A study to evaluate the effect of Boswellia Serrata in Osteoarthritis

Phase 2

Completed

• Conditions: Health Condition 1: M17- Osteoarthritis of knee

• Registration Number: CTRI/2023/05/052962
• Lead Sponsor: Star Hi Herbs PvtLtd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2024-02-19
• Last Update Posted: 27 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 100

Inclusion Criteria

1.Participants between 40 to 75 years

2.Suffering from unilateral or bilateral OA of the knee within grade-2 according to the Kellgren-Lawrence Classification of Osteoarthritis

3.Patients with a minimum pain visual analogue scale (VAS) score 3.5 to 7.4

4.Lequesnes functional index between 5-7 points

5.The Western Ontario McMaster Index (WOMAC) score should be less than or equal to 48

6.Participants have to be able to walk and give both verbal and written information regarding the study

7.Subjects willing to comply with the prescribed treatment regime for the duration of study participation.

Exclusion Criteria

1.Expectations for surgery in the near future

2.Patients who are on medication for OA.

3.Known hypersensitivity to herbal extracts or dietary supplements

4.Pregnant or lactating women and women of child bearing potential not following adequate contraceptive measure or women who were found positive for urine pregnancy test

5.Non degenerative joint diseases or other joint degenerative diseases

6.Incapacitated or bound to a wheelchair or bed and unable to carry out self ?care activities

7.Current or recent (in the last 3 months) oral or intra ?articular corticosteroid therapy

8.Pre-existing or recent onset of demyelinating disorders or type I diabetes

9.Ongoing with anticoagulants, hydantoin, lithium, steroids, methotrexate, and colchicine

10.Renal, hepatic, hematopoietic disease, hypertension, severe cardiac insufficiency, congestive heart failure and untreated hyperlipidemia (cardiovascular risk)

11.Ayurvedic formulation or any form of complementary alternative medicine therapy in the preceding 2 months

12.Receiving any investigational drug or participating in any other clinical trial that ended in preceding month or currently ongoing

13.Patients who needed high dose of NSAIDs or analgesics; and

14.Inability to comply with study procedures.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduce in the pain and stiffness and Physical Examination assessing via WOMAC , VAS, and LFI scores.Timepoint: Visit 1 Screening (Day -3 to -1), <br/ ><br>Visit 3 (Day 42 ±5), <br/ ><br>Visit 4 (Day 84 ±5)

Secondary Outcome Measures

Name	Time	Method
Reduce in the level’s inflammatory markers (CRP, IL-6, & serum Leukotriene B4, MM P-3). <br/ ><br> <br/ ><br>CBC with ESR,Lipid Profile, Fasting blood sugar, Serum HBsAg, LFT, RFT <br/ ><br>CRP, RA factor & X-rays <br/ ><br>Timepoint: Visit 1 Screening(Day -3 to -1), <br/ ><br>Visit 3 (Day 42 ±5), <br/ ><br>Visit 4 (Day 84 ±5)