FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2019/06/019744 [Registered on: 18/06/2019] Trial Registered Prospectively
Last Modified On: 17/06/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Management of heel pain  
Scientific Title of Study   A comparative clinical study on the efficacy of Siravyadhana and Parisheka of Dashamoola kwatha followed by Parisheka of Ksheerbala Taila in the management of Vatakantaka W.S.R to Plantar fasciitis 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ajaya Kumar Meher 
Designation  Pg Scholar 
Affiliation  All India Institute Of Ayurveda 
Address  Room no 112 Panchakarma Theatre All India Institute Of Ayurveda Gautampuri Sarita Vihar

New Delhi
DELHI
110076
India 
Phone  8448431251  
Fax    
Email  meherajaya@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Prasanth Dharmarajan 
Designation  Assistant Professor 
Affiliation  All India Institute Of Ayurveda 
Address  Seventh Floor Department Of Panchakarma All India Institute Of Ayurveda, Gautampuri Sarita vihar New delhi

New Delhi
DELHI
110076
India 
Phone  9895174060  
Fax    
Email  drprasanthd@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Santoshkumar Bhatted 
Designation  Associate Professor 
Affiliation  All India Institute Of Ayurveda 
Address  7th Floor Department Of Panchkarma All India Institute Of Ayurveda Gautampuri Sarita vihar New delhi

New Delhi
DELHI
110076
India 
Phone  9414048459  
Fax    
Email  santoshbhatted@rediffmail.com  
 
Source of Monetary or Material Support  
All India Institute Of Ayurveda Gautampuri Sarita Vihar New Delhi Pin 110076 
 
Primary Sponsor  
Name  All India Institute Of Ayurveda 
Address  Gautampuri Sarita Vihar New delhi 110076 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Ajaya Kumar Meher  All India Institute Of Ayurveda  Seventh Floor Department Of Panchakarma All India Institute Of Ayurveda Gautampuri Sarita Vihar New Delhi
New Delhi
DELHI 		 8448431251

meherajaya@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M722||Plantar fascial fibromatosis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Parisheka of Dashamoola Kwatha and Ksheerbala Taila  2 days Koshtha Shuddhi ,then Parisheka of Dashamoola Kwatha and Ksheerbala Taila for 7 days each then Kaishora Guggulu 2 tabs three times a day for 30 days. 
Comparator Agent  Siravyadhana  2 days Koshtha Shuddhi.Then,4 sittings of Siravyadhana at an interval of 7 days. After 7 days of gap, Kaishora Guggulu medication 2tabs three times a day for 30 days.  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1) Patients presenting with symptoms of pain swelling and stiffness in heels.

2) Socioeconomic condition all
3) Upto 5 years chronicity.
 
 
ExclusionCriteria 
Details  1) Patients who have undergone longterm treatment for many years.
2) Anaemic patients
3) Patients with bleeding disorders.
4) Diabetic patients
5) Patients with severe systemic disorders.
• Patients Ayogya for Swedana therapy.
• Patients Ayogya for Rakta Mokshana.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Symptomatic Relief based on assessment scale.  90 days 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in quality of life.  90 days 
 
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 2/ Phase 3 
Date of First Enrollment (India)   30/06/2019 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Research will be published in reputed journal. 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   Plantar fasciitis is a disorder that results in pain in the heel and bottom of the foot. The pain is usually most severe with the first steps of the day or following a period of rest. Pain is also frequently brought on by bending the foot and toes up towards the shin and may be worsened by a tight Achilles tendon.The condition typically comes on slowly. In about a third of people both legs are affected. In Ayurveada, Plantar fasciitis can be coorelated with Vatakantaka.Vata Dosha takes Vatakantaka isone of the Vata Nanatmaja Vyadhi,severe aching pain is experienced, the foot is kept in an unusual posture or when the local area is fatigued due to excess function a chance and occupies the ankle joint and heal;it is called Vatakantaka 
In this study,30 patients will be enrolled and divided into two groups by permuted block randomization.In first group,Koshtha shuddhi  followed by 4 sittings of Siravyadhana at an interval of 7 days will be done.In second group, Koshtha shuddhi  followed by  Parisheka of Dashamool Kwatha for 7 days will be done.Then after a gap of 7 days,Parisheka of Ksheerbala Taila will be done for next 7 days.Then in both the groups,Kaishora Guggulu as Shamana Aushadhi will be given as follow-up medications for 30 days.Assessment will be done as per assessment criteria.
 
Close