Clinical trial NCT05474586: To Evaluate the Efficacy and Safety of Collavant n2 in Individuals With Osteoarthritis of the Knee
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Knee
Lead sponsor: Vedic Lifesciences Pvt. Ltd.
Sponsor class: INDUSTRY
First posted: 2022-07-26
Enrollment: 236
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, Parallel Group, Placebo Controlled Trial
Primary purpose: TREATMENT

Brief summary: A randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of Collavant n2 in individuals with osteoarthritis of the knee.


Eligibility criteria: 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. 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.

Primary outcomes:
measure: Western Ontario and McMaster Universities Osteoarthritis Index Pain subscale
timeFrame: Day 0, 7, 30, 60, 90, 120, 150, and 180
Secondary outcomes:
measure: Knee joint pain as assessed by the change in the Western Ontario and McMaster - Pain subscale score.
timeFrame: Day 0, 7, 30, 60, 90, 120, 150, and 180
measure: Knee joint stiffness as assessed by the change in the WOMAC - Stiffness subscale (WOMAC-S) score.
timeFrame: Day 0, 7, 30, 60, 90, 120, 150, and 180
measure: Knee joint function as assessed by the change in the WOMAC - Physical function (WOMAC-PF) score.
timeFrame: Day 0, 7, 30, 60, 90, 120, 150, and 180
measure: Knee joint pain assessed by the change in the Visual Analogue Scale (VAS) score.
timeFrame: Day 0, 7, 30, 60, 90, 120, 150, and 180
measure: Severity of osteoarthritis as assessed by the change in the Lequesne algofunctional index (LAI) score.
timeFrame: Day 0, 7, 30, 60, 90, 120, 150, and 180
Other outcomes:
Locations:
city: Ahmedabad
country: India
facility: Amber Clinic
state: Gujarat
city: Mumbai
country: India
facility: Prme Orthopedic Speciality
state: Maharashtra
city: Mumbai
country: India
facility: Diamond Hospital
state: Maharashtra
city: Mumbai
country: India
facility: Ayush Nursing Home
state: Maharashtra
city: Nashik
country: India
facility: Life Care Hospital
state: Maharashtra
city: Palghar
country: India
facility: Care n Cure Multispeciality Hospital
state: Maharashtra
city: Panvel
country: India
facility: Sparsh Hospital
state: Maharashtra
city: Pune
country: India
facility: Lifepoint Multispeciality Hospital
state: Maharashtra
city: Pune
country: India
facility: Imperial Multispecialty Hospital
state: Maharashtra
city: Vasai
country: India
facility: Gayatri Hospital
state: Maharashtra
Study officials:
affiliation: Vedic Lifesciences Pvt. Ltd.
name: Dr Shalini Srivastava, MD medicine
role: STUDY_DIRECTOR
References: