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CTRI Number  CTRI/2024/06/069586 [Registered on: 27/06/2024] Trial Registered Prospectively
Last Modified On: 27/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Siddha 
Study Design  Single Arm Study 
Public Title of Study   Uloga Suttigai for vathathambam 
Scientific Title of Study   An open single arm clinical trial to determine the effectiveness of Uloga Suttigai (Metal Cauterization) in the management of Vathathambam (Sciatica) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  N A Adlinnivetha 
Designation  PG Scholer 
Affiliation  National Institute of Siddha 
Address  Room No 14 Department of Puramaruthuvam National Institute of Siddha Tambaram Sanatorium Kancheepuram Tamil Nadu 600047 India

Kancheepuram
TAMIL NADU
600047
India 
Phone  7598657299  
Fax    
Email  adlinufiyabsms3@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  D Periyasami  
Designation  Associate Professor 
Affiliation  National Institute of Siddha 
Address  Room No 14 Department of Puramaruthuvam National Institute of Siddha Tambaram Sanatorium Kancheepuram Tamil Nadu 600047 India

Kancheepuram
TAMIL NADU
600047
India 
Phone  7358481734  
Fax    
Email  sami2011nis@gmail.com  
 
Details of Contact Person
Public Query
 
Name  D Periyasami  
Designation  Associate Professor 
Affiliation  National Institute of Siddha 
Address  Room No 14 Department of Puramaruthuvam National Institute of Siddha Tambaram Sanatorium Kancheepuram Tamil Nadu 600047 India

Kancheepuram
TAMIL NADU
600047
India 
Phone  7358481734  
Fax    
Email  sami2011nis@gmail.com  
 
Source of Monetary or Material Support  
Ayothidoss Pandithar hospital National Institute of Siddha Tambaram sanatorium-600047 Kancheepuram Tamilnadu 
 
Primary Sponsor  
Name  National Institute of Siddha 
Address  Room No 14 Department of Pura Maruthuvam National institute of Siddha Tambaram Sanatorium-600047 Kancheepuram district  
Type of Sponsor  Research institution and hospital 
 
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 N A Adlinnivetha  Ayothidoss pandithar hospital  Room no 14 Department of Puramaruthuvam National Institute of Siddha Tambaram sanatorium Kancheepuram Tamilnadu
Kancheepuram
TAMIL NADU 
7598657299

adlinufiyabsms3@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M543||Sciatica,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  Suttigai for Vathathambam   The copper suttigai will heated upto red hot and to be touched at the tender points of affected site number of sitting maximum 5 times interval between the two procedure once in 7 days  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1 Presence of low back pain
2 Presence of burning pain numbness paresthesia and tingling sensation
3 A positive SLR test
4 Willing to give blood samples for investigation
5 Willing to take photographs
6 Willing to participate in trial and signing consent by fulfilling the condition of proforma
 
 
ExclusionCriteria 
Details  Known history infective arthritis
Known history of fracture of malunion
History of uncontrolled diabetes mellitus
Pregnant and lactating women
Known case of limb weakness and foot drop
Chronic alcoholism
Psychiatric illness
Rheumatoid arthritis
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The therapeutic effectiveness of Uloga suttigai for the management of sciatic pain will be determined by visual analogue scale and Oswestry low back disability index   48 days 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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 3 
Date of First Enrollment (India)   01/08/2024 
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 Yet Recruiting 
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  

BACKGROUND

The Siddha system of medicine is based on a combination of ancient medical practices and spiritual disciplines In the text Yugi vaythiya chinthamani Yugimunivar classified the Vadha disease as 80 types and Vadathambam is one among them.In modern medicine Vathathambam may be correlated with Sciatica Sciatica pain is the most common musculo skeletal conditions that have life time prevalence of up to 70 percentage and this seems to be increasing in incidences Sciatica is condition in which the patient experience pain and or paresthesias in the sciatic nerve distribution or an associated lumbo sacral nerve root the sciatic nerve is made up of the L4 through S2 nerve roots which coalesce at the pelvis to form the sciatic nerve At upto 2cm in diameter the sciatic nerve is easily largest nerve in the body Sciatic pain often is worsened with flexion of the lumbar spine twisting bending or coughing The sciatic nerve provides direct motor function to the hamstrings lower extremity adductors and indirect motor function to the calf muscle anterior lower leg muscle and some intrinsic foot muscles Also indirectly through its terminal branches the sciatic nerve provides sensation to the posterior and lateral lower leg and the plantar aspect of the foot The straight leg raise test is a passive examination Typically pain that is reproduced between 30 to 70 degrees of hip flexion and experienced primarily in the back is likely due to a lumbar disc herniation In modern medicine the condition is managed by electro therapy hydrotherapy and exercise therapy to the patients Suttigai is one of the 32 external medicines found in Siddha literatures under the topic Puramarunthugal Vathathambam is caused by vitiated Vatham In chronic condition Kabam also added with vitiated Vatham and produce severe symptoms and signs In Suttigai procedure is mostly used in chronic and severe symptoms This Suttigai procedure act over cutaneous receptor and first cause sharp pain through ascending pathway and activate the descending pathway endogenous analgesic system Periaqueductal grey matter PAGdorsal raphe nucleus nucleus raphe Magnus and medial reticular column which involves the various chemicals

Suttigai therapy is non pharmocological cost effective economically non viable easy to perform even at remote areas for management of sciatica

OBJECTIVE

To study the therapeutic effectiveness of Uloga Suttigai (Metal cauterization) in reducing the clinical signs and symptoms of Vathathambam (Sciatica) through VAS scale and Oswestry low back Disability Index

STUDY DESIGN

An open single arm clinical trial with a total number of 30 diagnosed patient of Vathathambam Sciatica reporting at Ayothidoss Pandithar hospital National Institute of Siddha will be enrolled in the study patients having history of uncontrolled Diabetes Rheumatoid arthritis Chronic alcoholism Psychiatric illness Limb weakness Foot drop fracture infective arthiritis Pregnant and Lactating women will excluded The trial procedure suttigai will be given for 48 days

 
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