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CTRI Number  CTRI/2022/11/047397 [Registered on: 17/11/2022] Trial Registered Prospectively
Last Modified On: 04/04/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Evaluate the effect of Boswellin® Super in the management of Osteoarthritis of knee. 
Scientific Title of Study   A double blind, randomized, three-arm, parallel group, multi-center, placebo-controlled trial to evaluate the safety and efficacy of Boswellin® Super in the management of Osteoarthritis of knee. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
CW/111/BSE_OSAR/II/AUG/22, Ver No: 1.0, Date: 01-Oct-22  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shaikh Nawazish Rabbani 
Designation  M.S (Orthopedists) 
Affiliation  NUHA Hospitals 
Address  NUHA Hospitals, No.12-19-61&62,Old bank Road, Kothapet, Guntur-522001, Andhra Pradesh, India.

Guntur
ANDHRA PRADESH
522001
India 
Phone  9985511327  
Fax    
Email  drnawazish@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Shaji Paulose 
Designation  General Manager 
Affiliation  Sami-Sabinsa Group Ltd 
Address  Sami-Sabinsa Group Ltd 19/1 & 19/2, I Main, II Phase, Peenya Industrial Area, Bengaluru, Karnataka 560058

Bangalore
KARNATAKA
560058
India 
Phone    
Fax    
Email  shaji@clinworld.net  
 
Details of Contact Person
Public Query  
Name  Shaji Paulose 
Designation  General Manager 
Affiliation  Sami-Sabinsa Group Ltd 
Address  Sami-Sabinsa Group Ltd 19/1 & 19/2, I Main, II Phase, Peenya Industrial Area, Bengaluru, Karnataka 560058

Bangalore
KARNATAKA
560058
India 
Phone    
Fax    
Email  shaji@clinworld.net  
 
Source of Monetary or Material Support  
Sami-Sabinsa Group Limited 19/1 & 19/2, I Main, II Phase, Peenya Industrial Area,Bangalore, Karnataka. 560058. 
 
Primary Sponsor  
Name  Sami Sabinsa Group Limited 
Address  Sami-Sabinsa Group Limited 19/1 & 19/2, I Main, II Phase, Peenya IndustrialArea, Bangalore, Karnataka. 560058. 
Type of Sponsor  Other [Manufactures and markets phytonutrients, standardized herbalextracts and nutritional supplements] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Neelanagowda V P Patil  K R Hospital   Department of Orthopedic, Mysore Medical college & Research Institute K R Hospital, Mysore
Mysore
KARNATAKA 		 9884701884

drneelanpatil@gmail.com 
Dr Shaikh Nawazish Rabbani  NUHA Hospitals  No.12-19-61&62, Old Bank Road,Kothapet, Guntur-522001, Andhra Pradesh, INDIA
Guntur
ANDHRA PRADESH 		 9985511327

drnawazish@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
Institutional Ethics Committeeof NUHA Hospitals  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M15-M19||Osteoarthritis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Boswellin® Super   150 mg (Boswellin Super 150mg + MCC 150mg) twice a day along with food for 90 Days 
Intervention  Boswellin® Super  300 mg (Boswellin Super 300mg) twice a day along with food for 90 days 
Comparator Agent  Placebo  300 mg (MCC 300mg) b.i.d along with food for 90 Days 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  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 – 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. 
 
ExclusionCriteria 
Details  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:
 Drug addiction
 Participants who have used the following substance within 1
week prior to screening – glucosamine sulfate, chondroitin
sulfate, NSAID, glucocorticoids, or steroids.
 Participant who has used hyaluronate within a month prior to
screening.
 Participants who have used the below dietary supplement
within the past 30 day – 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:
 Alcoholics (inability to control drinking due to both physical
and emotional dependence on alcohol characterized by
uncontrolled drinking and preoccupation with alcohol)
 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. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate the efficacy of Boswellin® Super in managing the painful
Osteoarthritis of Knee in study participants
Primary Endpoints:
1. Mean change in modified WOMAC – Total score (Day 0, Day 5, Day30, Day 60, and Day 90).
2. Mean change in VAS Pain Scale (Screening, day 5, day30, day 60 and
day 90) 		 1. Day 0, Day 5, Day30, Day 60, and Day 90.
2. Screening, day 5, day30, day 60 and day 90
 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the safety of Boswellin® Super along with other efficacy
parameters associated with OA in comparison to Placebo.
1. Safety assessment through change in vital sign, physical examination,adverse event.
2. Safety assessment through laboratory tests.
3. Mean change in modified WOMAC - pain subscale
4. Mean change in modified WOMAC - stiffness subscale
5. Mean change in modified WOMAC - function subscale
6. Mean change in Distance walked in 6 minutes
7. Mean Change in Lequesne Functional Index (LFI).
8. Mean change in European Q5D Quality of Life
9. Mean Change in Biomarker ( hs-CRP, ESR, TNF-alpha, and IL-6)
10. Mean change in physician’s global assessment. 		 1.Day 0, day 5, day 30, day 60, day 90 and day 105
2. Day 0, day 5, day 30, day
60 and day 90
3. Day 0, day 5, day 30,day 60 and day 90
4. Day 0, day 5,
day 30, day 60 and day 90
5. Day 0, day5,
day 30, day 60 and day 90
6. Day 0, day 5, day 30,
day 60 and day 90
7. Day 0, day 5, day 30, day 60 and day 90
8. Day 0, day 5, day 30,
day 60, day 90 and day 105
9. Day 0 and day 90
10. Screening, Day 5, day
30, day 60 and day 90  
 
Target Sample Size   Total Sample Size="105"
Sample Size from India="105" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   01/12/2022 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details
Modification(s)  		 NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  
1] After obtaining consent from the participant, all the screening tests will be performed.
2] Male and female participants who meet all the Inclusion and none of the Exclusion criteria will be enrolled in the study.
3] Enrolled participants will be randomized on baseline visit and will be administered and advised to take either extract containing Boswellin® Super
150 mg b.i.d. or Boswellin® Super 300 mg b.i.d. or Placebo 300 mg b.i.d for a period of 90 days.
4] Participants will have to visit the study site on Screening (Day -5), baseline visit (Day 0), Visit 3 (Day 5), Visit 4 (Day 30), Visit 5 (Day 60)
and Visit 6 (Day 90). Telephonic follow-up after 15 days from the last visit.
5] Primary and secondary efficacy endpoints such as modified WOMAC, VAS Pain Scale, Six Minute Walk Test, European Q5D QOL, Lequesne
Functional Index, KL Grade to be assessed based on X-ray of the knee (Anterior Posterior view), biomarkers, Physician Global Assessment and
Safety Assessment would be carried out as per the protocol timepoints.
6] If the pain persist, participants are allowed to take Celecoxib 200mg orally a day as a rescue medication as and when required.
7] Residual efficacy will be evaluated on day 105 i.e. 15 days after the treatment period by asking the participant about his/ her perception of pain
from day 90.
 
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