| CTRI Number |
CTRI/2023/03/050261 [Registered on: 02/03/2023] Trial Registered Prospectively |
| Last Modified On: |
28/02/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study Viddha-agnikarma therapy with therapeutic ultrasound for relieving heel pain |
|
Scientific Title of Study
|
A COMPARATIVE CLINICAL STUDY TO ASSESS THE EFFICACY OF VIDDHA-AGNIKARMA WITH THERAPEUTIC ULTRASOUND AT THE SITE OF KURCHASHIRA MARMA IN THE MANAGEMENT OF VATAKANTAKA (PLANTAR FASCIITIS)- A MULTI DISCIPLINARY APPROACH |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR Khushdeep Kaur |
| Designation |
MS Scholar Shalyatantra |
| Affiliation |
DR DY Patil College Of Ayurved And Research Centre Pimpri Pune 411018 |
| Address |
OPD No.3 Shalyatantra Department DR DY Patil college of Ayurved and Research centre Pimpri, Pune Santtukaram nagar Maharashtra India 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
7087227562 |
| Fax |
|
| Email |
khusi496@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Archana Kukade Shinde |
| Designation |
Associate Professor of Shalya Tantra Department |
| Affiliation |
DR DY Patil college of Ayurved and Research centre Pimpri Pune 18 |
| Address |
OPD No.3 Shalyatantra Department DR DY Patil college of Ayurved and Research centre Pimpri, Pune Santtukaram nagar Maharashtra India 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
9423065167 |
| Fax |
|
| Email |
archanakukde@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Archana Kukade Shinde |
| Designation |
Associate Professor of Shalya Tantra Department |
| Affiliation |
DR DY Patil college of Ayurved and Research centre Pimpri Pune 18 |
| Address |
OPD No.3 Shalyatantra Department DR DY Patil college of Ayurved and Research centre Pimpri, Pune Santtukaram nagar Maharashtra India 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
9423065167 |
| Fax |
|
| Email |
archanakukde@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| DR DY PATIL COLLEGE OF AYURVED AND RESEARCH CENTRE, PIMPRI, PUNE-18. |
|
|
Primary Sponsor
|
| Name |
DR KHUSHDEEP KAUR |
| Address |
OPD NO. 3 SHALYA DEPARTMENT DR DY PATIL AYURVED AND RESEARCH CENTRE PIMPRI PUNE 18 |
| Type of Sponsor |
Other [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 KHUSHDEEP KAUR |
DR DY PATIL COLLEGE OF AYURVED AND RESEARCH CENTRE, PIMPRI, PUNE-18 |
OPD NO-3, DR DY PATIL COLLEGE OF AYURVED AND RESEARCH CENTRE, PIMPRI, PUNE-18.
Pune
MAHARASHTRA |
7087227562
khusi496@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RESEARCH AND RECOGNITION COMMITEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M796||Pain in limb, hand, foot, fingersand toes. Ayurveda Condition: VATAKANTAKAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | agnikarma अिfकम.l | (Procedure Reference: Susurat sutra sthan chapter 12, Procedure details: Used Needle of number 26 1½ G and removed needle hub
It will be inserted at about 0.5cm near Kurchashira Marma at plantar surface of foot and later on heat will be applied to needle with lighter.
Heat will be applied for 5-10 seconds or feeling of warmth at affected site.
18 patients diagnosed as VATAKANTAKA (Plantar fasciitis)
will be treated with Viddha Agni Karma on 0th & 4th day
)
| | 2 | Comparator Arm (Non Ayurveda) | | - | THERAPEUTIC ULTRASOUND (PHYSIOTHERAPY) | Medico’s Ultrasound transmission Gel apply between ultrasound cap and skin during the applications for ensuring conductivity
Mode : Countinous, Circular motion
Frequency :3MHz
Power Density :1W/cm2
Duration of the procedure: 8min
Area of application Kurchashira Marma at plantar surface of foot.
Group B: 18 patients diagnosed as VATAKANTAKA (Plantar fasciitis)
will be treated with
Therapeutic Ultrasound daily for 7 day
|
|
| Comparator Agent |
THERAPEUTIC ULTRASOUND |
THERAPEUTIC ULTRASOUND will be done for 7 days
Follow ups will be on 4th and 7th day
Total duration of study will be 7days |
| Intervention |
VIDDHA AGNIKARMA |
VIDDHA AGNIKARMA will be done on 0th and 4th day
Follow ups will be on 4th and 7th day
Total duration of study will be 7days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients having sign and symptoms at the site of Plantar Fasciitis such as:
1) Pain
2) Tenderness
3) Morning stiffness
4) Unable to bear body weight on the affected leg
5) Calcaneal spur |
|
| ExclusionCriteria |
| Details |
K/c/o
1) Peripheral vascular disease
2) Diabetes Mellitus/ Diabetic Neuropathy
3) Lymphedema
4) Dislocation & fracture of ankle joint
5) Ulcers such as Varicose ulcer, trophic ulcers
6) Patient on blood thinners. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the effect of Viddha- Agnikarma at the site of kurcha shira marma for relieving pain in Vatakantaka(Plantar Fasciitis). |
Viddha Agnikarma will be done on Oth and 4th day
Therapeutic Ultrasound will be done daily for 7days
Follow ups will be on 4th and 7th day
Total Duration of study will be 7days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To observe the adverse affects of Viddha Agnikarma at site of Kurcha Shira Marma, |
Viddha Agnikarma will be done on Oth & 4th day
Therapeutic Ultrasound will be done on daily for 7days
Follow ups will be on 4th & 7th day
Total Duration of study will be 7 days |
|
|
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/ Phase 3 |
|
Date of First Enrollment (India)
|
06/03/2023 |
| 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
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a comparative clinical study to assess the efficacy of Viddha agnikarma with therapeutic ultrasound at the site of Kurchashira Marma for relieving pain in the Vatakantaka (Plantar fasciitis) Viddha-Agnikarma will be done on 0th & 4th day. Therapeutic Ultrasound will be done on daily for 7days.Follow ups will be on 4th & 7th day. Total Duration of study will be 7 days.The age group taken for the study trail will be between 18 years and upto 60 years |