Efficacy and safety of KAL-13 in Osteoarthritis

Phase 2

Completed

• Conditions: Health Condition 1: null- Osteoarthritis of Knee and/or HipHealth Condition 2: M179- Osteoarthritis of knee, unspecified

• Registration Number: CTRI/2017/12/010899
• Lead Sponsor: Kerala Ayurveda Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2014-04-30
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 150

Inclusion Criteria

1. History of osteoarthritis of the knee characterized by pain of mild or moderate intensity.

2. Presence of persistent knee pain for at least 1 preceding month preceding the study.

3. Require treatment with either analgesic or anti-inflammatory agent on a regular basis (greater than or equal to three days/week) for at least three months.

4. Diagnosis of osteoarthritis of the hip or knee

5. Diagnosis of hip OA: having hip pain and meeting criteria for at least 2 of the following:

5a) Westergren erythrocyte sedimentation rate of less than 20 mm/hr

5b)Radiographic femoral or acetabular osteophytes or

5c)Radiographic joint space narrowing

6. Diagnosis of knee OA: Diagnosing (by modified American College of Rheumatology criteria) OA of the knee with pain plus with at least one of the following:

6a)Age greater than 50 years

6b)Stiffness less than 30 minutes

6c)Crepitus on active motion and radiographic evidence of OA of the knee, defined as presence of osteophytes or joint space narrowing.

7. Symptomatic OA of the knee or hip was determined at the Baseline visit, if the patientââ?¬•s assessment of arthritis pain was at least 40 mm VAS, patientââ?¬•s and the physicianââ?¬•s global assessment of arthritis was ââ?¬Å?poorââ?¬? or

ââ?¬Å?very poorââ?¬?

8. Have a mini mental state examination score of greater than or equal to 26 at screening

9. Medically stable condition

10. Ability to comply with the requirements of the study and to give informed consent

11. Subjects must be willing and able to stop all current pain therapy for the duration of study. (SOS pain therapy will be available throughout the study)

Exclusion Criteria

1. History of surgery , including arthroscopy, or major trauma to the study joint in the previous 12 months.

2. Radiographic evidence of severe osteoarthritis of the study joint based on the kellergen and Lawrence radiographic criteria of grade 4 osteoarthritis

3. Signs of active study joint inflammation including redness, warmth, and/or if qualifying with osteoarthritis of knee, a large, bulging effusion of the study knee joint with the loss of normal contour of the joint at the screening visit or at the baseline examination after the washout period.

4. Morning stiffness of >30 minutes duration.

5. Significantly incapacitated or disabled and would be categorized as ACR functional class III (able to perform only few or none of the duties of usual occupation or self-care) or IV (largely or wholly incapacitated) or unable to walk without assistive devices

6. History of Joint replacement surgery in the affected joint or planned surgery involving the affected joint during the trial.

7. Significant renal impairment ( > 1.5 times the upper limit of normal (ULN) of serum creatinine)

8. Active hepatic disease

9. Acute meniscal injury to the study joint within 2 years of study entry, arthroscopy in the study joint within 6 months of the study entry

10. Weight in excess of 280 pounds (120 kg)

11. Positive pregnancy test

12. Women of childbearing age who are willing to take adequate contraceptive precautions unless abstinence can be consider in the investigators opinion

13. Pregnant or lactating women or women intending to become pregnant

14. Patients awaiting a knee or hip joint replacement

15. Patients with other conditions that cause pain

16. Patients with congenital dislocation of the hip

17. Patients who have had operations on their hip due to previous trauma

18. Patients with other known rheumatic disease such as rheumatoid arthritis

19. Patients with the diagnosis gout

20. Patients who report a red or hot swollen joint and require further rheumatological assessment

21. Patients administered with intra-articular steroids for joints within 3 months prior to the study entry

22. History of allergy or contraindications to the ingredients present in the drug

23. History of uncontrolled or poorly controlled serum cholesterol

24. Renal impairment/insufficiency (i.e., nephritis, polycystic kidney disease, acute or chronic renal failure, end-stage renal disease, >1.5 times the upper limit of normal (ULN) of serum creatinine, etc.,)AST, ALT >3 times the ULN

25. Gastrointestinal disorders

26. Thyroid dysfunction

27. Hepatic impairment/ acute liver disease or persistent elevations in liver function tests (3 times the upper limit of normal (ULN) of LFT

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction in signs and symptoms of osteoarthritis <br/ ><br>Change from baseline in the western Ontario and McMaster Universities (WOMAC) 3.1 osteoarthritis Index composite, pain, Morning stiffness and physical function subscale scoresTimepoint: Visit 1: Day -7 (Screening) <br/ ><br>Visit 2: Day 1 (Baseline) <br/ ><br>Visit 3: Day 30 (Data Collection) <br/ ><br>Visit 4: Day 60 (Data Collection) <br/ ><br>Visit 5 Day 90 (Data Collection) <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
Kellgren and Lawrence scoring/ assessment of osteoarthritisTimepoint: Visit 1: Day -7 (Screening) <br/ ><br>Visit 2: Day 1 (Baseline) <br/ ><br>Visit 5 Day 90 (Data Collection) <br/ ><br>