MedPath

se of Amrutanjan Advanced Ortho Pain Relief + Oil in arthritis patients

Phase 3
Conditions
Health Condition 1: M179- Osteoarthritis of knee, unspecified
Registration Number
CTRI/2024/04/065669
Lead Sponsor
Amrutanjan Health Care Limited, Tamil Nadu, India
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

1. Have osteoarthritis (OA) of the knee joint based on American College of Rheumatology

(ACR) criteria and confirmed with X-rays and with grade I and II as per Kellgren and

Lawrence classification system and patients previously diagnosed with Rheumatoid

arthritis (grade I and II) as per the American Rheumatism Association.

2. Have been on stable dose of Nonsteroidal Anti-Inflammatory Drugs (NSAIDS) and

other treatments for a minimum period of 3 months in the past.

3. Pain defined by a level of greater than or equal to 30 mm on a 100 mm Visual Analogue

Scale (VAS)

4. Patient should have not participated in any other clinical trial during the past 3 months.

5. Participants, who are willing to give written, signed and dated informed consent to

participate in the study.

Exclusion Criteria

1. Recent history of trauma to the knee joint.

2. Having severe pain and inflammation, which is not getting controlled on NSAIDs

3. Uncontrolled diabetic patients with Hba1C greater than 10.

4. Pregnant or lactating

5. Received any other investigational medicine within 7 days prior to screening which

can interfere with investigational product activity

6. Suffering from any illness which will interfere with present study as decided by

clinical investigator

7. History of hypersensitivity to any of the test products.

8. Any condition (like instability of knee joint, ligament tear or loose bodies in knee

joint) decided as unfit for study by Clinical investigator

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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