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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition:E889||Metabolic disorder, unspecified. Ayurveda Condition: PADADAHAH, |
|
Intervention / Comparator Agent
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | 1 | Intervention Arm | Procedure | - | 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
- 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).
- 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
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response (Others) - through Publications after completion of the study
- 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.
- 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 |