| CTRI Number |
CTRI/2021/07/034596 [Registered on: 05/07/2021] Trial Registered Prospectively |
| Last Modified On: |
02/07/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Agnikarma in Vatakantaka or Planter Fasciitis patients |
|
Scientific Title of Study
|
A Comparative study of Agnikarma and Heat therapy in the management of Vatakantaka w.s.rto 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 Neha chelak |
| Designation |
PG scholar |
| Affiliation |
Shri Narayan Prasad Awasthi Govt Ayurved College Raipur Chattisgarh |
| Address |
Shri Narayan Prasad Awasthi Govt Ayurved College Raipur Chattisgarh INDIA
Raipur
CHHATTISGARH
492010
India |
| Phone |
7974088894 |
| Fax |
|
| Email |
nehachelak8214@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Uttam Kumar Nirmalkar |
| Designation |
Lecturer shalya tantra |
| Affiliation |
Shri Narayan Prasad Awasthi Govt Ayurved college Raipur Chattisgarh |
| Address |
OPD no 15 Dept of Shalya Tantra Shri Narayan Prasad Awasthi Govt Ayurved college Raipur Chattisgarh
Raipur
CHHATTISGARH
492010
India |
| Phone |
8234057199 |
| Fax |
|
| Email |
druk01508@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Balendra Singh |
| Designation |
Reader shalya tantra |
| Affiliation |
Shri Narayan Prasad Awasthi Govt Ayurved College Raipur Chattisgarh |
| Address |
OPD no 15 Dept of Shalya Tantra Shri Narayan Prasad Awasthi Govt Ayurved college Raipur Chattisgarh
Raipur
CHHATTISGARH
492010
India |
| Phone |
9039180335 |
| Fax |
|
| Email |
drbalendrasingh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Narayan Prasad Awasthi Govt Ayurved college Raipur CG INDIA |
|
|
Primary Sponsor
|
| Name |
Shri Narayan Prasad Awasthi Govt Ayurved college Raipur Chattisgarh |
| Address |
Shri Narayan Prasad Awasthi Govt Ayurved college Raipur Chattisgarh |
| Type of Sponsor |
Other [Shri Narayan Prasad Awasthi Govt Ayurved college Raipur Chattisgarh INDIA] |
|
|
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 NEHA CHELAK |
SHRI KHUDADAD DOONGAJI GOVT AYURVED HOSPITAL |
OPD no 15
Dept of Shalya Tantra
Govt Ayurved Hospital Raipur Chattisgarh INDIA
Raipur
CHHATTISGARH |
7974088894
nehachelak8214@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:M708||Other soft tissue disorders related to use, overuse and pressure. Ayurveda Condition: VATAKANTAKAM, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Agnikarma local application at most tender point |
Agnikarma with red hot pancha dhatu shalaka local application at most tender point as bindu dehen vishesh 5 sitting at the interval of 7 days duration of therapy will be of 35 days |
| Comparator Agent |
Hydrocollator heat therapy |
Hydrocollator silicon gelpacks or bentonite crystal packs are heated in hydrocollator unit for 30 to 40 min then the pack is Applied to the body as local application after being wrapped in toweling for 5 to 10 minutes |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient of age group 18 to 60 yrs
Patients of either sex will be selected
Patients having classical sign and symptom of Vatakantaka. |
|
| ExclusionCriteria |
| Details |
Severe anaemic patient, malnourish patient, haemophilia, patient with septicemia, osteomyelitis, calcaneal tumour, bursitis, below ankle fracture, AIDS,T.B, uncontrolled Diabetes mellitus, hepatitis-B, malignancy, varicose veins, Deep vein thrombosis, arterial ulcer, neurogenic ulcer, leprosy, pregnancy, acute & chronic renal failure, jaundice & cirrhosis of liver |
|
|
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 |
Relief from pain
Relief from tenderness
|
35 Days
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Relief from restricted movement , pain and tenderness disappear |
35 Days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
20/07/2021 |
| 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
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Ayurveda is the science of life derived from its ancient sanskrit root ayus and veda and offering rich comprehensive outlook to a healthy life. Vatadritey nastiruja Acharya Sushruta mention that there is no pain without vata dosha and such disease treatment should be treated with vataghnachikitsa raktaavasechanam eranda tailam medicinal compound oleation poultice agnikarma bandaging massage up to considerable relief from pain. Agnikarma is classified as Agni krita karma or the karma or action carried out by agnikarma |