A clinical trial of herbal products in the management of knee osteoarthritis

Phase 3

Not yet recruiting

• Conditions: Health Condition 1: M179- Osteoarthritis of knee, unspecified

• Registration Number: CTRI/2023/07/054799
• Lead Sponsor: Phytoveda Pvt. Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 16 October 2023

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1.Patients of either sex with age 40 to 65 years (both inclusive) with a BMI not more than 30.00 kg/m2;2.Confirmed diagnosis of knee osteoarthritis as per clinical American College of Rheumatology (ACR) criteria – Clinical OA of the knee is defined as knee pain and at least three out of six of the following criteria: age >50 years, morning stiffness <30 min, crepitus, bony tenderness, bony enlargement, and no palpable warmth; 3.Patients with a minimum pain visual analog scale (VAS) score > 4 on walking in one or both knees during the 24 hrs. preceding recruitment;

4.Patient ambulant and requiring treatment with an anti ?inflammatory drug and not receiving regular anti ?inflammatory or analgesic drugs or not satisfied with drugs being taken and seek a change;5.Patients taking analgesics ready for the washout period of at least 3 days (or longer depending on the pharmacokinetic of drug) before starting the study intervention. 6.Patients willing to come for regular follow ?up visits;

7.Participants can walk and give both verbal and written information regarding the study.

Exclusion Criteria

1.Known history of hypersensitivity to herbal extracts or dietary supplements;

2.Pregnant women, lactating women, women of child bearing potential not following adequate contraceptive measures, women who were found positive for urine pregnancy test;

3.Non-degenerative joint diseases or other joint degenerative diseases (musculoskeletal disorders) which will interfere with the evaluation of OA (Rheumatoid arthritis, active gout, recent joint trauma (target joint), or joint infection);

4.Patients incapacitated or bound to a wheelchair or bed and unable to carry out self-care activities;

5.Ongoing treatment with anticoagulants, hydantoin, lithium, steroids, methotrexate, and colchicine;

6.Evidence of several renal, hepatic, or hematopoietic diseases or severe cardiac insufficiency as revealed by laboratory investigations;

7.Patient with congestive heart failure;

8.Ayurvedic formulation or any form of CAM (Complimentary Alternative Medicine) therapy in the preceding 3 months;

9.Administration of intra-articular steroids in the past 3 months or hyaluronic acid in the last 9 months;

10.Indication of surgery for OA knee;

11.Arthroscopy of either knee in the past year;

12.Any condition that in the opinion of the investigator does not justify the patient’s inclusion in the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Changes in WOMAC A, B, & C subscale scores for pain, stiffness, & physical disability at screening, day 7, day 15, day 30, day 45, day 60, & day 90. <br/ ><br>-WOMAC-A is assessed by a Likert scale on a range from 0 (none) to 4 (extreme), with higher scores indicating higher levels of pain, <br/ ><br>-WOMAC- B for levels of stiffness & <br/ ><br>-WOMAC-C for levels of physical disability <br/ ><br>2.Changes in physician’s global assessment for pain at screening, day 1, day 3, day 7, day 15, day 30, day 45, day 60, & day 90. <br/ ><br>3.Changes in distance covered in the six ?minute walk test at day 0, day 7, day 15, day 30, day 45, day 60, & day 90 <br/ ><br>4.Changes in VAS pain scale score at screening, day 1, day 3, day 7, day 15,day 30, day 45, day 60, day 90, day 105 and day 120 <br/ ><br>5.Changes in radiological examination (X-ray) only for patients as per the discretion of the investigator – day 0 and day 90Timepoint: From screening Visit to end of the study.

Secondary Outcome Measures

Name	Time	Method
1.Changes in biomarkers such as PIIANP, Human Procollagen 2 C-terminal Peptide, Cartilage Oligomeric Matrix Protein, C-Telopeptide of type II collagen (CTX-II), TNF-Alpha, IL-1, IL-6, IL-7, hsCRP, MMPs (MMP 3) at screening & day 90. <br/ ><br>2.Changes in requirement of analgesic as a rescue medication at screening, day 30, day 60, & day 90. <br/ ><br>3.Changes in gastrointestinal symptoms like heartburn, gastric discomfort, & epigastric pain on the 4-point Linkert scale at screening, day 7, day 15, day 30, day 45, day 60, and day 90. <br/ ><br>4.Changes in KOOS scoring for quality of life at day 0 and day 90. <br/ ><br>5.Changes in FACIT-F score at day 0 and day 90. <br/ ><br>6.Changes in symptom grading on a 4-point Linkert scale for joint swelling, tenderness, and warmth at screening, day 1, day 3, day 7, day 15, day 30, day 45, day 60, and day 90.Timepoint: From screening Visit to end of the study.