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CTRI Number  CTRI/2024/05/068001 [Registered on: 28/05/2024] Trial Registered Prospectively
Last Modified On: 30/09/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Efficacy of a turmeric-boswellia extract in sesame seed oil in knee osteoarthritis. 
Scientific Title of Study   A Randomized Double-Blinded Placebo-Controlled Study to Determine the Efficacy of Curcuma longa - Boswellia serrata Extract in black Sesamum indicum Seed Oil (Rhuleave-K) in Subjects with Knee Osteoarthritis. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
AN-09PFK1123H7-WES19 Version 1 dated 21 Feb 2024  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Binu T Kuruvilla 
Designation  Chief Innovation Officer 
Affiliation  Arjuna Natural Pvt Ltd 
Address  Arjuna Natural Pvt Ltd, Bank Road, Aluva

Ernakulam
KERALA
683101
India 
Phone  09447818432  
Fax    
Email  drbinu@arjunanatural.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Binu T Kuruvilla 
Designation  Chief Innovation Officer 
Affiliation  Arjuna Natural Pvt Ltd 
Address  Arjuna Natural Pvt Ltd, Bank Road, Aluva


KERALA
683101
India 
Phone  09447818432  
Fax    
Email  drbinu@arjunanatural.com  
 
Details of Contact Person
Public Query  
Name  Sooraj Rajasekharan Kartha 
Designation  Scientist- Clinical Research 
Affiliation  Arjuna Natural Pvt Ltd 
Address  Arjuna Natural Pvt Ltd, Bank Road, Aluva

Ernakulam
KERALA
683101
India 
Phone  9847670997  
Fax    
Email  sooraj@arjunanatural.com  
 
Source of Monetary or Material Support  
Arjuna Natural Pvt Ltd Bank Road, Aluva Ernakulam 683101 KERALA 
 
Primary Sponsor  
Name  Arjuna Natural Pvt Ltd 
Address  Arjuna Natural Pvt Ltd, Bank Road, Aluva -683101, Ernakulam KERALA, INDIA. 
Type of Sponsor  Other [Nutraceutical] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Madhu Geddam  Srikara Hospitals  Department of ortho, consultant room ground floor,#222&223, Phase II, Mythri Nagar, Madinaguda, Miyapur, Hyderabad-500049.
Hyderabad
TELANGANA 		 8328671684

drmadhu.srikarahospitals@gmail.com 
Dr Rakesh Komuravelli  Srikara Hospitals  Department of ortho, consultant room ground floor, Street no.7, Near RTC X Road, Beside Nabard, Musheerabad, Zamistanpur, kavdiguda- 500020.
Hyderabad
TELANGANA 		 9866113630

dr.rakeshkomuravelli@gmail.com 
Dr Ram Kamal  Srikara Hospitals  Department of ortho, consultant room ground floor, Plot no.50, LB Nagar, Hyderabad-500074.
Hyderabad
TELANGANA 		 8978696455

drramkamal.srikarahospitals@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Shrikara Hospitals Ethics Committee  Approved 
Shrikara Hospitals Ethics Committee  Approved 
Shrikara Hospitals Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Placebo   500 mg soft gel capsule once daily for 12 weeks 
Intervention  Rhuleave-K  C.longa – B.serrata extract in black S.indicum seed oil 500 mg soft gel capsule once daily for 12 weeks 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Male or Female 40 to 70 years of age with 1:1 gender ratio.
NRS score greater than or equal to 5 pain intensity on walking at the time of screening
BMI 18 to 29 kg/m2
Doctor diagnosed OA of knee–with Kellgren–Lawrence classification grades 1-2
Willing to give voluntary written informed consent. 
 
ExclusionCriteria 
Details  History of rheumatoid arthritis, severe osteoarthritis, gout, all other forms of arthritis, moderate or severe synovitis (KL grade 3 or over), meniscal rupture, fibromyalgia, underlying back pain, history of knee surgery, expectations of surgery in the next 4 months, and delayed onset of muscle soreness.
BMI greater than or equal to 30
High alcohol intake (greater than 2 standard drinks per day)
Smoking status not more than 1 pack per day.
Psychotic tendencies such as schizophrenia, taking any psychotropic medicines.
Psychedelic or narcotic substance use
Co-morbid illnesses such as cardiovascular, endocrine, renal or other chronic disease or limit normal function.
Those who have a history of using glucosamine sulphate, chondroitin sulphate, intra-articular hyaluronate, or systemic or intra-articular glucocorticoid within the past 3 months and during experiment period.
Those with a history of taking anti-inflammatory drugs, boswellia, curcumin, omega-3 fatty acids, or collagen supplements within 30 days, during experiment period or who have used them chronically.
Concomitant medications antibiotics, NSAIDS, steroids, OTC pills and ointments for pain 1 week before screening.
Any serious acute or chronic medical condition that in the judgment of the investigator would make it inappropriate for the subject to participate in this study.
Positive pregnancy, breast feeding, pregnancy planning.
Subjects who have participated in a similar investigation in the past three months.
Unwilling to provide written informed consent. 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Mean change in the WOMAC total score  Baseline to D3, D5, D7, D42, and D84 
 
Secondary Outcome  
Outcome  TimePoints 
Mean change in McGill  from baseline to D3, D5, D7, D42, & D84 
Mean change in LFI  from baseline to D3, D5, D7, D42, & D84. 
Mean change in NRS score  D1, D3, D5, D7, D42, & D84 
Mean change in PRS score  D1, D3, D5, D7, D42, & D84. 
Proportion of subjects using rescue medication  from baseline to D3, D5, D7, D42, & D84. 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "96"
Final Enrollment numbers achieved (India)="96" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   07/06/2024 
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="8"
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   Osteoarthritis (OA), a degenerative disease that affects the joints is a leading cause of chronic musculoskeletal disability especially in the elderly populations worldwide but also affects athletes and younger individuals.OA is characterized by pain, stiffness in the morning, joint edema, restricted range of motion, diminished physical function, social activity restriction, and/or impaired work capacity. Articular cartilage and subchondral bone of synovial joints are the main targets of OA, which causes joint failure and pain during weight-bearing activities like standing and walking.In this study the investigators focus on a new formulation of turmeric (Curcuma longa) and boswellia (Boswellia serrata) extracts blended in black sesame (Sesamum indicum) seed oil using a proprietary technology.This study is a randomized double blinded placebo controlled clinical trial to determine the efficacy olf Rhuleave-K in subjects with Knee osteoarthritis. The sample size taken was 100 subjects and the treatment period is for 12 weeks. The primary outcome measure is womac.  
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