| CTRI Number |
CTRI/2024/12/078385 [Registered on: 20/12/2024] Trial Registered Prospectively |
| Last Modified On: |
20/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Compare Efficacy Of Agnikarma and Viddhagnikarma Along With Vishwadidwadashang kashaya In the Management Of Vatkantaka W.S.R to Plantar Fascitis |
|
Scientific Title of Study
|
A Randomised Comparative Clinical Trial To Evaluate Efficacy Of Agnikarma And Viddhagni Karma Along With Vishwadi Dwadashang Kashaya In The Management Of Vatkantaka With Special Refference To Plantar Fascitis |
| 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 Nandan Santosh Lahoti |
| Designation |
PG scholar |
| Affiliation |
Matoshri Asarabai Darade Ayurved hospital affiliated with Matoshri Asarabai Darade Ayurved college |
| Address |
Matoshri Asarabai Darade Ayurved hospital, OPD NO 04/05 Shalya OPD,ground floor ,
Matoshri Asarabai Darade Ayurved college
,SND campus,Babhulgaon Tal- YEOLA , Dist- Nashik ,
Matoshri Asarabai Darade Ayurved college,Babhulgaon Tal- YEOLA , Dist- Nashik
Nashik
MAHARASHTRA
423401
India |
| Phone |
8308221820 |
| Fax |
|
| Email |
nanlahoti747@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manoj Sonaje |
| Designation |
HOD and PROF , Department of Shalyatantra |
| Affiliation |
Matoshri Asarabai Darade Ayurved hospital affiliated with Matoshri Asarabai Darade Ayurved College |
| Address |
Shalyatantra Department ,Second floor ,Matoshri Asarabai Darade Ayurved College,SND Campus , Babhulgaon , Tal.YEOLA
Matoshri Asarabai Darade Ayurved hospital , Shalyatantra OPD ,OPD No.04 /05 Ground floor ,
SND Campus ,Babhulgaon , Tal.YEOLA
Nashik
MAHARASHTRA
423401
India |
| Phone |
9423932283 |
| Fax |
|
| Email |
manojsonaje@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nandan Santosh Lahoti |
| Designation |
PG Scholar |
| Affiliation |
Matoshri Asarabai Darade Ayurved hospital affiliated with Matoshri Asarabai Darade Ayurved College |
| Address |
Matoshri Asarabai Darade Ayurved hospital, Shalyatantra OPD ,OPD no 04/05,Ground floor
,SND Campus Babhulgaon Tal- YEOLA , Dist- Nashik
Matoshri Asarabai Darade Ayurved College, Shalyatantra Department, Second floor
,SND Campus ,Babhulgaon , Tal.YEOLA
Nashik
MAHARASHTRA
423401
India |
| Phone |
8308221820 |
| Fax |
|
| Email |
nanlahoti747@gmail.com |
|
|
Source of Monetary or Material Support
|
| Matoshri Asarabai Darade Ayurved college and Matoshri Asarabai Darade Ayurved hospital
Babhulgaon , Tal.Yeola
Dist - Nashik
Maharashtra,India
423401 |
|
|
Primary Sponsor
|
| Name |
Matoshri Asarabai darade ayurved college |
| Address |
Shalyatantra department Matoshri Asarabai darade ayurved college and Shalyatantra OPD ,Matoshri Asarabai Darade ayurved hospital |
| 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 Nandan Santosh Lahoti |
Matoshri Asarbai Darade Ayurved College and Matoshri Asarbai Darade Ayurved hospital |
OPD no.04 /05 Shalya OPD Matoshri Asarbai Darade Ayurved hospital
Shalyatantra Department Matoshri Asarbai Darade Ayurved college
Babhulgaon, Tal-Yeola
423401
Nashik
MAHARASHTRA |
8308221820
nanlahoti747@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Matoshri Asarabai Darade Ayurved College |
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 | Comparator Arm | Procedure | - | Viddhagnikarma | (Procedure Reference: Sushrut Samhita, Procedure details: Viddhagnikarma by Suchi on 0th and 7th day)
(1) Medicine Name: Vishwadidwadashang kashay, Reference: Bharat bhaishajya Ratnakar, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 40(ml), Frequency: bd, Duration: 14 Days | | 2 | Intervention Arm | Procedure | - | agnikarma, अगà¥à¤¨à¤¿à¤•à¤°à¥à¤® | (Procedure Reference: Sushrut Samhita, Procedure details: Agnikarma by Rajat Shalaka (Bindu dahan vishesh)
on 0th and 7th day)
(1) Medicine Name: Vishwadidwadashang Kashay , Reference: Bharat bhaishajya Ratnakar , Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 40(ml), Frequency: bd, Duration: 14 Days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient with Pratyatm lakshnas of vatakantaka i.e, pain in the
plantar aspect of heel, pain on keeping the first step in the
morning with or without local swelling, stiffness and
tenderness |
|
| ExclusionCriteria |
| Details |
Below 20 and 60 + age group
Calcaneus spur, Calcaneal stress fracture, RA, gout, neoplastic condition,
nerve entrapment syndromes.(pre diagnosed)
Subjects with impaired circulation to lower extremities
ï‚· Subjects with referred pain due to sciatica & other neurological disorders
( pre diagnosed)
Corticosteroid injections to heel, preceding 3 months text.
Patient associated with known H/O any systemic
Disease like DM, HTN, HIV, HbSAg, spinal surgery
agnikarma ayogya |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvement in heal pain and Restricted Movement will be
assessed on 7th, 14th 21st and 28th day |
On 7th, 14th , 21st and 28th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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)
|
01/01/2025 |
| 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 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 also called policeman’s heel. An inflammation of a thick band of tissue that connects the heel bone to the toes. The inflamed tissue runs across the bottom of the foot. Plantar fasciitis is one of the most common causes of heel pain. Sushrutacharya states that the disease treated by Agnikarma will not recur again.The results of agnikarma by Rajat shalaka and Viddhagnikarma in the management of vatkantaka has been proven. We are comparing both arms along with Vishwadidwadshang kashay internally for better results. To overcome limitations of modern management, in the present study with a special importance will made by selecting effective, safe, simple therapeutic modality.
|