Clinical study of Arthrohills Capsules Arthritis patients

Phase 2

Completed

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

• Registration Number: CTRI/2017/06/008786
• Lead Sponsor: Herbal Hills Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2017-04-07
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 33

Inclusion Criteria

1. Symptoms of osteoarthritis in one or both knee joints for a minimum of six months and maximum for five years

2. History of knee pain due to osteoarthritis requiring the use of NSAIDs, Acetaminophen, or another analgesic agent on a regular basis i.e. greater than or equal to three days per week for at least six months before the screening visit

3. OA confirmed by radiographs and diagnosed according to ACR diagnostic Criteria

4. Subjects with pain VAS greater than or equal to 40 mm on weight bearing activities

Exclusion Criteria

1. Rheumatoid arthritis, gout, pseudo gout, inflammatory arthritis, Pagets disease of bone, chronic pain syndrome, fibromyalgia, or another major joint disease

2. History of surgery, including arthroscopy, or major trauma to the study joint in the previous six months before the screening visit

3. Subjects requiring knee arthroplasty within 6 months of screening or anticipating any need for a surgical procedure on the index joint during the study

4. Use of systemic corticosteroids within 2 months of screening, or intra-articular visco supplementation within the past 3 months

5. Subjects having diabetes mellitus, tuberculosis, HIV, Ischemic Heart Disease

6. Known other major medical or surgical disease

7. Pregnancy and Lactation.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Assessment of Knee Joint Pain on VAS <br/ ><br>2.Assessment of WOMAC Index <br/ ><br> <br/ ><br>Timepoint: Day -7, Day 0, Day 15, Day 30, Day 45, Day 60, Day 75, Day 90 <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
1) Quality of life on Karnofsky and Lansky Performance Score <br/ ><br>2)Time to walk 50 feet and distance between feet while walking 50 feet on even surface. <br/ ><br>3)Global assessment for overall improvement by the subject and Investigator at the end of study treatment. <br/ ><br>4)Assessment of use of NSAIDs as rescue medicine <br/ ><br>5)Tolerability of the study drug <br/ ><br>6) Safety laboratory parametersTimepoint: Day -7, Day 0, Day 15, Day 30, Day 45, Day 60, Day 75, Day 90