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CTRI Number  CTRI/2018/03/012351 [Registered on: 06/03/2018] Trial Registered Retrospectively
Last Modified On: 01/03/2018
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Siddha 
Study Design  Single Arm Study 
Public Title of Study   Thandaga vatham (Lumbar spondylosis) treated with Kustathi choornam (Internal)and Eranda thylam (External)  
Scientific Title of Study   An Open Clinical Study to evaluate the clinical efficacy of siddha sasthric formulation "KUSTATHI CHOORNAM"(Internal) "ERANDA THYLAM"for the treatment of THANDAGA VATHAM. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Malarvizhi 
Designation  Pg student 
Affiliation  Government siddha medical college 
Address  Department of Pg sirappu maruthuvam government siddha medical college palayamkottai

Tirunelveli
TAMIL NADU
627002
India 
Phone    
Fax    
Email  malarvizhimayilsamy@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr A S Poongodi kanthimathi 
Designation  Head of the department 
Affiliation  Government siddha medical college 
Address  Department of Pg sirappu maruthuvam government siddha medical college palayamkottai

Tirunelveli
TAMIL NADU
627002
India 
Phone    
Fax    
Email  arunapriya1995@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr M Malarvizhi 
Designation  Pg student 
Affiliation  Government siddha medical college 
Address  Department of Pg sirappu maruthuvam government siddha medical college palayamkottai

Tirunelveli
TAMIL NADU
627002
India 
Phone    
Fax    
Email  malarvizhimayilsamy@gmail.com  
 
Source of Monetary or Material Support  
OPD&IPD of government siddha medical college library of government siddha medical college 
 
Primary Sponsor  
Name  Dr S Neelavathi 
Address  Principal Government siddha medical college Palayamkottai Tirunelveli 
Type of Sponsor  Government medical college 
 
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 M Malarvizhi  Government siddha medical college  op number 4 Pg department of sirappu maruthuvam
Tirunelveli
TAMIL NADU 		 9962482583

malarvizhimayilsamy@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
institutional ethical committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Pain in lumbo sacral region radiating towards both lower limbs numbness of both lower limb ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Kustathi choornam (Internal) Eranda thylam (External)  Kustathi choornam 1 gram tds with hot Water(Internal) Eranda thylam 30 ml thylam(External) for 48 days 
Comparator Agent  Not applicable  Not applicable 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patients having symptoms of Pain in the lumbar region
2.Radiating pain to buttocks and lower limbs
3.stiffness present in lumbar region
4.Exacerbation of pain on movements
5.Pain increased on forward bending
6.Tingling sensation.(Numbness)
7.Patients who are willing to give radiological investigation and provide blood for lab investigation.
8.Patient willing to sign the informed consent stating that he/she will conscientiously stick to the treatment during 48 days but can option out of the trial of his/her own conscious discretion.
 
 
ExclusionCriteria 
Details  1.Cardiac disease
2.Auto immune diseases like Rheumatoid 3.arthiritis, SLE, Psoriasis, Mixed connective tissue disorder.
4.Spina bifida
5.Liver Disease
6.Pregnancy and lactation
7.Osteo myelitis
8.Renal Disease
9.Tuberculosis in spine
10.Patient with any other serious illness
11.Other systemic illness
12.Dislocation

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
reducing pain in Lumbosacral region and both lower limb Reducing numbness and radiating pain
 		 48days
 
 
Secondary Outcome  
Outcome  TimePoints 
Evalution of siddha diagnostic parametes  48 days 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   05/09/2017 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   Phase II criteria based clinical study to evaluate the clinical efficacy of siddha polyherbal formulation Kustathi choornam 1 gram tds with hot water (Internal) and Eranda thylam 30ml (External) for the treatment of Thandaga vatham (Lumbar spondylosis) for 48 days in 40 patients during the trail period of 1 year 6 months conducted in government siddha medical college and hospital , palayamkottai , tirunelveli , tamilnadu . the primary outcome will be the Reducing pain in Lumbosacral region and both lower limb reducing numbness and radiating pain .the secondary outcome will be the  evaluation  of siddha diagnostic parameters  .                          
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