| CTRI Number |
CTRI/2019/10/021515 [Registered on: 03/10/2019] Trial Registered Prospectively |
| Last Modified On: |
25/03/2020 |
| 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
|
Treatment of heel pain using Agnikarma and Ultrasound Therapy |
|
Scientific Title of Study
|
A Comparative Clinical Trial On Agnikarma And Ultrasound Therapy In The Pain Management Of Vatakantaka W S R To Calcaneal Spur. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrNibedita Panda |
| Designation |
PG Scholar |
| Affiliation |
SJG Ayurvedic Medical College. |
| Address |
Room No- 4, Dept. Panchakarma,SJG Ayu.Medical College,Gavimath Campus,Koppal,
Koppal
KARNATAKA
583231
India |
| Phone |
9438181855 |
| Fax |
|
| Email |
dr.nibeditap21@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrSuresh Hakkandi |
| Designation |
professor and HOD |
| Affiliation |
SJG AYURVEDIC MEDICAL COLLEGE |
| Address |
Room No- 4, SJG Ayurvedic Medical College, GAVIMATH CAMPUS,KOPPAL.
Koppal
KARNATAKA
583231
India |
| Phone |
9448609362 |
| Fax |
|
| Email |
sureshhakkandi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrSuresh Hakkandi |
| Designation |
professor and HOD |
| Affiliation |
SJG AYURVEDIC MEDICAL COLLEGE |
| Address |
Room No- 4, SJS Ayu. Medical college, GAVIMATH CAMPUS,KOPPAL.
Koppal
KARNATAKA
583231
India |
| Phone |
9448609362 |
| Fax |
|
| Email |
sureshhakkandi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr.Nibedita panda
department of panchakarma
SJG ayurvedic medical college
koppal , karnataka 583231 |
|
|
Primary Sponsor
|
| Name |
Department of panchakarma |
| Address |
Room no 4
SJG ayurvedic medical college
gavimutt campus
koppal |
| 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 |
| DrNibedita Panda |
SJG Ayurvedic Medical College |
Room No. 4, DepT. panchakarma
Gavimath campus,
Koppal
KARNATAKA |
9438181855
dr.nibeditap21@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutuinal clinical ethics comittee |
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, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
agnikarma |
patient is subjected to agnikarma for 3 days on day 1 day 4 day 7 |
| Comparator Agent |
ultrasound |
ultrasound is given for 7 days of 15 mins each sitting |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.The patients presenting the classical features of Vatakantaka.
2.Age group between 25-65 years of either sex.
3.Patients fit for Agnikarma and ultra sound Therapy
|
|
| ExclusionCriteria |
| Details |
1.Patients suffering from fractures and dislocation of Ankle joint, Post Traumatic Ankylosis, Rheumatoid Arthritis, Gouty Arthritis and any other Orthopedic Disorder causing pain in the Sole of the Foot.
2.Patient suffering from other systemic disorders.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Decrease in pain and tenderness of the heel &Improvement in walking. |
FOLLOW UP AFTER 14 DAYS OF 3 SITTINGS OF AGNIKARMA AND 14 DAYS AFTER 7 DAYS OF ULTRASOUND THERAPY |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| complete absence of the heel pain and improvement in the lifestyle of the patient |
after 21 days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
10/10/2019 |
| Date of Study Completion (India) |
27/02/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="7"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
it is a comparative clinical trial on agnikarma and
ultrasound therapy in the pain management of vatakantaka w s r to calcaneal
spur.
Agnikarma was done on day 1, 4 and on day 7.
Ultra sound therapy was done for 7 consecutive days.
The subjective and objective parameters were
collected on the respective days and the collected data were assessed
using wilcoxon
sign rank test and the man whitney u test within the
group and between the groups respectively to analyse the significance of the therapies.
Agnikarma
and ultrasound therapy both shown good results in relieving the symptoms.
However, agnikarma was found to be statistically more effective on pain
management in vatakantaka
|