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CTRI Number  CTRI/2023/07/055345 [Registered on: 19/07/2023] Trial Registered Prospectively
Last Modified On: 09/02/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A clinical study to evaluate the efficacy, safety and tolerability of XtraBosTM (Boswellia Serrata Extract) in patients with osteoarthritis associated with hypertension or neuropathic pain, or sleep disorder. 
Scientific Title of Study   A Randomized, Double-Blind Study Evaluating the Efficacy, Safety and Tolerability of XtraBosTM (Boswellia Serrata Extract) Compared with Placebo in participants with Osteoarthritis Associated with Hypertension or Neuropathic Pain, or Sleep Disorder. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
EP-R202-241122-OA-SI-V01  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Kuldeep Katariya 
Designation  Consultant MD 
Affiliation  Jeevandan Multicare Hospital, Bhopal 
Address  Room No. 01, Ground Floor, Bhel Sangam Chouraha, Danish Nagar, Bagsewaniya, Bhopal

Bhopal
MADHYA PRADESH
462026
India 
Phone  7777888008  
Fax    
Email  Kuldeepkatariya3@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr R Valavan 
Designation  Head- Scientific and Medical Affairs 
Affiliation  Dr. Willmar Schwabe India Pvt Ltd 
Address  A-36, Scientific Department, First Floor, Sector-60, Noida (U.P)

Gautam Buddha Nagar
UTTAR PRADESH
201304
India 
Phone  9312309186  
Fax    
Email  dr.valavan@schwabeindia.com  
 
Details of Contact Person
Public Query  
Name  Dr Mukul Maurya 
Designation  Director- ProClin Research Private Limited  
Affiliation  PROCLIN RESEARCH PRIVATE LIMITED 
Address  Room No. 1, Second Floor, Plot#1, Nevri Hills Gufa Mandir Road, Lalghati

Bhopal
MADHYA PRADESH
462030
India 
Phone  7032802286  
Fax    
Email  mukul@proclinresearch.com  
 
Source of Monetary or Material Support  
Dr. Willmar Schwabe India Pvt Ltd 
 
Primary Sponsor  
Name  Dr Willmar Schwabe India Pvt Ltd 
Address  A-36, Scientific Department, First Floor, Sector 60, Noida, U.P.-201304, India 
Type of Sponsor  Other [Private Manufacturers of alternative medicine] 
 
Details of Secondary Sponsor  
Name  Address 
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 Kuldeep Katariya  Jeevandan Multispeciality Hospital  Room No. 01, Ground Floor, Bhel Sangam Chouraha, Danish Nagar, Bagsewaniya, Bhopal
Bhopal
MADHYA PRADESH 		 7777888008

Kuldeepkatariya3@gmail.com 
Dr Vikrant Khanna  Mata Roop Rani Maggo Hospital  Room No. 14, Basement-1, Department of Orthopedics, Metro pillar no. 709,Om Vihar phase 1 ,Uttam Nagar ,New Delhi -110059
West
DELHI 		 7760390344

vikrantkhannadr@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Good Society for Ethical Research  Approved 
Institutional ethics committee Charak Hospital   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M199||Osteoarthritis, unspecified site,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Placebo  Identical Placebo Capsule at a dose of 125 mg administered twice daily administered orally for 12 weeks 
Intervention  XtraBosTM Capsule  XtraBosTM Capsule (Boswellia Serrata Extract) at a dose of 125 mg twice daily administered orally for 12 weeks. 
 
Inclusion Criteria  
Age From  35.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Participants of either sex aged above 35 years to 65 years
2. Participants with a score of 4 or more on the Visual Analogue Score (VAS)
3. Participants with Osteoarthritis Index (WOMAC) > 0
4. Participants with hypertension ≥140/90 mmHg and or neuropathic pain and or sleep disorder clinically assessed via Neuropathic Pain Symptom Inventory (NPSI) and Sleep Interference Numerical Rating Scale (S-NRS).
5. Participants with symptoms consistent with generalized pain or OA for at least six months prior to screening
6. Patients who are continuing any NSAIDS or other analgesic medication taken for any other condition including current generalized pain.
7. Participants with non-significant safety profile CBC, LFT, RFT and Lipid.
8. Participants who are able to understand written or verbal instructions and are willing to comply with all study requirements along with voluntarily willing to sign a written informed consent. 
 
ExclusionCriteria 
Details  1. Participants having history of Blood and lymphatic system disorder, cardiac disorder apart from hypertension, congenital familial and genetic disorder, immune system disorder, neoplasms benign, malignant and unspecified disorder, psychiatric disorder, Renal and urinary disorder.
2. Participants having history of drug or alcohol abuse or dependence during the last six months.
3. Participants having history of known allergy to Boswellia Serrata Extract.
4. Women participant of child bearing potential who are either unwilling or unable to use and acceptable method of birth control (Such as Oral Contraceptives,
other hormonal contraceptives, or IUD’s) to avoid Pregnancy during the study period.
5. Participants who have participated in an investigational drug trial less than 60 days prior to the screening visit.
6. Participants of vulnerable group. (Children, Lactating Mother, Elderly above 80 years and Handicapped).
7. Participant likely to not be available to complete all protocol-required study visits or procedures.
8. History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the Investigator or Sponsor physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Other 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Difference in Mean Average Daily Pain (ADP) Score using 11-point Numerical Rating Scale (NRS)
2. Difference in Osteoarthritis Index (WOMAC) 		 By Week 4, week 8 & week 12 
 
Secondary Outcome  
Outcome  TimePoints 
1. Difference in Visual Analogue Scale (VAS) For Assessment of Generalized Pain
2. Difference in total & sum score of Neuropathic Pain Symptom Inventory (NPSI)
3. Difference in Mean Sleep Interference Numerical Rating Scale (S-NRS)
4. Difference in Mean Global Impression of Change (GPIC)
5. Difference in mean blood pressure and percent usage of NSAIDS 		 By Week 4, week 8 & week 12 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   28/07/2023 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   This is a randomized, double-blind study in adult participants with VAS Score 4 and above. A total of 100 subjects (50 per treatment group) will be randomized (1:1) to receive investigational product (IP)- XtraBosTM Capsule (Boswellia Serrata Extract) or Placebo at a dose of 125 mg twice daily administered orally for 12 weeks.
Osteoarthritis (OA) is known as a degenerative joint disease that affects millions of elderly people and population having comorbidities of hypertension, neuropathic pain and sleep disorders throughout the world. In most cases, OA patients experience synovial inflammation and cartilage loss, which causes pain and immobility. Nearly 50% of the people aged 65 or older on a global scale are believed to have OA symptoms. We hypothesize that XtraBosâ„¢ will prevent OA pain and inflammation in human along with improvements in comorbidities like hypertension, neuropathic pain and sleep disorders
A subject will remain on study until week 12. Subjects who discontinue IP before week 12 will be followed for 2 weeks after the last dose of IP and then complete the end-of-study visit. An independent data monitoring team (DMT) will evaluate the safety data throughout the study, including an initial safety review after the first 12 subjects have received at least 2 doses of IP.
 
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