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CTRI Number  CTRI/2025/01/079569 [Registered on: 27/01/2025] Trial Registered Prospectively
Last Modified On: 23/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   The Impact Of Marma Chikitsa On Plantar Fasciitis Will Be Evaluated Through A Randomized Controlled Trial Involving 30 Patients. 
Scientific Title of Study   To Evaluate The Efficacy Of Marma Chikitsa In The Pain Management Of Plantar Fasciitis (Vatkantak). 
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 Sayed Tanveer Altaf 
Designation  MD Scholar Rachna Sharir 
Affiliation  Pt Khushilal Sharma Govt.(Auto) Ayurveda College and Institute Bhopal Madhya Pradesh. 
Address  PG Department of Rachna Sharir Pt Khushilal Sharma Govt.(Auto) Ayurveda College and Institute Bhopal Madhya Pradesh.

Bhopal
MADHYA PRADESH
462003
India 
Phone  9575595557  
Fax    
Email  tanveeraltaf09@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Nisha Bhalerao 
Designation  Reader Department of Rachna Sharir  
Affiliation  Pt Khushilal Sharma Govt.(Auto) Ayurveda College and Institute Bhopal Madhya Pradesh. 
Address  PG Department of Rachna Sharir Pt Khushilal Sharma Govt.(Auto) Ayurveda College and Institute Bhopal Madhya Pradesh.

Bhopal
MADHYA PRADESH
462003
India 
Phone  9424542272  
Fax    
Email  nmandlik10@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sayed Tanveer Altaf 
Designation  MD Scholar Rachna Sharir 
Affiliation  Pt Khushilal Sharma Govt.(Auto) Ayurveda College and Institute Bhopal Madhya Pradesh. 
Address  PG Department of Rachna Sharir Pt Khushilal Sharma Govt.(Auto) Ayurveda College and Institute Bhopal Madhya Pradesh.

Bhopal
MADHYA PRADESH
462003
India 
Phone  9575595557  
Fax    
Email  tanveeraltaf09@gmail.com  
 
Source of Monetary or Material Support  
PG Department of Rachna Sharir Pt Khushilal Sharma Govt.(Auto) Ayurveda College and Institute Bhopal Madhya Pradesh. 
 
Primary Sponsor  
Name  Pt Khushilal Sharma Govt.(Auto) Ayurveda College and Institute Bhopal Madhya Pradesh. 
Address  PG Department of Rachna Sharir Pt Khushilal Sharma Govt.(Auto) Ayurveda College and Institute Bhopal Madhya Pradesh. 
Type of Sponsor  Government funding agency 
 
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 Sayed Tanveer Altaf  Pt Khushilal Sharma Govt.(Auto) Ayurveda College and Institute Bhopal Madhya Pradesh.  PG Department of Rachna Sharir Pt Khushilal Sharma Govt.(Auto) Ayurveda College and Institute Bhopal Madhya Pradesh.
Bhopal
MADHYA PRADESH 		 9575595557

tanveeraltaf09@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Commette Pt. Khushilal Sharma Government Ayurveda Institute,Bhopal (Madhya Pradesh)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M959||Acquired deformity of musculoskeletal system, unspecified. Ayurveda Condition: VATAKANTAKAM,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-marmacikitsA, मर्मचिकित्सा (Procedure Reference: Dr Sunil Kumar Joshi, Procedure details: Marma Sthana to be stimulated 15-18 times for 0.8 sec once a day.)
2Comparator ArmDrugOther than Classical(1) Medicine Name: Roasted Wheat Flour, Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: -Sukhoshna Jal), Additional Information: -
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patients between the age 20 to 60 years.
2.Patients with symptoms of recent onset.
3.Patients with pain, swelling, tenderness, over medial aspect around the heel and stiffness in the morning.
4.Patient willing to be registered for study with written consent.
5.Patients of either sex.
6.With all cardinal symptoms of the disease. 
 
ExclusionCriteria 
Details  1.Calcaneal stress fracture, R.A., Gout,Neoplastic condition, nerve entrapment syndromes.
2.Subjects with improper circulation to lower extremities.
3.Subjects with referred pain due to sciatica & other neurological disorders.
4.Corticosteroid injections to heel, preceding 3 months. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
It is expected that at the end of study, scholar will be able To evaluate the efficacy of Marma Chikitsa in the pain management of “Plantar Fasciitis” (Vatkantak).   15 days  
 
Secondary Outcome  
Outcome  TimePoints 
It is cost effective and give instant relief in pain.  15 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   N/A 
Date of First Enrollment (India)   05/02/2025 
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 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   Plantar Fasciitis is a cause of heel pain due to inflammation of fascia in adults with the highest incidence occurring in those aged 40 to 60 years. In these study the assessment has done on the basis of subjective and objective parameter of Plantar Fasciitis. The overall effect of Marma Chikitsa is extremely significant. 
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