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CTRI Number  CTRI/2023/05/052962 [Registered on: 19/05/2023] Trial Registered Prospectively
Last Modified On: 23/05/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Other 
Public Title of Study   A study to evaluate the effect of Boswellia Serrata in Osteoarthritis 
Scientific Title of Study
Modification(s)  		 To assess the efficacy and evaluate the anti-inflammatory effects of Boswellia serrata extract in Osteoarthritis 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Harish K 
Designation  Associate Professor 
Affiliation  Adichunchanagiri Hospital and Research Centre  
Address  Department of Orthopaedics Adichunchanagirir Hospital and Research Centre Adichunchanagiri University

Mandya
KARNATAKA
571448
India 
Phone  8971457844  
Fax    
Email  drharish66@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rajesh Venkataraman 
Designation  Professor and Head 
Affiliation  Adichunchanagiri Hospital and Research Centre  
Address  Department of Pharmacy Practice Room No:35 Adichunchanagiri Hospital and Research Centre B.G.Nagara Clinical Trial Centre Adichunchanagiri Hospital and Research Centre B.G.Nagara

Mandya
KARNATAKA
571448
India 
Phone  9980038331   
Fax    
Email  rajeshvenky_research@hotmail.com  
 
Details of Contact Person
Public Query  
Name  Dr C T SADASHIVA  
Designation  AGM R&D  
Affiliation  Star Hi Herbs Pvt Ltd  
Address  Star Hi Herbs Pvt Ltd Bangalore

Mandya
KARNATAKA
560105
India 
Phone  9342575028   
Fax    
Email  rndstarhiherbs@gmail.com  
 
Source of Monetary or Material Support  
Star Hi Herbs Pvt.Ltd No.50, 3rd Road, 1st Phase, KIADB, Ind Area, Jigani, Bangalore  
 
Primary Sponsor  
Name  Star Hi Herbs PvtLtd  
Address  No.50, 3rd Road, 1st Phase, KIADB, Ind Area, Jigani, Bangalore  
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Harish K  Adichunchanagiri Hospital and Research Centre   Department of Orthopaedics Adichunchanagiri Hospital and Research Centre
Mandya
KARNATAKA 		 9980038331

drharish66@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee of AH & RC, Adichunchanagiri Hospital & Research Centre   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M17||Osteoarthritis of knee,  
 
Intervention / Comparator Agent
Modification(s)  
Type  Name  Details 
Intervention  Boswellia serrata  Dose: 250 mg X 2 capsule Dosage form: Capsules Frequency: 2 capsules to be consumed orally at a time once daily after food Total dose: 500mg Duration:84 days or 3 months  
Comparator Agent  Placebo capsules   Dose: 250 mg X 2 capsule Dosage form: Capsules Frequency: 2 capsules to be consumed orally at a time once daily after food Total dose: 500mg Duration:84 days or 3 months 
 
Inclusion Criteria
Modification(s)  
Age From  40.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  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.
 
 
ExclusionCriteria 
Details  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.
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome
Modification(s)  
Outcome  TimePoints 
Reduce in the pain and stiffness and Physical Examination assessing via WOMAC , VAS, and LFI scores.  Visit 1 Screening (Day -3 to -1),
Visit 3 (Day 42 ±5),
Visit 4 (Day 84 ±5) 
 
Secondary Outcome
Modification(s)  
Outcome  TimePoints 
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
CRP, RA factor & X-rays
 		 Visit 1 Screening(Day -3 to -1),
Visit 3 (Day 42 ±5),
Visit 4 (Day 84 ±5) 
 
Target Sample Size
Modification(s)  		 Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   29/05/2023 
Date of Study Completion (India) 19/02/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
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.

 
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