Osteoarthritis, KneeNCT05474586
To Evaluate the Efficacy and Safety of Collavant n2 in Individuals With Osteoarthritis of the Knee
A study testing Collavant n2 40 mg/day, Glucosamine hydrochloride & Chondroitin sulfate and Microcrystalline cellulose in people with Osteoarthritis, Knee, run by Vedic Lifesciences Pvt. Ltd. at 10 sites in India.
Trial summary
A randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of Collavant n2 in individuals with osteoarthritis of the knee. Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Collavant n2 40 mg/day, Glucosamine hydrochloride & Chondroitin sulfate and Microcrystalline cellulose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 236 participants
- Where
- 10 sitesIndia
- Study dates
- 8 Aug 2022to 4 Jul 2023
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and females ≥ 40 to ≤ 75 years suffering from knee joint pain for atleast 3 months before screening.
- Body mass index (BMI) ≥ 18.5 and ≤ 29.9 kg/m2
- Pain VAS for knee joint pain ≥ 5 and ≤ 7 cm on a 10 cm scale at screening.
- Radiographic evidence of grade II/III knee OA based on the Kellgren and Lawrence (KL) radiographic entry criteria for OA - i Grade II: Antero-posterior weight-bearing knee radiograph demonstrates possible joint space narrowing (JSN) with definite osteophyte formation.
- ii Grade III: Antero-posterior weight-bearing knee radiograph demonstrates definite joint space narrowing, multiple osteophyte formations, some sclerosis, and possible deformity of bony ends.
- LAI score of ≥ 6 - ≤10 at screening.
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- Willing to stop the restricted dietary supplements, home-based remedies, and any other form of topical products or medications 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.)
- Willing to stop using rescue medication 48 hours prior to all assessment visits.
- Using the western toilet at home and/or workplace.
- Willingness to participate and comply with the study procedures and required visits.
- Ability to understand and sign a written informed consent form, which must be completed before performing study-specific tasks.
- Literate and have the ability to complete the study-based questionnaires and tasks.
- Female participants of childbearing age must be willing to use the acceptable methods of contraception during the study.
Who cannot join
- 1 History of uncontrolled hypertension and/or systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg. 2 Fasting blood glucose (FBG) > 125 mg/dl. 3 Radiographic evidence of Grade I or Grade IV OA based on the KL radiographic criteria for osteoarthritis. 4 Any history of trauma, fractures, or surgery to the index joint. 5 Any planned surgery (diagnostic or therapeutic intervention) to the index joint during the participation in the study. 6 History of use of corticosteroid, disease modifying drugs, glucosamine, chondroitin, and intra-articular treatments including injections of corticosteroid or hyaluronic acid within 6 months of the screening visit and consumption of Omega-3 fatty acids or other joint health supplements within 15 days preceding the screening visit. 7 History of use of gabapentin within 6 weeks and/or methylcobalamin within 2 weeks prior to screening. 8 Known case of deformity of the knee joint or diagnosed on clinical examination during screening. 9 Known case of any joint disorder involving the index joint that includes but is not limited to known rheumatic or inflammatory conditions such as rheumatoid arthritis, osteomyelitis, osteoporosis, severe OA, and bone metastasis. 10 Known cases of gout and/or hyperuricemia (serum uric acid >440 μmol/L). 11 Other pathologic lesions on X-ray of the knee. 12 History of bleeding disorders (e.g., Haemophilia, Sickle cell anaemia, etc.).
- 13 Participants with abnormal levels of serum thyroid-stimulating hormone (TSH) (< 0.4 to > 4.2 mIU/L). 14 Any history or evidence of allergy to chicken, eggs, or protein products in the past. 15 Alcoholics or known drug dependents. (Alcoholism or heavy alcohol use is interpreted based on alcohol content consumed per day or week. It is defined as more than 4 drinks on any day or more than 14 drinks per week for men. For women, it is defined as more than 3 drinks on any day or more than 7 drinks per week. Standard alcoholic drink is roughly equivalent to 14 grams of pure alcohol, which is found in the following: i 12 ounces (Approx. 350 ml) of regular beer, which is usually about 5% alcohol ii 5 ounces (Approx. 150 ml) of wine, which is typically about 12% alcohol iii 1.5 ounces (Approx. 45 ml) of distilled spirits, which is about 40% alcohol) 16 History of smoking or currently smoking or using any form of smokeless tobacco. 17 Not willing to abstain from the use of NSAIDs (including low dose aspirin 50 mg/day for cardiovascular health). 18 Participation in a study of an investigational product within 90 days prior to the screening.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
India10 sites
Amber Clinic
Ahmedabad, Gujarat, 380015
Prme Orthopedic Speciality
Mumbai, Maharashtra, 400053
Diamond Hospital
Mumbai, Maharashtra, 400064
Ayush Nursing Home
Mumbai, Maharashtra, 400067
Life Care Hospital
Nashik, Maharashtra, 422009
Care n Cure Multispeciality Hospital
Pālghar, Maharashtra, 401209
Sparsh Hospital
Panvel, Maharashtra, 410206
Lifepoint Multispeciality Hospital
Pune, Maharashtra, 411057
Imperial Multispecialty Hospital
Pune, Maharashtra, 411062
Gayatri Hospital
Vasai, Maharashtra, 401208
About this study
Official title: A Randomised, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Collavant n2 in Individuals With Osteoarthritis of the Knee
A randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of Collavant n2 in individuals with osteoarthritis of the knee.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Collavant n2 40 mg/day, Glucosamine hydrochloride & Chondroitin sulfate, Microcrystalline cellulose
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collavant n2 40 mg/dayOther
2 capsules in the morning before breakfast and 2 capsules at night before going to bed for 180 days
Glucosamine hydrochloride & Chondroitin sulfateOther
2 capsules in the morning before breakfast and 2 capsules at night before going to bed for 180 days
Microcrystalline celluloseOther
2 capsules in the morning before breakfast and 2 capsules at night before going to bed for 180 days
| Study group | Role | What they receive |
|---|---|---|
| Collavant n2 40 mg/day | Experimental | 2 capsules in the morning before breakfast and 2 capsules at night before going to bed for 180 days Receives: Other: Collavant n2 40 mg/day |
| Glucosamine hydrochloride & Chondroitin sulfate | Active comparator | 2 capsules in the morning before breakfast and 2 capsules at night before going to bed for 180 days Receives: Other: Glucosamine hydrochloride & Chondroitin sulfate |
| Microcrystalline cellulose | Placebo comparator | 2 capsules in the morning before breakfast and 2 capsules at night before going to bed for 180 days Receives: Other: Microcrystalline cellulose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Western Ontario and McMaster Universities Osteoarthritis Index Pain subscale
Knee joint pain as assessed by the change in the Western Ontario and McMaster Universities Osteoarthritis Index Pain subscale (WOMAC-P) score.
the primary efficacy variable for the present study is the total WOMAC index score, the scores for each subscale will be summed up (Pain range: 0-20, Stiffness range: 0-8, and Physical function range: 0-68). Thus, the total WOMAC score will range from 0 - 96.
The lowest the score is the good response and highest the score is extreme pain i.e. bad response.
Measured: Day 0, 7, 30, 60, 90, 120, 150, and 180
Secondary outcomes (5)
Knee joint pain as assessed by the change in the Western Ontario and McMaster - Pain subscale score.
The first domain, WOMAC-P, comprises 5 questions evaluating the amount of pain due to OA in the index joint experienced by the participant. The WOMAC-P subscale score of 0 indicates 'No pain' and 4 indicates 'Extreme pain'.
Measured: Day 0, 7, 30, 60, 90, 120, 150, and 180
Knee joint stiffness as assessed by the change in the WOMAC - Stiffness subscale (WOMAC-S) score.
The domain, WOMAC-S, consists of 2 questions evaluating the amount of stiffness (resistance of the joint to movement characterized by difficulty in moving the joint along with pain and discomfort in the joint) experienced in the index joint. On the Likert scale, 0 indicates 'No stiffness' and 4 indicates 'Extreme stiffness'.
Measured: Day 0, 7, 30, 60, 90, 120, 150, and 180
Knee joint function as assessed by the change in the WOMAC - Physical function (WOMAC-PF) score.
The WOMAC-PF consists of 17 questions evaluating the degree of physical difficulty experienced in the index joint due to OA in the third domain. For WOMAC-PF, 0 indicates 'No difficulty' and 4 indicates 'Extreme difficulty'.
Measured: Day 0, 7, 30, 60, 90, 120, 150, and 180
Knee joint pain assessed by the change in the Visual Analogue Scale (VAS) score.
Point 0 indicates no pain and 10 indicates worst pain.
Measured: Day 0, 7, 30, 60, 90, 120, 150, and 180
Severity of osteoarthritis as assessed by the change in the Lequesne algofunctional index (LAI) score.
Higher scores indicate a worse joint condition and Lowest scores indicate agood joint condition
Measured: Day 0, 7, 30, 60, 90, 120, 150, and 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2022
- Study start8 Aug 2022
- Primary completion4 Jul 2023
- Study completion4 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies 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, Parallel Group, Placebo Controlled Trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 236 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vedic Lifesciences Pvt. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr Shalini Srivastava, MD medicine, Study director, Vedic Lifesciences Pvt. Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05474586
- Sponsor's protocol ID
- BI/210903/COLL/OA
- Status last verified
- Sep 2023
- First submitted
- 22 Jul 2022
- Last updated
- 6 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Collavant n2 in Individuals With Osteoarthritis of the Knee
- ClinicalTrials.gov ID
- NCT05474586
- Acronym / sponsor ID
- BI/210903/COLL/OA
- Conditions
- Osteoarthritis, Knee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 236 participants (actual)
- Lead sponsor
- Vedic Lifesciences Pvt. Ltd.Industry (pharma, biotech, devices)
- Study start
- 8 Aug 2022 (actual)
- Primary completion
- 4 Jul 2023 (actual)
- Study completion
- 4 Jul 2023 (actual)
- First posted
- 26 Jul 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.
A randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of Collavant n2 in individuals with osteoarthritis of the knee.
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, Parallel Group, Placebo Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Collavant n2 40 mg/day | Experimental | Other: Collavant n2 40 mg/day2 capsules in the morning before breakfast and 2 capsules at night before going to bed for 180 days |
| Glucosamine hydrochloride & Chondroitin sulfate | Active comparator | Other: Glucosamine hydrochloride & Chondroitin sulfate2 capsules in the morning before breakfast and 2 capsules at night before going to bed for 180 days |
| Microcrystalline cellulose | Placebo comparator | Other: Microcrystalline cellulose2 capsules in the morning before breakfast and 2 capsules at night before going to bed for 180 days |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Male and females ≥ 40 to ≤ 75 years suffering from knee joint pain for atleast 3 months before screening.
- Body mass index (BMI) ≥ 18.5 and ≤ 29.9 kg/m2
- Pain VAS for knee joint pain ≥ 5 and ≤ 7 cm on a 10 cm scale at screening.
- Radiographic evidence of grade II/III knee OA based on the Kellgren and Lawrence (KL) radiographic entry criteria for OA - i Grade II: Antero-posterior weight-bearing knee radiograph demonstrates possible joint space narrowing (JSN) with definite osteophyte formation.
- ii Grade III: Antero-posterior weight-bearing knee radiograph demonstrates definite joint space narrowing, multiple osteophyte formations, some sclerosis, and possible deformity of bony ends.
Key exclusion criteria (2 listed)
- 1 History of uncontrolled hypertension and/or systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg. 2 Fasting blood glucose (FBG) > 125 mg/dl. 3 Radiographic evidence of Grade I or Grade IV OA based on the KL radiographic criteria for osteoarthritis. 4 Any history of trauma, fractures, or surgery to the index joint. 5 Any planned surgery (diagnostic or therapeutic intervention) to the index joint during the participation in the study. 6 History of use of corticosteroid, disease modifying drugs, glucosamine, chondroitin, and intra-articular treatments including injections of corticosteroid or hyaluronic acid within 6 months of the screening visit and consumption of Omega-3 fatty acids or other joint health supplements within 15 days preceding the screening visit. 7 History of use of gabapentin within 6 weeks and/or methylcobalamin within 2 weeks prior to screening. 8 Known case of deformity of the knee joint or diagnosed on clinical examination during screening. 9 Known case of any joint disorder involving the index joint that includes but is not limited to known rheumatic or inflammatory conditions such as rheumatoid arthritis, osteomyelitis, osteoporosis, severe OA, and bone metastasis. 10 Known cases of gout and/or hyperuricemia (serum uric acid >440 μmol/L). 11 Other pathologic lesions on X-ray of the knee. 12 History of bleeding disorders (e.g., Haemophilia, Sickle cell anaemia, etc.).
- 13 Participants with abnormal levels of serum thyroid-stimulating hormone (TSH) (< 0.4 to > 4.2 mIU/L). 14 Any history or evidence of allergy to chicken, eggs, or protein products in the past. 15 Alcoholics or known drug dependents. (Alcoholism or heavy alcohol use is interpreted based on alcohol content consumed per day or week. It is defined as more than 4 drinks on any day or more than 14 drinks per week for men. For women, it is defined as more than 3 drinks on any day or more than 7 drinks per week. Standard alcoholic drink is roughly equivalent to 14 grams of pure alcohol, which is found in the following: i 12 ounces (Approx. 350 ml) of regular beer, which is usually about 5% alcohol ii 5 ounces (Approx. 150 ml) of wine, which is typically about 12% alcohol iii 1.5 ounces (Approx. 45 ml) of distilled spirits, which is about 40% alcohol) 16 History of smoking or currently smoking or using any form of smokeless tobacco. 17 Not willing to abstain from the use of NSAIDs (including low dose aspirin 50 mg/day for cardiovascular health). 18 Participation in a study of an investigational product within 90 days prior to the screening.
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 |
|---|---|---|
| Collavant n2 40 mg/day2 capsules in the morning before breakfast and 2 capsules at night before going to bed for 180 days | Other | Collavant n2 40 mg/day |
| Glucosamine hydrochloride & Chondroitin sulfate2 capsules in the morning before breakfast and 2 capsules at night before going to bed for 180 days | Other | Glucosamine hydrochloride & Chondroitin sulfate |
| Microcrystalline cellulose2 capsules in the morning before breakfast and 2 capsules at night before going to bed for 180 days | Other | Microcrystalline cellulose |
Primary outcome
Western Ontario and McMaster Universities Osteoarthritis Index Pain subscale
Time frame: Day 0, 7, 30, 60, 90, 120, 150, and 180
Knee joint pain as assessed by the change in the Western Ontario and McMaster Universities Osteoarthritis Index Pain subscale (WOMAC-P) score. the primary efficacy variable for the present study is the total WOMAC index score, the scores for each subscale will be summed up (Pain range: 0-20, Stiffness range: 0-8, and Physical function range: 0-68). Thus, the total WOMAC score will range from 0 - 96. The lowest the score is the good response and highest the score is extreme pain i.e. bad response.
5 secondary outcomes
Knee joint pain as assessed by the change in the Western Ontario and McMaster - Pain subscale score.
Time frame: Day 0, 7, 30, 60, 90, 120, 150, and 180
Knee joint stiffness as assessed by the change in the WOMAC - Stiffness subscale (WOMAC-S) score.
Time frame: Day 0, 7, 30, 60, 90, 120, 150, and 180
Knee joint function as assessed by the change in the WOMAC - Physical function (WOMAC-PF) score.
Time frame: Day 0, 7, 30, 60, 90, 120, 150, and 180
Knee joint pain assessed by the change in the Visual Analogue Scale (VAS) score.
Time frame: Day 0, 7, 30, 60, 90, 120, 150, and 180
Severity of osteoarthritis as assessed by the change in the Lequesne algofunctional index (LAI) score.
Time frame: Day 0, 7, 30, 60, 90, 120, 150, and 180
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 6 Sep 2023.
- Individual participant dataSharing planned: Undecided
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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.
Dr Shalini Srivastava, MD medicine study director
Vedic Lifesciences Pvt. Ltd.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Collavant n2 40 mg/day, Glucosamine hydrochloride & Chondroitin sulfate and Microcrystalline cellulose in people with Osteoarthritis, Knee, run by Vedic Lifesciences Pvt. Ltd. at 10 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 14 inclusion and 2 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 6 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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?
Western Ontario and McMaster Universities Osteoarthritis Index Pain subscale (time frame: Day 0, 7, 30, 60, 90, 120, 150, and 180). 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 6 Sep 2023.