagen), Glucosamine HCL + Chondroitin Sulphate (G+C) [Comparator], Placebo [Microcrystalline Cellulose (MCC)
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Native CT-II® (undenatured type II collagen)Dietary supplement
Strength: 40 mg in 3 capsules
Dose Regimen:
3 yellow capsules containing MCC after breakfast with water 3 blue capsules containing 40 mg Native CT-II® \& MCC after dinner with water Route of administration: Oral
Glucosamine HCL + Chondroitin Sulphate (G+C) [Comparator]Dietary supplement
2700 mg (1500 mg G + 1200 mg C) 3 yellow capsules containing G+C orally after breakfast with water \& 3 blue capsules containing G+C after dinner with water
Placebo [Microcrystalline Cellulose (MCC)Dietary supplement
2700 mg excipient 3 yellow capsules containing MCC orally after breakfast with water 3 blue capsules containing MCC after dinner with water.
| Study group | Role | What they receive |
|---|---|---|
| Native CT-II® (undenatured type II collagen) | Experimental | Strength: 40 mg in 3 capsules
Dose Regimen:
3 yellow capsules containing MCC after breakfast with water 3 blue capsules containing 40 mg Native CT-II® \& MCC after dinner with water Route of administration: Oral Receives: Dietary Supplement: Native CT-II® (undenatured type II collagen) |
| Glucosamine HCL + Chondroitin Sulphate (G+C) [Comparator] | Active comparator | Strength: 2700 mg (1500 mg G + 1200 mg C)
Dose Regimen:
3 yellow capsules containing G+C after breakfast with water 3 blue capsules containing G+C after dinner with water Route of administration: Oral Receives: Dietary Supplement: Glucosamine HCL + Chondroitin Sulphate (G+C) [Comparator] |
| Placebo [Microcrystalline Cellulose (MCC)] | Placebo comparator | Strength: 2700 mg excipient
Dose Regimen:
3 yellow capsules containing MCC after breakfast with water 3 blue capsules containing MCC after dinner with water Route of administration: Oral Receives: Dietary Supplement: Placebo [Microcrystalline Cellulose (MCC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the effect of consumption of Native CT-II on knee joint health asassessed by change in modified Western Ontario and McMaster UniversityOsteoarthritis Index total score as compared to baseline,Glucosamine HCL + Chondroitin Sulphate an
The primary efficacy variable for this study is the total mWOMAC index score. The scores from each subscale will be combined, with the pain subscale ranging from 0 to 20, the stiffness subscale from 0 to 8, and the physical function subscale from 0 to 80. Participants with knee OA will complete the mWOMAC index total score.
Measured: day 0, day 7, day 30, day 60 and day 90
Secondary outcomes (7)
To assess the effect of Native CT-II® in comparison to baseline, GlucosamineHCL + Chondroitin Sulphate and placebo on Knee joint pain as assessed bychange in mWOMAC - Pain subscale (mWOMAC-P) score.
The pain subscale (mWOMAC-P) of the mWOMAC index consists of 5 questions that assess the level of pain experienced by individuals with OA in the index joint. Responses are recorded using a 5-point likert scale, where higher scores correspond to greater pain. The scale ranges from 0 ("No pain") to 4 ("Extreme pain"), with the total score for mWOMAC-P ranging from 0 to 20. Participants with knee OA will complete the mWOMAC-P.
Measured: day 0, day 7, day 30, day 60 and day 90
To assess the effect of Native CT-II in comparison to baseline, GlucosamineHCL + Chondroitin Sulphate and placebo on Knee joint stiffness as assessedby change in mWOMAC - Stiffness subscale (mWOMAC-S) score.
The stiffness subscale (mWOMAC-S) of the mWOMAC index consists of 2 questions that assess the level of stiffness in the index joint, characterized by resistance to movement, along with pain and discomfort. Responses are recorded using a 5-point likert scale, where higher scores indicate greater stiffness. The scale ranges from 0 ("No stiffness") to 4 ("Extreme stiffness"), with the total score for mWOMAC-S ranging from 0 to 8. Participants with knee OA will complete the mWOMAC-S on day 0, day 7, day 30, day 60 and day 90 using the e-diary.
Measured: day 0, day 7, day 30, day 60 and day 90
To assess the effect of Native CT-II in comparison to baseline, GlucosamineHCL + Chondroitin Sulphate and placebo on Knee joint function as assessedby change in mWOMAC - Physical Function subscale (mWOMAC-PF) score.
The physical function subscale (mWOMAC-PF) of the mWOMAC index consists of 20 questions assessing the level of difficulty experienced in the index joint due to OA. Responses are recorded on a 5-point likert scale, where higher scores reflect greater functional impairment. The scale ranges from 0 ("No difficulty") to 4 ("Extreme difficulty"), with the total possible score for mWOMAC-PF ranging from 0 to 80. Participants with knee OA will complete the mWOMAC-PF.
Measured: Day 0, Day 7, Day 30, Day 60, and Day 90
To assess the effect of Native CT-II in comparison to baseline, GlucosamineHCL + Chondroitin Sulphate and placebo on acute knee joint pain assessedby change on 100 mm Visual Analogue Scale.
The pain VAS is a tool used to assess pain intensity. It consists of a 100 mm line with two endpoints representing the extremes of pain, such as "no pain" at one end and "extreme pain" at the other.40 It is reliable and valid measure for measuring acute pain.41 Participants will rate their pain by marking a point along the line that reflects their pain level.
Measured: Day 0, Day 7, Day30, Day 60 and 90
To assess the effect of Native CT-II in comparison to baseline, GlucosamineHCL + Chondroitin Sulphate and placebo on Knee pain and functions asassessed by change in knee Injury and Osteoarthritis Outcome Score.
The Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire is a self-administered tool designed to evaluate both short- and long-term outcomes relevant to individuals following a knee injury and pain. It measures five key domains: pain, symptoms, activities of daily living, sports and recreational function, and knee-related quality of life. The KOOS meets standard criteria for outcome measures, making it suitable for tracking the progression of knee injuries and the effectiveness of treatments.
Measured: Day 0, Day 7, Day30, Day 60 and 90
To assess the effect of Native CT-II in comparison to baseline, GlucosamineHCL + Chondroitin Sulphate and placebo on Average number of rescuemedication taken by participants in each group.
Rescue medication use will be evaluated by counting the number of tablets consumed against the number of tablets dispensed at each of the visits for each study. An average number of rescue medications taken by participants in each group will be recorded and will be compared across the groups
Measured: Day 0, Day 7, Day30, Day 60 and 90
To assess the effect of Native CT-II in comparison to baseline, GlucosamineHCL + Chondroitin Sulphate and placebo on Severity of osteoarthritis asassessed by change in Lequesne Functional Index test score.
Participants will self-administer the questionnaire via an e-diary on days 0, 7, 30, 60, and 90. They must avoid rescue medication and hot/cold fomentation for 48 hours before clinic visits. The knee with the highest pain score is designated as the index joint. Questions have graded options reflecting severity, with subscale scores ranging from 0 to 8, leading to a total LFI score between 0 and 24.48. A higher score indicates greater joint severity.
Measured: Day 0, Day 7, Day30, Day 60 and 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2025
- Study start20 Apr 2025
- Primary completion26 Mar 2026
- Study completion26 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee Osteoarthritis (OA)Studies 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
- Randomized, double-blind, placebo-controlled, parallel design
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vedic Lifesciences Pvt. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06917287
- Sponsor's protocol ID
- 241001/NCTII/OA
- Status last verified
- Sep 2026
- First submitted
- 1 Apr 2025
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Parallel Design Clinical Study to Evaluate the Efficacy of Native CT-II® in Individuals With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT06917287
- Acronym / sponsor ID
- 241001/NCTII/OA
- Conditions
- Knee Osteoarthritis (OA)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Vedic Lifesciences Pvt. Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Apr 2025 (actual)
- Primary completion
- 26 Mar 2026 (actual)
- Study completion
- 26 Mar 2026 (actual)
- First posted
- 8 Apr 2025 (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.
This randomized, double-blind, placebo-controlled clinical study evaluates the efficacy of Native CT-II® (undenatured type II collagen) in individuals with knee osteoarthritis using a parallel design.Participants are assigned to one of three groups:
Group 1 receives Native CT-II® (40 mg daily individed doses), Group 2 receives Glucosamine HCL + Chondroitin Sulphate (2700 mg daily as acomparator), and Group 3 receives a placebo (Microcrystalline Cellulose). All participants take threecapsules after breakfast and three after dinner for 90 days . The study aims to screen approximately 142 participants
, randomizing around 114 (considering a 20% dropout rate), with a target of 90completed participants (30 per group). Osteoarthritis (OA) is a degenerative joint disorder causing pain, stiffness, and reduced mobility,primarily affecting older adults. It is a leading cause of disability, with knee OA being the mostprevalent form. The global burden of OA is rising due to aging populations and increasing obesityrates, necessitating improved treatment options. Current management focuses on symptom reliefthrough non-pharmacological (exercise, weight loss) and pharmacological (NSAIDs, analgesics)interventions, though these can have adverse effects.
Undenatured type II collagen (NCTII), derived from chicken sternum, has emerged as a potentialsupplement for joint health. It triggers an immune response that reduces inflammation and supportscartilage repair. Clinical studies show that NCTII improves joint function, pain, and quality of life,outperforming glucosamine and chondroitin with fewer side effects. A new study aims to evaluatethe efficacy of Native CT-II® in individuals with Grade II and III knee OA over 90 days, comparing itto glucosamine-chondroitin and placebo groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- Randomized, double-blind, placebo-controlled, parallel design
| Arm | Type | Receives |
|---|---|---|
| Native CT-II® (undenatured type II collagen) | Experimental | Dietary Supplement: Native CT-II® (undenatured type II collagen)Strength: 40 mg in 3 capsules Dose Regimen: 3 yellow capsules containing MCC after breakfast with water 3 blue capsules containing 40 mg Native CT-II® \& MCC after dinner with water Route of administration: Oral |
| Glucosamine HCL + Chondroitin Sulphate (G+C) [Comparator] | Active comparator | Dietary Supplement: Glucosamine HCL + Chondroitin Sulphate (G+C) [Comparator]Strength: 2700 mg (1500 mg G + 1200 mg C) Dose Regimen: 3 yellow capsules containing G+C after breakfast with water 3 blue capsules containing G+C after dinner with water Route of administration: Oral |
| Placebo [Microcrystalline Cellulose (MCC)] | Placebo comparator | Dietary Supplement: Placebo [Microcrystalline Cellulose (MCC)Strength: 2700 mg excipient Dose Regimen: 3 yellow capsules containing MCC after breakfast with water 3 blue capsules containing MCC after dinner with water Route of administration: Oral |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 1.Individuals ready to give voluntary, written informed consent to participate in the study.
- 2.Males and females of age between 40 to 65 years (including both values) suffering from Knee Osteoarthritis under no medications.
- 3.Body mass index (BMI) between 18.5 to 29.9 kg/m2 (including both values). 4.mWOMAC total score ≥ 75. 5. Individuals with knee pain having VAS score of greater than or equal to 60 mm on a 100 mm VAS scale.
- 6.Radiographic evidence (lateral and anterio-posterior weight-bearing standing X-ray) of grade II/III (in 2: 1 ratio) knee Osteoarthritis (OA) for index joint (The knee with the higher pain score will be designated as the index joint for the study) based on the Kellgren and Lawrence (K\&L) radiographic entry criteria for OA -
- 7.Individuals with a history of symptomatic knee joint pain of at least 3 months.
Key exclusion criteria (11 listed)
- 1.Individuals who have been injured near the knee joint region in the past six months.
- 2.Individuals with a history of knee surgery, replacement or any non-knee surgical procedures that may impact the study outcomes.
- 3.Individuals who have used intra-articular injections, platelet replacement therapy, stem cell therapy and or steroids for joint health issues in the last six months.
- 4.Individuals who have any other chronic disease or condition, or inflammatory disease conditions and/ or are using any medication or dietary supplements or ayurvedic medications or topical ointment/oil/gel for joint health that in the judgment of the Investigator would put the individual at unacceptable risk for an individual in the study or may interfere with evaluations in the study or noncompliance with treatment or visits.
- 5.History or presence of clinically significant renal, hepatic, endocrine, biliary, gastrointestinal, pancreatic, or neurological disorders, that in the judgment of the Investigator, would interfere with the individual's ability to provide informed consent, comply with the study protocol (which might confound the interpretation of the study results), or put the individual at undue risk.
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 |
|---|---|---|
| Native CT-II® (undenatured type II collagen)Strength: 40 mg in 3 capsules Dose Regimen: 3 yellow capsules containing MCC after breakfast with water 3 blue capsules containing 40 mg Native CT-II® \& MCC after dinner with water Route of administration: Oral | Dietary supplement | Native CT-II® (undenatured type II collagen) |
| Glucosamine HCL + Chondroitin Sulphate (G+C) [Comparator]2700 mg (1500 mg G + 1200 mg C) 3 yellow capsules containing G+C orally after breakfast with water \& 3 blue capsules containing G+C after dinner with water | Dietary supplement | Glucosamine HCL + Chondroitin Sulphate (G+C) [Comparator] |
| Placebo [Microcrystalline Cellulose (MCC)2700 mg excipient 3 yellow capsules containing MCC orally after breakfast with water 3 blue capsules containing MCC after dinner with water. | Dietary supplement | Placebo [Microcrystalline Cellulose (MCC)] |
Primary outcome
To evaluate the effect of consumption of Native CT-II on knee joint health asassessed by change in modified Western Ontario and McMaster UniversityOsteoarthritis Index total score as compared to baseline,Glucosamine HCL + Chondroitin Sulphate an
Time frame: day 0, day 7, day 30, day 60 and day 90
The primary efficacy variable for this study is the total mWOMAC index score. The scores from each subscale will be combined, with the pain subscale ranging from 0 to 20, the stiffness subscale from 0 to 8, and the physical function subscale from 0 to 80. Participants with knee OA will complete the mWOMAC index total score.
7 secondary outcomes
To assess the effect of Native CT-II® in comparison to baseline, GlucosamineHCL + Chondroitin Sulphate and placebo on Knee joint pain as assessed bychange in mWOMAC - Pain subscale (mWOMAC-P) score.
Time frame: day 0, day 7, day 30, day 60 and day 90
To assess the effect of Native CT-II in comparison to baseline, GlucosamineHCL + Chondroitin Sulphate and placebo on Knee joint stiffness as assessedby change in mWOMAC - Stiffness subscale (mWOMAC-S) score.
Time frame: day 0, day 7, day 30, day 60 and day 90
To assess the effect of Native CT-II in comparison to baseline, GlucosamineHCL + Chondroitin Sulphate and placebo on Knee joint function as assessedby change in mWOMAC - Physical Function subscale (mWOMAC-PF) score.
Time frame: Day 0, Day 7, Day 30, Day 60, and Day 90
To assess the effect of Native CT-II in comparison to baseline, GlucosamineHCL + Chondroitin Sulphate and placebo on acute knee joint pain assessedby change on 100 mm Visual Analogue Scale.
Time frame: Day 0, Day 7, Day30, Day 60 and 90
To assess the effect of Native CT-II in comparison to baseline, GlucosamineHCL + Chondroitin Sulphate and placebo on Knee pain and functions asassessed by change in knee Injury and Osteoarthritis Outcome Score.
Time frame: Day 0, Day 7, Day30, Day 60 and 90
To assess the effect of Native CT-II in comparison to baseline, GlucosamineHCL + Chondroitin Sulphate and placebo on Average number of rescuemedication taken by participants in each group.
Time frame: Day 0, Day 7, Day30, Day 60 and 90
To assess the effect of Native CT-II in comparison to baseline, GlucosamineHCL + Chondroitin Sulphate and placebo on Severity of osteoarthritis asassessed by change in Lequesne Functional Index test score.
Time frame: Day 0, Day 7, Day30, Day 60 and 90
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 1 Oct 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Native CT-II® (undenatured type II collagen) and Glucosamine HCL + Chondroitin Sulphate (G+C) [Comparator] in people with Knee Osteoarthritis (OA), run by Vedic Lifesciences Pvt. Ltd. at 5 sites in India.
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 13 inclusion and 11 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 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in India. 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. Some participants in this study may receive a placebo. 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?
To evaluate the effect of consumption of Native CT-II on knee joint health asassessed by change in modified Western Ontario and McMaster UniversityOsteoarthritis Index total score as compared to baseline,Glucosamine HCL + Chondroitin Sulphate an (time frame: day 0, day 7, day 30, day 60 and day 90). 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 1 Oct 2026.