| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M722||Plantar fascial fibromatosis. Ayurveda Condition: VATAKANTAKAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | 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.)
| | 2 | Comparator Arm (Non Ayurveda) | | - | Wax therapy along with Exercise | Wax therapy with paraffin wax and active ankle exercises | | 3 | Intervention Arm | Drug | Classical | | (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. |