To assess the efficacy and evaluate the anti-inflammatory effects of Boswellia serrata extract in Osteoarthritis
Trial Snapshot
- Phase
- Phase 2/3
- Status
- Completed
- Sponsor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Reduce in the pain and stiffness and Physical Examination assessing via WOMAC , VAS, and LFI scores.
Study Overview
Brief Summary
Osteoarthritis (OA) is a common, multifactorial, degenerative joint condition characterized by functional impairment and persistent pain . It is the third fastest-growing condition associated with disability, and its prevalence rises with age and obesity . 528 million people worldwide have OA, and 19 million of them have lived with a disability. There are about 15 million new cases reported each year. Up until now, OA has been considered incurable, and the preferred medications for symptomatic treatment and preventing progression tend to be NSAIDs and steroids, both of which have a high incidence of adverse events (AE). Reduced levels of physical activity, comorbid conditions (as OA increases the risk of developing heart disease by 50%), and NSAIDs induced AE led to a 55% increase in all-cause mortality. This is the right time to find out the safer alternative to treating OA. Boswellia serrata, also known as salai or salai guggul, is a medium- to large-sized branching tree that grows in dry mountainous areas of India, Northern Africa, and the Middle East. It belongs to the family Burseraceae and is part of the genus Boswellia . It contains monoterpenes (α-thujene); diterpenes (macrocyclic diterpenoids such as incensole, incensole oxide, iso-incensole oxide, a diterpene alcohol [serratol]); triterpenes (such as α- and β- amyrins); pentacyclic triterpenic acids (boswellic acids); tetracyclic triterpenic acids (tirucall- 8,24-dien-21-oic acids). Hence, the present study is planned to assess boswella serreta’s effectiveness as an antiinflammatory in the treatment of OA.
Study Design
- Study Type
- Interventional
- Allocation
- Other
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 40.00 Year(s) to 75.00 Year(s) (—)
- Sex
- All
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 selfâ€care activities 7.Current or recent (in the last 3 months) oral or intraâ€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.
Outcomes
Primary Outcomes
Reduce in the pain and stiffness and Physical Examination assessing via WOMAC , VAS, and LFI scores.
Time Frame: Visit 1 Screening (Day -3 to -1), | Visit 3 (Day 42 ±5), | Visit 4 (Day 84 ±5)
Secondary Outcomes
- Reduce in the level’s inflammatory markers (CRP, IL-6, & serum Leukotriene B4, MM P-3).(CBC with ESR,Lipid Profile, Fasting blood sugar, Serum HBsAg, LFT, RFT)