Evaluate the effect of Boswellin® Super in the management of Osteoarthritis of knee.

Phase 3

Recruiting

• Conditions: Health Condition 1: M15-M19- Osteoarthritis

• Registration Number: CTRI/2022/11/047397
• Lead Sponsor: Sami Sabinsa Group Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 1 May 2023

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Participants of either sex, 40 to 75 years of age.

2. Participants newly diagnosed with degenerative hypertrophy OA

(imaging diagnosis)

3. Participants whose knee KL (Kellgren-Lawrence) grade is I-II.

4. Participant with the pain perception ranging from 30 to 100 when

measuring VAS (Visual Analog Scale) of 0 â?? 100mm.

5. Willing to come for regular follow -up visits.

6. Able to give written informed consent and comply with the

requirements of the trial.

Exclusion Criteria

1. Known history of hypersensitivity to herbal extracts or dietary

supplements.

2. Pregnant women, lactating women and women of childbearing

potential not following adequate contraceptive measure, 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. Participant with moderate or severe synovitis: KL (Kellgren-Lawrence)

grade III or higher.

5. Participants incapacitated or bound to wheelchair or bed and unable to

carry out self-care activities.

6. Participant with a history of knee or hip replacement surgery.

7. Treatment with intra-articular injection of corticosteroids into the knee

within 3 months preceding study.

8. Pre-existing or recent onset of demyelinating disorders.

9. Participants with a ruptured meniscus.

10. Evidence of several renal, hepatic, or hemopoietic diseases or severe

cardiac insufficiency as revealed by laboratory investigations.

11. Participant with chronic diseases of kidney, liver, or gastrointestinal

tract, cardiovascular, endocrine, or nervous system.

12. Participants with uncontrolled hypertension and uncontrolled diabetes.

13. Clinically significant untreated hyperlipidaemia in context of a

cardiovascular risk.

14. Medication:

ï?· Drug addiction

ï?· Participants who have used the following substance within 1

week prior to screening â?? glucosamine sulfate, chondroitin

sulfate, NSAID, glucocorticoids, or steroids.

ï?· Participant who has used hyaluronate within a month prior to

screening.

ï?· Participants who have used the below dietary supplement

within the past 30 day â?? Boswellia, Omega3, Collagen,

Curcumin etc.

15. History of having received any investigational drug or participated in

any other clinical trial which ended in preceding month or currently

ongoing.

16. Lifestyle:

ï?· Alcoholics (inability to control drinking due to both physical

and emotional dependence on alcohol characterized by

uncontrolled drinking and preoccupation with alcohol)

ï?· History of chronic smoking (more than 2 cigarettes a day)

17. Ayurvedic formulation or any form of CAM (Complimentary

Alternative Medicine) therapy in the preceding 2 months.

Study & Design

• Study Type: Interventional
• Study Design: Not specified