| CTRI Number |
CTRI/2024/09/074266 [Registered on: 24/09/2024] Trial Registered Prospectively |
| Last Modified On: |
18/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Ayurvedic management of heel pain |
|
Scientific Title of Study
|
A Clinical Study To Evaluate the effect Of Agnikarma Using Tamrashalaka In The Management of Vatakantaka W. S. R to 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 Madhura N |
| Designation |
PG Scholar |
| Affiliation |
Shri Dharmasthala Manjunatheshwara college of Ayurveda kuthpady Udupi ayurveda |
| Address |
Department Of PG studies in Shalyatantra OPD 5 Shri Dharmasthala Manjunatheshwara College Of ayurveda Kuthpady Udupi karnataka
Udupi
KARNATAKA
574118
India |
| Phone |
7349137750 |
| Fax |
|
| Email |
madhuranataraj97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajneesh V Giri |
| Designation |
HOD |
| Affiliation |
Shri Dharmasthala Manjunatheshwara college of Ayurveda Kuthpady Udupi |
| Address |
Department of PG studies in Shalyatantra OPD 5 Shri Dharmasthala Manjunatheshwara College Of ayurveda Kuthpady Udupi karnataka
Udupi
KARNATAKA
574118
India |
| Phone |
9845407543 |
| Fax |
|
| Email |
drrajneeshgiri@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajneesh V GIri |
| Designation |
HOD |
| Affiliation |
Shri Dharmasthala Manjunatheshwara college of Ayurveda Kuthpady Udupi |
| Address |
Department of PG studies in Shalyatantra OPD 5 Shri Dharmasthala Manjunatheshwara College Of ayurveda Kuthpady Udupi karnataka
Udupi
KARNATAKA
574118
India |
| Phone |
9845407543 |
| Fax |
|
| Email |
drrajneeshgiri@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Dharmasthala Manjunatheshwara Ayurveda college and Hospital Kuthpady Udupi Karnataka Pin code 574118 |
|
|
Primary Sponsor
|
| Name |
Shri Dharmasthala Manjunatheshwara college of Ayurveda |
| Address |
SDM college of Ayurveda and Hospital Kuthpady Udupi Karnataka pin code 574118 |
| 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 |
| Dr Madhura N |
Shri Dharmasthala Manjunatheshwara Ayurveda Hospital |
Department of Shalyatantra OPD 5 Kuthpady Udupi 574118
Udupi
KARNATAKA |
7349137750
madhuranataraj97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC SDM college of Ayurveda Kuthpady Udupi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
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
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | agnikarma, अगà¥à¤¨à¤¿à¤•à¤°à¥à¤® | (Procedure Reference: Sushruta samhita sutrasthana 12th chapter, Procedure details: Red hot Shalaka is placed on the tender points of the heel here Bindu pattern of Agnikarma is adopted frequency is one sitting On 1st day 7th day & 14th day only Total duration is 14 days )
|
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Pain in plantar aspect of heel
Pain on keeping first few steps in the morning
Stiffness |
|
| ExclusionCriteria |
| Details |
Patients below 18 years and above 60 years
Bleeding disorders
Uncontrolled diabetes mellitus
Pregnancy
Calcaneal spur |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To find the effect of agnikarma by Tamrashalaka in reducing the pain over the plantar aspect of heel |
Effect of the procedure will be assessed on 7th day and 14th day That is within 2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Time taken for reducing the pain in heel |
14 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)
|
18/10/2024 |
| 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
|
Plantar fasciitis is the most common cause of chronic heel pain in adults affecting young active patients and older sedentary individuals It is estimated that 1 in 10 people will develop heel pain during their lifetime Incidence occurs between 40 and 60 years of age Vatakantaka is mainly Vyadhi of vitiated Vata Dosha aggarvated vata because of exertion walking on an irregular surface as well as due to improper placement of foot over the ground takes Ashraya in the Gulfa sandhi causes pain in Padatala pradesha Agnikarma is the best management of decreasing pain hence this study is taken to evaluate the effect of Agnikarma using Tamrashalaka |