| CTRI Number |
CTRI/2024/08/072167 [Registered on: 08/08/2024] Trial Registered Prospectively |
| Last Modified On: |
24/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Clinical Trial To Find Out How Effective Suvarna shalaka Agnikarma Is In Vatakantaka. |
|
Scientific Title of Study
|
A Randomised Controlled Clinical Trial To Study The Effect Of Suvarna shalaka Agnikarma In Vatakantaka With Special Reference 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 Pranjali Sanjay Narwade |
| Designation |
PG Student |
| Affiliation |
SMBT Ayurved College And Hospital |
| Address |
Department Of Shalyatantra SMBT Ayurved College And Hospital Dhamangaon Nashik
Nashik
MAHARASHTRA
422403
India |
| Phone |
8766894571 |
| Fax |
|
| Email |
pranjalnarwade123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shilpa Premchand Badhe |
| Designation |
Professor |
| Affiliation |
SMBT Ayurved College And Hospital Dhamangaon Igatpuri Nashik |
| Address |
Department Of Shalyatantra SMBT Ayurved College And Hospital Dhamangaon Tal- Igatpuri Dist- Nashik Maharashtra 422403 India
Nashik
MAHARASHTRA
422403
India |
| Phone |
9689339928 |
| Fax |
|
| Email |
adkpc74@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pranjali Sanjay Narwade |
| Designation |
PG Student |
| Affiliation |
SMBT Ayurved College And Hospital |
| Address |
Department Of Shalyatantra SMBT Ayurved College And Hospital Dhamangaon Nashik
Nashik
MAHARASHTRA
422403
India |
| Phone |
8766894571 |
| Fax |
|
| Email |
pranjalnarwade123@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Shalyatantra, SMBT Ayurved College and Hospital, Dhamangaon, Nashik, Maharashtra 422403 India |
|
|
Primary Sponsor
|
| Name |
Dr Pranjali Sanjay Narwade |
| Address |
Department of Shalyatantra SMBT Ayurved College And Hospital Dhamangaon Igatpuri, Nashik Maharashtra, 422403, India |
| Type of Sponsor |
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 Pranjali Sanjay Narwade |
SMBT Ayurved College And Hospital |
Department of Shalyatantra OPD No 3, Dhmangaon, Nashik Maharashtra 422403, India
Nashik
MAHARASHTRA |
8766894571
pranjalnarwade123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMBT Ayurved College And Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M722||Plantar fascial fibromatosis. Ayurveda Condition: VATAKANTAKAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | agnikarma, अगà¥à¤¨à¤¿à¤•à¤°à¥à¤® | (Procedure Reference: Sushruta samhita sutrasthan Adhyay 12, Procedure details: PURVA KARMA
1) Take consent for the procedure and evaluate patient safety for before procedure.
2) Prepare ghreet kumari majja
3) Area demarcation for Agnikarmashould be done.
4) Heat the suvarna Shalaka up to red hot
PRADHANA KARMA
1) Painting of demarcated area for Agnikarma with antiseptic solution.
2) Drapping with sterile linen hole sheet to expose only operative area.
3) Agnikarma with suvarna Shalaka with BinduDagdga method leaving 0.5 cm – 1cm gap between two points of Dagdha
4) Immediate GhreetaKumariMajja application.
PASHCHAT KARMA
1) After the agnikarma has been done in the proper manner,the area ( of burning) should be anointed with mixture of honey and ghee .
2) Advice to avoid water contact to DagdhaVrana area for next 24 hours.
3) Post procedure evaluation should be written in patient’s file)
|
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)Diagnose patients with classical features of VATAKANTAKA i.e. – Ruk ,
vedana
2)Patients of age group 40-60 years irrespective of religion and caste. |
|
| ExclusionCriteria |
| Details |
1)Patients with known case of uncontrolled diabetes, hypertension,
cardiac disease, CA, TB
2)Local skin disease at agnikarma site.
3)Calcaneal stress fracture.
4)Anarha’s of agnikarma mentioned of classics. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in Sign and Symptoms of Vatkantaka after Agnikarma With Suvarnashalaka |
10 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Where the trial group stands in comparison with control group. |
18 months |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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 3 |
|
Date of First Enrollment (India)
|
16/08/2024 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| 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
|
In today’s world, an increase in heel problems is due to changes in lifestyle like professional requirements, trendy fashions etc. Modern medicine has treatments like NSAID’S , local steroids and surgery for Plantar fasciitis. Although steroid injections can relieve pain, it is only temporary. However, prolonged use of NSAID’S can cause Ill effects such as gastritis etc. Ayurveda provides many options for pain management and among them Agnikarma is most effective. It is simple and easy procedure that can be done at an OPD level. Conducting research to evaluate effect of suvarna shalaka Agnikarma in Vatakantaka is crucial for expanding our understanding of traditional remedies and their applications in modern healthcare. By filling the knowledge gap, the study can provide valuable insights into potential effects of Agnikarma in Vatakantaka. Including patients within age group of 40-60 years, who fullfill clinical diagnostic criteria for Plantar fasciitis. Patients are selected irrespective of sex, socio economic status and community helps in achieving a disease and representative sample, enhancing the generalizability of the study findings, written consent from patients ensures ethical compliance and transparency in the treatment process. SAMPLE SIZE using formula by Daniel 1999, the calculated sample size is 35. Simple random technique will be used. Total 70 number of patients will be selected and divided into two groups named as Group A (trial group) and Group B (control group). Suvarna shalaka Agnikarma (group A) and Mruttika shalaka Agnikarma (group B) will be given to patients. Both shalaka Agnikarma will be done on 1st , 3rd , 5th, and 7th day. All SOP of Agnikarma will be strictly followed during and after the procedure. Observations will be done after procedure and follow-up after treatment is on 10th day. Result of study will drawn on the basis of criteria of assessment and statistical analysis. Discussion will be done on the basis of observations and result obtained during treatment. Summary will be drawn and whole thesis work will be summarised. Conclusion will be drawn strictly on the basis of statistical analysis and will be unbised |