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CTRI Number  CTRI/2024/02/062253 [Registered on: 05/02/2024] Trial Registered Prospectively
Last Modified On: 03/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Other (Specify) [Siravedha]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A Randomized Controlled Clinical Study To Edvaluate The Efficicacy Of Siravedha And Eranda Taila Orally In Vatakanatak With Special Reference To Reference To Plantar Fasciitis. 
Scientific Title of Study   A randomized controlled clinical study to evaluate the efficacy of Siravedha and Eranda Taila orally in Vatakanatak with special reference to Plantar Fasciitis  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Dipali Rohidas Shinde 
Designation  PG Scholar 
Affiliation  Government Ayurved College and Hospital, Vazirabad, Nanded 
Address  Dept Of Shalyatantra, Government Ayurved College, Vazirabad, Nanded

Nanded
MAHARASHTRA
431601
India 
Phone  08805907065  
Fax    
Email  shindedipali71@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rajendra Sonekar  
Designation  H. O. D and Professor  
Affiliation  Government Ayurved College and Hospital, Vazirabad, Nanded 
Address  Dept Of Shalyatantra, Government Ayurved College, Vazirabad, Nanded

Nanded
MAHARASHTRA
431601
India 
Phone  9822578033  
Fax    
Email  rajendra.sonekar@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Rajendra Sonekar  
Designation  H. O. D and Professor  
Affiliation  Government Ayurved College and Hospital, Vazirabad, Nanded 
Address  Dept Of Shalyatantra, Government Ayurved College, Vazirabad, Nanded


MAHARASHTRA
431601
India 
Phone  9822578033  
Fax    
Email  rajendra.sonekar@gmail.com  
 
Source of Monetary or Material Support  
Government Ayurved College, Vazirabad, Nanded  
 
Primary Sponsor  
Name  Dr Dipali Rohidas Shinde  
Address  Dept Of Shalyatantra Government Ayurved College and Hospital, Vazirabad, Nanded 
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 
Dr Dipali Rohidas Shinde  Government Ayurved Hospital, Vazirabad, Nanded  Dept Of Shalyatantra Hospital building OPD NO 6 & 7 IPD ward NO 53 & 73
Nanded
MAHARASHTRA 		 08805907065

shindedipali71@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee, Government Ayurved College,Nanded   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M708||Other soft tissue disorders related to use, overuse and pressure. Ayurveda Condition: VATAKANTAKAM,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-sirAvedhaH, सिरावेधः (Procedure Reference: Bhaishajya Ratnavali, Procedure details: Siravedha of dorsal metatarsal vein is done. This procedure is done once a week for three weeks.)
(1) Medicine Name: ErandaTaila, Reference: Bhaishajya Ratnavali, Route: Oral, Dosage Form: Taila, Dose: 5(ml), Frequency: hs, Duration: 15 Days
2Comparator Arm (Non Ayurveda)-Tablet Diclofenac sodiumTablet Diclofenac sodium is given twice a day for seven days with hot fomentation.
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patients will be selected irrespective of sex, chronicity.
2. patients of age group 18-60 suffering from only vatakanatak (Plantar Fasciitis).
3. patients with pratyatma lakshana of vatakanatak vyadhi i.e pain in plantar aspect of heel, tenderness.
4. patients having pain at plantar region in presence of normal plain radiograph of foot (AP & lateral view). 
 
ExclusionCriteria 
Details  1. Anarhas of siravedha mentioned in classics.
2. Patients having uncontrolled DM, HTN or any severe systemic diseases.
3. calcaneal stress fracture.
4. The patients clinically assessed with impaired circulation to lower extremities.
5. Patients with referred pain due to sciatica & other neurological disorders.
6. Bleeding disorders.
7. Those patients who need other emergency interventions like surgery and other means are excluded.
8. Anaemic patients.
9. HIV, HBSAG reactive patients are also excluded.
10. Malignant & immunocompromised patients are also excluded.
11. patients on treatment of anticoagulants  
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Reduced pain in plantar region   16 days 
 
Secondary Outcome  
Outcome  TimePoints 
1. Reduced tenderness in plantar region
2. Normal movements of ankle joints  		 17 days 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   13/02/2024 
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="3"
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   This study is prospective, randomized, open labelled, controlled  clinical  study to evaluate the efficacy of siravedha once a week for 3 weeks and Eranda Taila 5ml HS orally for 15 days with assesment on 0, 8th and 17th day in Vatakanatak with special reference to Plantar fasciitis. This study is conducted as PG course at single centre. The primary outcome is to study the efficacy of Siravedha and Eranda Taila oraaly in Vatakanatak with special reference to Plantar Fasciitis. 
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