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CTRI Number  CTRI/2015/06/005864 [Registered on: 03/06/2015] Trial Registered Prospectively
Last Modified On: 24/12/2016
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 of LCOX to check its efficacy and tolerability in osteoarthritis patients of Knee. 
Scientific Title of Study   A randomized Double blind placebo controlled trial to check Efficacy and tolerability of LCOX- an herbal formulation in osteoarthritis of Knee. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Pankaj Prabhakar Dixit 
Designation  Asso Professor 
Affiliation  Ayurved Seava Sanghs Ayurved Mahavidyalaya Nashik 
Address  Department of Shalyatantra, Ayurved Seava Sanghs Ayurved Mahavidyalaya Nashik Nashik MAHARASHTRA 422003 India

Nashik
MAHARASHTRA
422003
India 
Phone  9011045371  
Fax  0253-2517170  
Email  drpankajpdixit@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DrAmol Deshmukh 
Designation  R&D Executive 
Affiliation  Pharmanza Herbal Pvt. Ltd. 
Address  Pharmanza Herbal Pvt. Ltd. Plot No. 214 Borsad-Tarapur Road, Vadadla Patia Kaniya-388435 Tq. Petlad, Dist.Anand Gujrat.

Anand
GUJARAT
388435
India 
Phone  9898652936  
Fax    
Email  rd@pharmanzaherbals.com  
 
Details of Contact Person
Public Query  
Name  DrAmol Deshmukh 
Designation  R&D Executive 
Affiliation  Pharmanza Herbal Pvt. Ltd. 
Address  Pharmanza Herbal Pvt. Ltd. Plot No. 214 Borsad-Tarapur Road, Vadadla Patia Kaniya-388435 Tq. Petlad, Dist.Anand Gujrat.

Anand
GUJARAT
388435
India 
Phone  9898652936  
Fax    
Email  rd@pharmanzaherbals.com  
 
Source of Monetary or Material Support  
Pharmanza Herbal Pvt Ltd 
 
Primary Sponsor  
Name  Pharmanza Herbal Pvt Ltd 
Address  Borsad Tarapur road, Near Darmoj crossroad, Vadadla Patiya, Kaniya-388435, Tq. Petlad, Dist Anand, Gujrat.  
Type of Sponsor  Other [Herbal Company ] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Pankaj Prabhakar Dixit  Ayurved Sanshodhan Vibhag, Ayurved Seva Sangh, Nashik  Ayurved Sanshodhan Vibhag, Ayurved Seva Sangh, Nashik. Ganeshwadi, Panchavati, Nashik -422003 Nashik MAHARASHTRA
Nashik
MAHARASHTRA 		 0253-2512097
0253-2512097
sanshodhanayusevansk@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, A.S.S. Ayurved Mahavidyalaya Nashik. Ganeshwadi, Panchavati, Nashik (Maharashtra)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  osteoarthritis of knee joints,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Plcebo  contains dextrin 500mg Dosage: 2 tablets twice a day Route of administration: oral Duration of treatment: 2 months  
Intervention  Tablet LCOX   LCOX contains: Boswellia Serrata 300 mgs Withania Somnifera 100 mgs Cissus quadrangularis 100 mg Dosage: 2 tablets twice a day. Route of administration: oral Duration of treatment: 2 months  
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  a. Clinico-radiologically diagnosed patients of OA
knee
b. Patients willing to participate and give signed
informed consent
c. Either gender
d. Age >40 years
 
 
ExclusionCriteria 
Details  a. History of peptic ulcer, acid peptic disease or
any other concurrent illness
b. End organ damage. RFT, LFT will be conducted
pre and post session.
d. Chronic smoker/ alcoholic
e. History of allergy against herbal products or
NSAIDs
f. Subjects who cannot be relied upon to comply
with instructions
g. Pregnant or breast feeding women
h. Gouty Arthritis, Rheumatoid Arthritis,
Psoriatic
arthritis.
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
difference between WOMAC score in two groups
 		 at baseline after one month after second month  
 
Secondary Outcome  
Outcome  TimePoints 
decrease in level of CTX2 in urine samples of two groups.  at baseline and after second month  
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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 2 
Date of First Enrollment (India)   10/06/2015 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   data obtained in this study will be used to publish in peer reviewed journals.  
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   This study is a randomized double blind parallel group placebo controlled study, this study is aimed to check efficacy and tolerability of Lcox tablets in knee osteoarthritis patients of either sexes.  Lcox is FDA approved polyherbal formulation of Pharmanza Herbal Pvt. Ltd. Each tablet of Lcox contains
1. Shallaki (Boswellia Serrata) 300mg
2. Ashwagandha (Withania Somnifera) 100mg
3. Hadjod (Cissus quadrangularis) 100mgfrom 
2 Lcox tablets twice a day will be given to patient in trial group of fifty patients. 2 placebo tablets twice a day will be given to patients in placebo group. treatment will be continue for 2 months for each patient and monthly assessment will be done using WOMAC scale. Data will be recorded and will be used to publish in peer reviewed journals.
 
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