Study to evaluate the efficacy and safety of Collavant n2 in individuals with osteoarthritis of the knee

Completed

• Conditions: Bilateral primary osteoarthritis of knee,

• Registration Number: CTRI/2022/08/044624
• Lead Sponsor: Vedic Lifesciences Pvt Ltd

Brief Summary

This study is a randomized, double-blind study to evaluate efficacy and safety of the investigational product in individuals with grade II or grade III osteoarthritis of the knee. The study has three arms; investigational product arm, glucosamine hydrochloride + Chondroitin sulfate arm and placebo arm. 255 participants will be randomized into the 3 arms of the study.

The Investigational product is Collavant n2, which consists of type II native collagen. The main aim of this study is to assess the effect of Collavant n2 on various aspects of joint health as compared to placebo and glucosamine arm

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-08
• Study Completion: 2023-04-07
• Last Update Posted: 2023-07-09

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 255

Inclusion Criteria

• 1. Male and females ≥ 40 to ≤ 75 years suffering from knee joint pain for atleast 3 months before screening. 2. Body mass index (BMI) ≥ 18.5 and ≤ 29.9 kg/m2 3. Pain VAS for knee joint pain ≥ 5 and ≤ 7 cm on a 10 cm scale at screening. 4. 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. 5. LAI score of ≥ 6.
• ≤10 at screening. 6. 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.) 7. Willing to stop using rescue medication 48 hours prior to all assessment visits. 8. Using the western toilet at home and/or workplace. 9. Willingness to participate and comply with the study procedures and required visits. 10. Ability to understand and sign a written informed consent form, which must be completed before performing study-specific tasks. 11. Literate and have the ability to complete the study-based questionnaires and tasks. 12. Female participants of childbearing age must be willing to use the acceptable methods of contraception during the study.

Exclusion Criteria

• 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.
• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the effect of 6-month (180 days) consumption of Collavant n2 on	Day 0 and 180
knee joint health as assessed by change in Western Ontario and McMaster	Day 0 and 180
University Osteoarthritis Index (WOMAC) total score compared to placebo.	Day 0 and 180

Secondary Outcome Measures

Name	Time	Method
Knee joint pain as assessed by the change in the WOMAC - Pain subscale	(WOMAC-P) score.
Knee joint pain assessed by the change in the Visual Analogue Scale (VAS)	score.
Overall health of the participant as assessed by change in the Participant’s	Global Assessment of Osteoarthritis (PGA-OA)
Percentage of responders as per OMERACT-OARSI responder index.	Day 180
Knee joint stiffness as assessed by the change in the WOMAC - Stiffness	subscale (WOMAC-S) score.
Knee joint function as assessed by the change in the WOMAC - Physical	function (WOMAC-PF) score.
Cartilage metabolism determined by urine levels of C-terminal cross-linked	telopeptide of type II collagen (CTX-II).
Use of rescue medication.	Day 7, 30, 60, 90, 120, 150, and 180
Severity of osteoarthritis as assessed by the change in the Lequesne	algofunctional index (LAI) score.
Knee joint health as assessed by the change in total WOMAC score	Day 0, 7, 30, 60, 90, 120, 150, and 180

Trial Locations

Locations (11)

Amber Clinic; 🇮🇳 Ahmadabad, GUJARAT, India

Ayush Nursing Home; 🇮🇳 (Suburban), MAHARASHTRA, India

Care n Cure Multispeciality Hospital; 🇮🇳 Thane, MAHARASHTRA, India

Diamond Hospital; 🇮🇳 (Suburban), MAHARASHTRA, India

Ganga Superspeciality Hospital; 🇮🇳 Nashik, MAHARASHTRA, India

Gayatri Hospital,; 🇮🇳 Mumbai, MAHARASHTRA, India

Imperial Multispeciality Hospital; 🇮🇳 Pune, MAHARASHTRA, India

Life Care Hospital; 🇮🇳 Nashik, MAHARASHTRA, India

Lifepoint Multispeciality Hospital; 🇮🇳 Pune, MAHARASHTRA, India

Prime Speciality Hospital; 🇮🇳 (Suburban), MAHARASHTRA, India

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Amber Clinic

🇮🇳Ahmadabad, GUJARAT, India

Dr Nikunj Dadhaniya

Principal investigator

9712999726

nikunjvdadhaniya@gmail.com