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CTRI Number  CTRI/2023/11/060321 [Registered on: 29/11/2023] Trial Registered Prospectively
Last Modified On: 28/11/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Siddha 
Study Design  Other 
Public Title of Study   VATHAROGA CHOORANAM for Cervical Spondylosis 
Scientific Title of Study   PHASE II NON RANDOMIZED OPEN CLINICAL EVALUATION OF SIDDHA MEDICINE VATHAROGA CHOORANAM FOR THE MANAGEMENT OF SAGANAVATHAM (CERVICAL SPONDYLOSIS) 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sathya Nandini T  
Designation  PG Scholar 
Affiliation  Government Siddha Medical College,Chennai 
Address  Post Graduate Department of Pothu Maruthuvam, Government Siddha Medical College Arumbakkam, Chennai.

Chennai
TAMIL NADU
600106
India 
Phone  8610042435  
Fax    
Email  sathyanandini14@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Chitra U 
Designation  Lecturer 
Affiliation  Government Siddha Medical College, Chennai  
Address  Post Graduate Department of Pothu Maruthuvam,Government Siddha Medical College, Arumbakkam ,Chennai.

Chennai
TAMIL NADU
600106
India 
Phone  9445716802  
Fax    
Email  mmsankar2000@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Sathya Nandini T 
Designation  PG Scholar 
Affiliation  Government Siddha Medical College  
Address  Post Graduate Department of Pothu Maruthuvam, Government Siddha Medical College Arumbakkam, Chennai.

Chennai
TAMIL NADU
600106
India 
Phone  8610042435  
Fax    
Email  sathyanandini14@gmail.com  
 
Source of Monetary or Material Support  
Government Siddha Medical College, Arumbakkam, Chennai  
 
Primary Sponsor  
Name  Sathya Nandini T  
Address  Post Graduate Department of Pothu Maruthuvam, Government Siddha Medical College, Arumbakkam, Chennai. 
Type of Sponsor  Other [Self] 
 
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 
Sathya Nandini T   Government Siddha Medical College, Chennai   Room No.S1, Department of PG Pothu Maruthuvam, Arumbakkam, Chennai.
Chennai
TAMIL NADU 
8610042435

sathyanandini14@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee of Government Siddha Medical College,Chennai.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M472||Other spondylosis with radiculopathy,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  VATHAROGA CHOORANAM  The Siddha drug will be given as 1500mg BD dose with Honey,for 48 days for the management of Cervical Spondylosis. 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Neck pain radiating to upper limb with or without numbness,giddiness and neck stiffness.
Shoulder abduction pain relief sign -positive
Lhermittes and spurlings sign - positive 
 
ExclusionCriteria 
Details  Known case of
Ankylosing spondylitis
Adhesive capsulitis
Traumatic injury
Extra cervical rib
Congenital spinal anomalies
Tuberculosis of spine
Secondary malignancy
Ischemic heart disease
Type II Diabetes Mellitus
chronic kidney disease
Pregnant women and lactating mothers
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Reduction in clincal symptoms such as neck pain radiating to upper limb,numbness,neck stiffness.  3 WEEKS 
 
Secondary Outcome  
Outcome  TimePoints 
VISUAL ANALOGUE SCALE  7 WEEKS 
 
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)   10/12/2023 
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)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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   Cervical spondylosis is the result of osteoarthritis in the cervical spine. It is characterised
by degeneration of the intervertebral discs and osteophyte formation. Such ‘wear and tear’ is
extremely common and radiological changes are frequently found in asymptomatic individuals
over the age of 50. Spondylosis may be associated with neurological dysfunction. .Osteoarthritis of the cervical spine may produce neck pain that radiates into the back of the head, shoulders, or arms, or may be the source of headaches in the posterior occipital region
(supplied by the C2-C4 nerve roots).As the disks dehydrate and shrink, signs of osteoarthritis develop including bony projections along the edges of the bone. Cervical spondylosis is very common and worsens with
age. More than 85 percent of people older than age 60 are affected by cervical spondylosis.
The point prevalence of neck pain ranges from 0.4% to 41.5%, the 1-year incidence rangesfrom 4.8 to 79.5%[.The incidence of neck pain in adults in India is 25-50% per year. About 10million persons per year affected in India alone.
In Siddha system of Medicine, there are unique combination of medicines which have the
solution to the SAGANAVATHAM (CERVICAL SPONDYLOSIS). One such combination is
VATHAROGA CHOORANAM which will be cost effective and reliable.
As the literary evidences support the usage of medicine in the disease, a hypothesis
created in such a way that the efficacy of the VATHAROGA CHOORANAM will be a better
solution for SAGANAVATHAM (CERVICAL SPONDYLOSIS) and so permission may be given.
 
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