| CTRI Number |
CTRI/2024/11/077353 [Registered on: 26/11/2024] Trial Registered Prospectively |
| Last Modified On: |
25/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To access combined effect of viddhakarma and agnikarma with agnikarma in Vatakantaka with reference to plantar fascitis |
|
Scientific Title of Study
|
A randomized controlled clinical trial to evaluate add on effect of Viddhakarma with Agnikarma in the management of Vatakantaka. |
| 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 Tanveer Mohamad Hayat Patil |
| Designation |
PG Scholar |
| Affiliation |
PDEAs college of ayurveda and reasearch centre Nigdi Pune. |
| Address |
PDEAs College Of Ayurved And Research Centre Third floor,
Shalyatantra Department, Sector no. 25, pradhikaran, Nigdi
Pune
MAHARASHTRA
411044
India |
| Phone |
8208132480 |
| Fax |
|
| Email |
tanveerpatil00@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bharat K oza |
| Designation |
Associate Professor |
| Affiliation |
PDEAs college of ayurveda and reasearch centre Nigdi Pune. |
| Address |
PDEAs College Of Ayurved And Research Centre Third floor,
Shalyatantra Department, Sector no. 25, pradhikaran, Nigdi
Pune
MAHARASHTRA
411044
India |
| Phone |
9970254593 |
| Fax |
|
| Email |
drbharat_oza@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bharat K oza |
| Designation |
Associate Professor |
| Affiliation |
PDEAs college of ayurveda and reasearch centre Nigdi Pune. |
| Address |
PDEAs College Of Ayurved And Research Centre Third floor,
Shalyatantra Department, Sector no. 25, pradhikaran, Nigdi
Pune
MAHARASHTRA
411044
India |
| Phone |
9970254593 |
| Fax |
|
| Email |
drbharat_oza@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| PDEAs college of ayurveda and reasearch centre Nigdi Pune Maharashtra 411004 India |
|
|
Primary Sponsor
|
| Name |
PDEAs college of Ayurveda and Research centre Nigdi Pune |
| Address |
PDEAS College of Ayurved and Research Centre,Third
floor,Shalyatantra department Sector no.25,Nigdi Pradhikaran,Pune
Pune
MAHARASHTRA
411044
India
Phone
9970254593 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| DrTanveer Mohamad Hayat Patil |
Ayurved Rugnalaya And Sterling Multispeciality hospital Nigdi Pune |
Shalyatantra
Department OPD-123A
Pradhikaran Nigdi pune
Pune
Pune
MAHARASHTRA |
8208132480
tanveerpatil00@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical committee |
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 | - | Agnikarma and vidhakarma | (Procedure Reference: Sushruta samhita, Procedure details: patients will be examined for the location of the most tenderness site. Then circle will be drawn on tenderness site & then two points will be marked in circle by pen, one for Viddha karma & one for agnikarma.The heel region then cleaned with spirit swab.By using disposable Needle no. 26, one points pierced at 45 degrees angle up to depth 3-4 mm.
The needle will be placed in the same position for half a minute then made out of the body. The local area again cleaned with dry gauze piece.
The disposable needle used only once on the patient & will be discarded after it was used once.
No dressing will be performed & the local area will be left open.
Then local area will be cleaned with sterilized gauze pin second point Agnikarma will be done by conduction method with the help of panchadhatu shalaka
)
| | 2 | Comparator Arm | Procedure | - | agnikarma, अगà¥à¤¨à¤¿à¤•à¤°à¥à¤® | (Procedure Reference: Sushruta samhita, Procedure details: patients examined for the location of the most tenderness point. The tender points will be marked by pen.
The heel region then cleaned with spirit swab.
Agnikarma will be done by conduction method at the point of maximum tenderness with panchadhatu shalaka.
)
|
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with classical clinical features ruja, restricted movements of vatakantaka,Patients irrespective of gender,economical status
|
|
| ExclusionCriteria |
| Details |
Patient suffering from major trauma, having fracture of bone.
K/C/O - Ischemic Heart disease, Gout, rheumatoid arthritis, uncontrolled Diabetes mellitus, Pregnancy.
|
|
|
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 Pain and Restricted Movement will be
assessed on 7th, 14th and 21st day after
intervention |
Improvement in Pain and Restricted Movement will be
assessed on 7th, 14th and 21st day after
intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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)
|
10/12/2024 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Now a days, ever changing lifestyle, improper and professionally adopted postures, food habits & travelling etc. people are facing many physical and mental disorders. Pain is one of them. Heel pain is most commonly found in society which experiences severe pain, restricted foot movements.The results of Agnikarma with Panchadhatu shalaka in the management of vatkantaka has been proven. But both Agnikarma and Viddhakarma at maximum tenderness points has instant pain relieving actions by releasing Vatavarodha and allowing normal Gati of Vata, Pitta, Kapha and Rakta at the site. Agnikarma and Viddhakarma are least invasive procedures described in Ayurveda for treating Vatkantaka. So, the study to evaluate add on effect of Viddhakarma along with Agnikarma in Vatkantaka has been selected. |