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CTRI Number  CTRI/2020/10/028725 [Registered on: 29/10/2020] Trial Registered Prospectively
Last Modified On: 23/07/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A Clinical study to evaluate the efficacy and tolerability of 5-LOXIN in patients with mild osteoarthritis of knee 
Scientific Title of Study   A randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and tolerability of 5-LOXIN in subjects with mild osteoarthritis of knee 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
LN/OA/LI13115/20, Version 1.0 Dated: 01-Jun-2020   Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Awadhesh Kumar Yadav 
Designation  Orthopedic Surgeon 
Affiliation  Sri Ram Ortho and Physio Rehab Centre 
Address  Department of Orthopedics, Room no 4, Ground floor, Sri Ram Ortho and Physio Rehab Centre (A unit of Anwesha Surgicals hospital Private Limited) SA:15/59D-A-10, Balua Road, Renu Nagar, Sarnath

Varanasi
UTTAR PRADESH
221007
India 
Phone  9598061499  
Fax    
Email  aradhanay.pharma@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Golakoti Trimurtulu  
Designation  Senior Vice President Technical  
Affiliation  Laila Nutraceuticals  
Address  Laila Nutraceuticals,Room No 13 Ground Floor R&D Block Surevy No 181 by 2 JRD Tata Industrial Estate Kanuru Vijayawada

Krishna
ANDHRA PRADESH
520007
India 
Phone  08666636666   
Fax  08662546216   
Email  drgt@lailanutra.in  
 
Details of Contact Person
Public Query  
Name  Alluri Venkata Krishna Raju 
Designation  General Manager  
Affiliation  Laila Nutraceuticals  
Address  Laila Nutraceuticals Room No 17 Ground Floor R&D Block Surevy No 181 by 2 JRD Tata Industrial Estate Kanuru Vijayawada

Krishna
ANDHRA PRADESH
520007
India 
Phone  08666636666   
Fax  08662546216   
Email  avkr@lailanutra.in  
 
Source of Monetary or Material Support  
Laila Nutraceuticals R&D Block Surevy No 181 by 2 JRD Tata Industrial Estate Kanuru Vijayawada Krishna District ANDHRA PRADESH 520007 India  
 
Primary Sponsor  
Name  Ju Yeong NS Co Ltd 
Address  1404 - 10, A-Dong, Songpa Tera Tower #2, 201,Songpa-daero, Songpa-gu, Seoul, Republic of Korea, zip code: 05854 
Type of Sponsor  Other [Nutraceuticals Industry] 
 
Details of Secondary Sponsor  
Name  Address 
Laila Nutraceuticals   40-15-14, Brindavan Colony, Labbipet Vijayawada-520 010 Andhra Pradesh India 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Nandlal Prasad  Bajarang Memorial Fracture, Accidental and Surgical Centre  Department of Orthopedics, Room no 2, Ground floor, Shiveapur Bypass, Babatpur Road
Varanasi
UTTAR PRADESH 		 9454976095

sunilverma.shiv@gmail.com 
Dr Awadhesh Kumar Yadav   Sri Ram Ortho and Physio Rehab Centre (A unit of Anwesha Surgicals hospital Private Limited)  Department of Orthopedics, Room no 4, Ground floor, SA:15/59D-A-10, Balua Road, Renu Nagar, Sarnath
Varanasi
UTTAR PRADESH 		 9598061499

aradhanay.pharma@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Opal Institutional Ethics Commitee  Approved 
Opal Institutional Ethics Commitee  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 
Intervention  5-Loxin  One capsule (250mg) daily after meal for 56 days administered Orally 
Comparator Agent  Placebo  One capsule (250mg) daily after meal for 56 days administered Orally 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Subjects who signed an informed consent form voluntarily to participate in the study
Both gender, between 40 and 70 years.
VAS (Visual Analogue Scale) 30 to 70 mm.
K/L grade of knee I, II on X-ray
 
 
ExclusionCriteria 
Details  Subject with other than degenerative arthritis [osteoarthritis] determined by investigator.
Subject whose joint space is decreased by less than 2mm.
Subject with severe arthritis accompanied by bone spurs around joint, irregular articular surface, chondrogenesis, and bone cyst.
Subject with clinically significant cardiovascular, immunization, infective, or neoplastic diseases.
Subject being treated for gastritis or gastric ulcer.
Subject with uncontrolled hypertension (over 140/95mmHg measured at screening).
Subject with uncontrolled diabetes mellitus (more than 125mg/dl of fasting glucose measured at screening).
Subject with AST (GOT) and ALT (GPT) ≥ 3 times the upper limit of normal.
Subject with Creatinine ≥ 2 times the upper limit of normal.
Subject who is pregnant or planning to become pregnant within 3 months or who is lactating.
Subjects took intra articular injections including hyaluronic acid or subjects had corticosteroid therapy in last 3 months.
Subject administered medication including NSAIDs or health functional foods related to arthritis within 30 days of screening.
Subject with mental disorders such as schizophrenia, depressive disorder and drug intoxication /Subject with severe mental illness.
Subject planning to participate in the other clinical trial or subject participated in any clinical trial within 3 month.
Inappropriate subject decided by the investigator.
Subject who has septic arthritis, inflammatory joint disease, palindromic pseudogout, paget disease, joint fracture, ochronosis, acromegaly, hematochromatosis, Wilson disease, primary Osteochondrosis, genetic disorder (ex, hyperkinesia), collagen abnormality.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Improvement from baseline to the end of the supplementation period in VAS (Visual Analogue Scale)
 		 Screening, Day 14, Day 28 and Day 56
 
 
Secondary Outcome  
Outcome  TimePoints 
Change from baseline to the end of the study in WOMAC
 		 Day 1, Day 14, Day 28 and Day 56 
Change from baseline to the end of the study in Bio-markers   Day 1 and Day 56 
Change from baseline to the end of the study in Improvement in osteoarthritis by Subject Global Assessment (SGA) and Physician Global Assessment (PGA)   Day 14, Day 28 and Day 56 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" 
Phase of Trial   N/A 
Date of First Enrollment (India)   30/10/2020 
Date of Study Completion (India) 17/11/2020 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 07/04/2021 
Estimated Duration of Trial   Years="0"
Months="8"
Days="10" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Nil 
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, placebo-controlled 2 arm clinical study to evaluate the efficacy and tolerability of 5-LOXIN in subjects with mild osteoarthritis of knee. 
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