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CTRI Number  CTRI/2026/03/105680 [Registered on: 09/03/2026] Trial Registered Prospectively
Last Modified On: 07/03/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Physiotherapy (Not Including YOGA) 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   A Clinical trail to compare the efficacy of Raktamokshana alongwith Erandataila pana AND Wax therapy alongwith Exercise in the management of Plantar Fasciitis 
Scientific Title of Study   A Double-Arm clinical trial to evaluate the efficacy of Raktamokshana along with Erandataila pana in comparison to Wax Therapy along with Exercise in the management of 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 ATHULYA P V 
Designation  PG scholar 
Affiliation  AMRITA SCHOOL OF AYURVEDA 
Address  Department Of Shalya Tantra AMRITA SCHOOL OF AYURVEDA Clappana (PO),Kollam Kerala PIN :690525

Kollam
KERALA
690525
India 
Phone  8281919972  
Fax    
Email  athulyapv97@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr SHAITHYA RAJ 
Designation  PROFESSOR AND HOD ,Department of Shalya Tantra 
Affiliation  AMRITA SCHOOL OF AYURVEDA 
Address  Department Of Shalya Tantra AMRITA SCHOOL OF AYURVEDA Clappana(PO),Kollam Kerala PIN :690525

Kollam
KERALA
690525
India 
Phone  9495434862  
Fax    
Email  shaithya.raj@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr SHAITHYA RAJ 
Designation  PROFESSOR AND HOD ,Department of Shalya Tantra 
Affiliation  AMRITA SCHOOL OF AYURVEDA 
Address  Department Of Shalya Tantra AMRITA SCHOOL OF AYURVEDA Clappana (PO),Kollam Kerala PIN :690525

Kollam
KERALA
690525
India 
Phone  9495434862  
Fax    
Email  shaithya.raj@gmail.com  
 
Source of Monetary or Material Support  
Amrita School Of Ayurveda Clappana(PO),Kollam PIN :690525 
 
Primary Sponsor  
Name  Dr ATHULYA P V 
Address  Amrita School Of Ayurveda Clappana (PO),Kollam PIN:690525 
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 ATHULYA P V  Amrita School Of Ayurveda  Amrita School Of Ayurveda Clappana (PO),Kollam,Kerala PIN:690525
Kollam
KERALA 
8281919972

athulyapv97@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee,Amrita School Of Ayurveda  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. Ayurveda Condition: VATAKANTAKAM,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-raktamokShaNam/ SoNitasrAvaH/ asravisrutiH/ SastravisrAvaNam, रक्तमोक्षणम्/ शोणितस्रावः/ अस्रविस्रुतिः/शस्त्रविस्रावणम् (Procedure Reference: Vangasena, Procedure details: Poorvakarma Vitals of patients are taken prior. Yavagu is given Stanika abhyanga and swedana given. A torniquet is tied on leg above the ankle joint to make sira prominent. Pradhanakarma After identifying the prominent sira ,a scalp vein set of number 21 is used for puncturing the vein which is 2A above kshipra marma. About 50-100ml of blood is withdrawn from the site. Paschatakarma After bloodletting the punctured area is cleaned and dressed . Vitals are taken after the procedure Raktamokshana (siravyadha) will be conducted thrice in a gap of 7 days.)
2Comparator Arm (Non Ayurveda)-Wax therapy along with ExerciseWax therapy with paraffin wax and active ankle exercises
3Intervention ArmDrugClassical(1) Medicine Name: Eranda Taila, Reference: Bhaishajya Ratnavali, Route: Oral, Dosage Form: Taila, Dose: 10(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: Ushanodaka), Additional Information: nil
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients between 20- 65 yrs of age are selected irrespective of their religion, sex, occupation and socio economic status who were diagnosed on the basis of signs and symptoms found in Plantar fasciitis.

Patients with plantar heel pain provoking by first few steps in morning ,standing for prolonged time or sitting.

Patients with tenderness localised at origin of plantar fascia on medial calcaneal tubercle.

Positive Windlass test.

Patients who are not suffering from any bleeding disorders.
 
 
ExclusionCriteria 
Details  Patients who are contraindicated to Raktamokshana.
Patient associated with calcaneal spur or calcaneal stress fracture.
Patients with previous history of foot surgeries.
Patients associated with generalised inflammatory conditions including Rheumatoid Arthritis, Gout .
Patients associated with diabetes mellitus, skin rashes, burns and allergic conditions over heel region.
Patients with varicose ulcer in foot.
Patients who uses NSAID daily.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Changes in Pain (tool-VAS SCORE)
 
Baseline ,8th day and 15th day 
 
Secondary Outcome  
Outcome  TimePoints 
Changes in Foot Function (FFI index)
Changes in Range of motion –dorsiflexion,plantar flexion (by goniometer).
Changes in Windlass test(+ve or-ve) 
Baseline ,8th day & 15th day 
 
Target Sample Size   Total Sample Size="36"
Sample Size from India="36" 
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 
Date of First Enrollment (India)   23/03/2026 
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="10" 
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 - NO
Brief Summary  

Plantar fasciitis is a common degenerative condition of the plantar fascia at the medial calcaneal tuberosity, affecting about 10% of the population annually. Symptoms include heel pain, morning stiffness, and difficulty in daily activities. Current treatments include physiotherapy, wax therapy, NSAIDs, and corticosteroid injections; however, long-term use of steroids and NSAIDs may cause adverse effects. In Ayurveda, the condition is correlated with Vatakantaka, for which classics prescribe Raktamokshana (siravyadha) and Erandataila Pana .

Modern studies highlight the role of wax therapy and stretching exercises in improving circulation, pain, and function, though requiring frequent sessions. Case studies on Raktamokshana with Erandataila suggest significant improvement with fewer sittings, indicating cost-effectiveness and reduced patient burden.

This open-label, double-arm comparative clinical trial will recruit 36 patients (20–65 yrs) with plantar fasciitis from OPD/IPD of Amrita School of Ayurveda. Group A will receive Raktamokshana (Siravyadha, 3 sittings) with Erandataila Pana (10 ml daily), while Group B will undergo Wax therapy (10 sessions) with Exercise. Assessments will be made using VAS score, Foot Function Index (FFI), ankle range of motion, and Windlass test over 15 days.

The research hypothesis states that there is a significant difference between the two interventions in reducing pain, improving foot function, and ankle range of motion. Statistical analysis will be done using Independent t-test / Mann–Whitney U test, and Friedman test for intra-group comparisons.

The study aims to establish whether fewer sessions of Raktamokshana with Erandataila Pana can provide results comparable or superior to conventional wax therapy with exercise, potentially offering an effective and economical treatment option for plantar fasciitis
.

 
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