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CTRI Number  CTRI/2025/05/086995 [Registered on: 15/05/2025] Trial Registered Prospectively
Last Modified On: 12/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Role of venesection in the Management of Burning feet syndrome 
Scientific Title of Study   An Anatomical Exploration of Pada Sira and Clinical Efficacy of Siravyadha in the Management of Padadaha  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Snehal Vitthal Payghan 
Designation  MD Scholar 
Affiliation  Institute of Teaching and Research in Ayurveda, Jamnagar, Gujarat 
Address  Room no 21, Department of Rachana Sharir, Dhanvantari Mandir, Near DKV circle, Jamnagar, Gujarat 361008
Opp. B-Division Police Station, Gurudwara Road, jamnagar, Gujarat 361008
Jamnagar
GUJARAT
361008
India 
Phone  8180919386  
Fax    
Email  payghansnehal1997@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Kalpana Raje 
Designation  HOD 
Affiliation  Institute of Teaching and Research in Ayurveda, Jamnagar, Gujarat  
Address  Room no 16, Department of Rachana Sharir, Dhanvantari Mandir, Near DKV circle, Jamnagar, Gujarat 361008

Jamnagar
GUJARAT
361008
India 
Phone  9227724551  
Fax    
Email  rajekalpana25@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Kalpana Raje 
Designation  HOD 
Affiliation  Institute of Teaching and Research in Ayurveda, Jamnagar, Gujarat  
Address  Room no 16, Department of Rachana Sharir, Dhanvantari Mandir, Near DKV circle, Jamnagar, Gujarat 361008

Jamnagar
GUJARAT
361008
India 
Phone  9227724551  
Fax    
Email  rajekalpana25@gmail.com  
 
Source of Monetary or Material Support  
Institute of Teaching and Research in Ayurveda Jamnagar Gujarat 
 
Primary Sponsor  
Name  Institute of Teaching and Research in Ayurveda, Jamnagar, Gujarat 
Address  Opp. B-Division Police Station, Gurudwara Road, Jamnagar, Gujarat 361008 
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 
Snehal Vitthal Payghan  Institute of Teaching and Research in Ayurveda, Jamnagar  Shalya Tantra OPD 18 and 19, Institute of Teaching and Research in Ayurveda, Jamnagar
Jamnagar
GUJARAT 
8180919386

payghansnehal1997@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Institute of Teaching and Research in Ayurveda, Jamnagar, Gujarat  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E889||Metabolic disorder, unspecified. Ayurveda Condition: PADADAHAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-sirAvedhaH, सिरावेधः (Procedure Reference: Sushruta Samhita Sharir Sthan verse 8/5, Procedure details: The selected vein will be punctured with an instrument (Needle no 26). It will be carried out two times by 15 days of interval.)
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Hb% greater than 10 gm%
2. Patients Diagnosed with burning feet syndrome caused due to Diabetic Peripheral Neuropathy, Hypothyroidism, and Vit B12 deficiency.
3. Patients who are willing to participate and sign the informed consent form. 
 
ExclusionCriteria 
Details  1. Hb% less than or equal to 10 gm %
2. Patients with uncontrolled Diabetes or Hypertension, Patients with
complications of Metabolic disorders like Cerebrovascular accident (CVA),
Myocardial Infarction (MI), chronic kidney disease (CKD).
3. Patients suffering from bleeding disorders, HIV, TB other infectious diseases,
Malignancies, major psychiatric problems.
4. pregnant women, lactating women. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
It is expected that trial treatment protocol will provide relief in signs and symptoms of Padadaha   1 Month 
 
Secondary Outcome  
Outcome  TimePoints 
It know the Efficacy of Siravyadha in the management of Padadaha  1 Month 
 
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   N/A 
Date of First Enrollment (India)   20/05/2025 
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response (Others) -  through Publications after completion of the study

  6. For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Introduction: Acharya Sushruta, the father of surgery has given immense value to the therapeutic aspects of Raktamokshana. Sushruta considers Siravyadha as a type of Raktamokshana, which is described under the purification process of body in Ayurveda. The Siravyadha is an emergency management of many diseases to achieve better result where Snehana, Lepana etc measures are not giving proper results. As quoted in Sushrut Samhita, the site for Siravyadha in Padadaha is two Angula above the Kshipra Marma in Adhoshakha. and Kshipra Marma is located in between Padangushta and Anguli. The burning sensation in the soles of the feet caused by the enraged local Vayu, in conjunction with the deranged Pitta and Rakta is called Padadaha and it is a common disorder especially among the elderly and is frequently encountered in general practice. 
Rationality For the Selection of The Topic: The incidence of Padadaha is increasing day by day in today’s population due to altered lifestyle and sickening dietary habits. In Padadaha, burning pain is the predominant symptom, which disturb daily activities. Acharya Sushruta mentioned that Siravyadha is the better treatment for Padadaha and it should be done at two Angula above Kshipra Marma. So, it is necessary to find out the Sira in Pada present two Angula above the Kshipra Marma and to know the efficacy of Siravyadha in the management of Padadaha 
Aims and Objectives
Aim: 1. To find out the precise location of Sira in Pada which is two Angula above the Kshipra Marma by cadaveric dissection. 2. To assess the efficacy of Siravyadha at two Angula above Kshipra Marma in the management of Padadaha.
Objectives: 1. To study Vedhya-Avedhya Sira as per the available literatures. 2. To precise the location and explore the Sira in Pada which is two Angula above the Kshipra Marma by cadaveric dissection. 3. To find out the efficacy of Siravyadha in Padadaha. Materials And Methods:30 patients having signs and symptoms of Padadaha between the age group 18 to 60 years will be selected in the clinical study. 
Results And Discussion: In this study, obtained data will be analyzed on the basis of proper logics and reasoning to find out the exact location of Sira used for Siravyadha in the management of Padadaha and further conclusions will be derived from the study    

 
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