| CTRI Number |
CTRI/2022/05/042812 [Registered on: 25/05/2022] Trial Registered Prospectively |
| Last Modified On: |
20/05/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological
Ayurveda
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study of the effect of agnikarm and autologous or own whole blood injection in heel pain |
|
Scientific Title of Study
|
A Randomized Clinical Trail On Agnikarm And Autologous Whole Blood Injection In The Management Of Padkantaka With Special Reference To Planter Fasciitis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Manorma singh |
| Designation |
Lecturer |
| Affiliation |
National institute of ayurveda deemed to be university De novo |
| Address |
PG Department of shalya tantra
National institute of ayurveda deemed to be university(Denovo)
Jorawar singh gate Amer road Jaipur Rajastha 302002
Jaipur
RAJASTHAN
302002
India |
| Phone |
7414810997 |
| Fax |
|
| Email |
docmanorma@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manorma singh |
| Designation |
Lecturer |
| Affiliation |
National institute of ayurveda deemed to be university De novo |
| Address |
PG Department of shalya tantra
National institute of ayurveda deemed to be university(Denovo)
Jorawar singh gate Amer road Jaipur Rajastha 302002
RAJASTHAN
302002
India |
| Phone |
7414810997 |
| Fax |
|
| Email |
docmanorma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manorma singh |
| Designation |
Lecturer |
| Affiliation |
National institute of ayurveda deemed to be university De novo |
| Address |
PG Department of shalya tantra
National institute of ayurveda deemed to be university(Denovo)
Jorawar singh gate Amer road Jaipur Rajastha 302002
RAJASTHAN
302002
India |
| Phone |
7414810997 |
| Fax |
|
| Email |
docmanorma@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute Of Ayurveda |
|
|
Primary Sponsor
|
| Name |
national institute of ayurveda deemed to be novo |
| Address |
national institute of ayurveda deemed to be university(De novo)jorawar sigh gat amer road rajasthan 302002 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Pawan Kumar |
National Institute Of Ayurveda |
department of Shalya tantra/opd block /opd number 32
Jaipur
RAJASTHAN |
9179783979
drpawanmisrapk.pm@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M958||Other specified acquired deformities of musculoskeletal system. Ayurveda Condition: VATAKANTAKAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Autolgous Whole Blood Injection | These patients will be managed with administration of single injection of Autologous whole
blood around the most tender site
Position of the Patients Patient will be placed in supine position with affected limb
inflexion at hip and knee, limb externally rotated so that medial plantar surface is exposed
and most tender site will be marked
Part Preparation The skin will be painted with betadine followed by sprit solution and
sterile drape will be applied. The superficial skin will be inf | | 2 | Intervention Arm | Procedure | - | agnikarma, अगà¥à¤¨à¤¿à¤•à¤°à¥à¤® | (Procedure Reference: sushrut samhita chi/4/8, Procedure details: Clinical Trial duration 3 weeks
ï‚· Follow up 2 follow up of at an interval of 15 days
Purvakarma Patients will be placed in supine position with affected limb inflexion at
hip and knee, limb externally rotated so that medial plantar surface is exposed. The
tender points will be marked and skin will be cleaned with distilled water.
ï‚· Pradhankarma 6 Bindu type of Agnikarma will be done in a rosset pattern using
Tamra Shalaka after heating it to red hot till Samyak Twak Dagdha Lakshana )
|
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 Age 30 to 60 years of either sex .religion etc.
2 Patients presenting with the clinical feature of Padkantaka |
|
| ExclusionCriteria |
| Details |
A Patients having open surgical procedure of plantar fascia
B Patients having fracture of calcaneum ,traumatic pain
C Patients having malignancy of plantar region
D Patients having anatomical defect and congenital structural defect of plantar region.
E Patients having systemic ailments like diabetes mellitus ,hypertension and feature of peripheral neuropathy etc. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Provides relief in the sign and symptoms of padkantaka |
4 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improves the quality of life of patient of Padakantaka |
4 week |
|
|
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/06/2022 |
| 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="0"
Months="0"
Days="21" |
|
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
|
Plantar fasciitis accounts
for about 10-15% of all foot symptoms
requiring professional care. Plantar fasciitis
is a commonly encountered poorly understood orthopedic complaint related to foot, associated with significant morbidity, requiring professional care., A significant number of patients having
plantar fasciitis visit NIA Hospital daily. Even after adequate management,
recurrences are common. As far as contemporary science is concerned till date
no single remedy is available that can provide permanent relief. This study is
proposed with a view to explore a better treatment modality to provide safe, effective,
economic and long-lasting relief to the patient. AIM To evaluate and compare the efficacy of Agnikarma with Tamra Shalaka and local
injection of Autologous whole blood in the management of Padakantaka (Plantar
Fasciitis). OBJECTIVES To evaluate the acceptability and tolerability of Agnikarma with Tamra Shalaka and
Autologous whole blood injection in the patients of Padakantaka (Plantar Fasciitis) Null Hypothesis (H0) – There is no difference between effect of Agnikarma with Tamra
Shalaka and Autologous whole blood injection in the management of Padakantaka with
special reference to Plantar Fasciitis
|