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CTRI Number  CTRI/2023/05/053028 [Registered on: 22/05/2023] Trial Registered Prospectively
Last Modified On: 28/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Applied Anatomy of Siravyadha in Medial Marginal Vein in Context of Plantar Fascitis 
Scientific Title of Study   A Clinical Study to Evaluate the Applied Anatomy of Siravyadha in Medial Marginal Vein and Dorsal Venous Arch in Context of Plantar Fascitis 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vidhyaprabha R 
Designation  Associate Professor 
Affiliation  Yenepoya Ayurveda Medical College and Hospital 
Address  Dept. of Rachana Sharira Mangaluru

Dakshina Kannada
KARNATAKA
575018
India 
Phone  6363409207  
Fax    
Email  drvidhyaprabha@yenepoya.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Vidhyaprabha R 
Designation  Associate Professor 
Affiliation  Yenepoya Ayurveda Medical College and Hospital 
Address  Dep. of Rachana Sharira Mangaluru

Dakshina Kannada
KARNATAKA
575018
India 
Phone  6363409207  
Fax    
Email  drvidhyaprabha@yenepoya.edu.in  
 
Details of Contact Person
Public Query  
Name  Vidhyaprabha R 
Designation  Associate Professor 
Affiliation  Yenepoya Ayurveda Medical College and Hospital 
Address  Dept of Rachana Sharira Mangaluru
Mangaluru
Dakshina Kannada
KARNATAKA
575018
India 
Phone  6363409207  
Fax    
Email  drvidhyaprabha@yenepoya.edu.in  
 
Source of Monetary or Material Support  
PDEAs College of Ayurved and Research Centre, Nigdi, Pune, Maharashtra 
Poornaayu Arogya Niketanam, Govt. High School Road, Meenangadi, Wayanad, Kerala 
Yenepoya Ayurveda Medical College, Naringana, Deralakatte,Mangaluru, Karnataka 
 
Primary Sponsor  
Name  Vidhyaprabha R 
Address  Dept of Rachana Sharira Yenepoya Ayurveda Medical College and Hospital Naringana Deralkatte Mangaluru 575018 
Type of Sponsor  Other [Self funded] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dinesh Naik  PDEAs College of Ayurved and Research Centre  Out Patient Department
Pune
MAHARASHTRA 		 9145458644

drdineshnaik27@gmail.com 
Dr Aparna Padmanabhan  Purnayoo Arogya Nikethanam  Out Patient Department
Wayanad
KERALA 		 9995551346

info@purnayoo.com 
Vidhyaprabha R  Yenepoya Ayurveda Medical College and Hospital  Out Patient Department
Dakshina Kannada
KARNATAKA 		 6363409207

drvidhyaprabha@yenepoya.edu.in 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 4  
Name of Committee  Approval Status 
Institutional Ethical Committee  Approved 
Institutional Scientific Review Board  Approved 
Kanachur Ayurveda Medical College Hospital  Approved 
Purnayoo Arogyanikethanam  No Objection Certificate 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M958||Other specified acquired deformities of musculoskeletal system. Ayurveda Condition: VATAKANTAKAM,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-sirAvedhaH, सिरावेधः (Procedure Reference: , Procedure details: Siravedha is done in medial marginal vein as per the classical method)
2Comparator ArmProcedure-sirAvedhaH, सिरावेधः (Procedure Reference: , Procedure details: Siravedha is done in dorsal venous arch as per classical method)
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patients between 30 yrs. - 60yrs of age, selected irrespective of sex, religion, occupation and socioeconomic status were diagnosed on the basis of signs and symptoms found in Plantar fasciitis
2. Plantar heel pain provoked by first few steps in morning, by standing after prolonged sitting or by prolonged standing.
3. Tenderness localized at the origin of plantar fascia on medial calcaneal tubercle.
4. Positive Windlass test
 
 
ExclusionCriteria 
Details  1. Calcaneal spur
2. Calcaneal stress fracture
3. Previous treatment with ultrasound within 3 months
4. Previous foot surgeries.
5. Tarsal tunnel syndrome.
6. Generalized inflammatory disorders associated with diagnosis of plantar fasciitis including Rheumatoid arthritis, Ankylosis Spondylitis, Reiter’s disease, Gout or Lupus.
7. Neoplastic conditions, Nerve entrapment syndromes
8. Participants with impaired circulation to lower extremities
9. Subjects with referred pain due to sciatica and other neurologic disorders
10. Corticosteroid injections to heel, preceeding 3 months.
11. Use of pain control (NSAIDS, Analagesics), steroids, heel pads or orthoses at time of recruitment.
12. Any other major illnesses
 
 
Method of Generating Random Sequence   Adaptive randomization, such as minimization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The pain will be assessed using visual analogue scale pain scoring  1 week 
 
Secondary Outcome  
Outcome  TimePoints 
Efficacy of pain releif of siravedha in median marginal vein and dorsal venous arch will be assessed and compared  1 year 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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)   01/06/2023 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   Not Applicable 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Plantar fasciitis is the utmost common cause of chronic pain beneath the heel in adults, making up 11-15% of the foot symptoms requiring professional care.  It is estimated that 1 in 10 people will develop plantar fasciitis during their lifetime.  Although plantar fasciitis occurs at all ages, the highest risk of occurrence of it is in 40 – 60 years of age.  In Ayurveda, the condition may be considered under a vatavyadhi called vatakantaka for which Acharya Sushruta mentions siravyadha as treatment.  The site for siravyadha in vatakantaka is mentioned in Sushruta Samhita as 2 angulas above kshipra marma2.  This site is relevant to the course of dorsal venous arch.  However, there are conventional practices prevalent in Kerala where siravyadha is done in the medial aspect of gulpha sandhi which is also observed to give good relief.  The conventional site for siravyadha is relevant to the medial marginal vein.  This study is aimed at understanding the applied anatomy of siravyadha in dorsal venous arch and medial marginal vein in view of the areas of foot it drains.  

Null Hypothesis:  There is no anatomical significance to siravyadha in medial marginal vein and dorsal venous arch in plantar fasciitis

Primary Alternate Hypothesi:  There is anatomical significance to siravyadha in medial marginal vein and dorsal venous arch in plantar fasciitis

 
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