| CTRI Number |
CTRI/2024/07/070259 [Registered on: 09/07/2024] Trial Registered Prospectively |
| Last Modified On: |
24/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Ayurveda
Other (Specify) [Snigdha and Ruksha Agnikarma] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study to see the effect of Kshaudra agnikarma over Panchalohashalaka agnikarma in the treatment of heel pain |
|
Scientific Title of Study
|
A Randomized Comparative Clinical Study to evaluate the effect of Kshaudra agnikarma over Panchalohashalaka agnikarma in the management of 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 Pooja Kalburgi |
| Designation |
PG Scholar |
| Affiliation |
BLDEAS AVS Ayurveda Mahavidyalaya Hospital and Research Centre, Vijayapura |
| Address |
Department of Shalyatantra, BLDEAS AVS Ayurveda Mahavidyalaya Hospital and Research Centre, Bagalkot road, Vidya Nagar, Murankeri,Vijayapura,
Karnataka
586109
India
Bijapur
KARNATAKA
586109
India |
| Phone |
7204684349 |
| Fax |
|
| Email |
Poojakalburgi1956@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aneesur Rehman M Madni |
| Designation |
Assosiate Professor |
| Affiliation |
BLDEAS AVS Ayurveda Mahavidyalaya Hospital and Research Centre, Vijayapura |
| Address |
Department of Shalyatantra, BLDEAS AVS Ayurveda Mahavidyalaya Hospital and Research Centre, Bagalkot road, Vidya Nagar, Murankeri,Vijayapura,
Karnataka
586109
India
Bijapur
KARNATAKA
586109
India |
| Phone |
9538140448 |
| Fax |
|
| Email |
anees8804@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aneesur Rehman M Madni |
| Designation |
Assosiate Professor |
| Affiliation |
BLDEAS AVS Ayurveda Mahavidyalaya Hospital and Research Centre, Vijayapura |
| Address |
Department of Shalyatantra, BLDEAS AVS Ayurveda Mahavidyalaya Hospital and Research Centre, Bagalkot road, Vidya Nagar, Murankeri,Vijayapura,
Karnataka
586109
India
Bijapur
KARNATAKA
586109
India |
| Phone |
9538140448 |
| Fax |
|
| Email |
anees8804@gmail.com |
|
|
Source of Monetary or Material Support
|
| BLDEAS AVS Ayurveda Mahavidyalaya Hospital and Research centre, Bagalkot road,Vidya Nagar,Murankeri,Vijayapura,
586109
Karnataka,India |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 Pooja kalburgi |
BLDES AVS Ayurveda Mahavidyalaya Hospital and Research Centre,Vijayapura |
Department of Shalya tantra, OPD no.3, BLDEAS AVS Ayurveda Mahavidyalaya Hospital and Research Centre, Bagalkot road, Vidya Nagar, Murankeri,Vijayapura, Karnataka
Bijapur
KARNATAKA |
7204684349
Poojakalburgi1956@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical committee BLDEAS AVS Ayurveda Mahavidyalaya Hospital and research centre |
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 | Intervention Arm | Procedure | - | agnikarma, अगà¥à¤¨à¤¿à¤•à¤°à¥à¤® | (Procedure Reference: Sushruta Samhita of Sushruta with the Nibandha sangraha and Nyayachandrika commentary edited by Vaidya Jadavji Trikamji Acharya, Chaukambha publications, New delhi, Sutra sthana, adhyaya 12, shloka no. 4, Procedure details: Agnikarma will be done with tapta kshaudra is applied at marked tender areas in circular patch form with a spatula and left at the site till it cools on its own.)
| | 2 | Comparator Arm | Procedure | - | agnikarma, अगà¥à¤¨à¤¿à¤•à¤°à¥à¤® | (Procedure Reference: Sushruta Samhita of Sushruta with the Nibandha sangraha and Nyayachandrika commentary edited by Vaidya Jadavji Trikamji Acharya, Chaukambha publications, New delhi, Sutra sthana, adhyaya 12, shloka no. 4, Procedure details: Agnikarma will be performed with tapta Panchaloha Shalaka at most tender marked points in bindu form.)
|
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1) Patient with lakshanas of Vatakantaka viz., shoola, stambha, sparshasahatva at heel
region.
2) Patients will be selected irrespective of gender, religion, socio economic status and
occupation.
3) Patients will be selected from age group of 16 to 70 years. |
|
| ExclusionCriteria |
| Details |
1) Fracture of calcaneum, ankle sprain, soft tissue injury are excluded.
2)Vascular diseases of lower extremities, and other neurological disorders.
3) Paget’s disease of the calcaneum.
4) Uncontrolled diabetes mellitus.
5) Pitta prakruti. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To reduce the pain and tenderness |
41 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To prevent the reoccurance of pain |
41 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 |
|
Date of First Enrollment (India)
|
15/07/2024 |
| 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="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
This study is Randomized Comparative clinical study to evaluate the effect of Kshaudra agnikarma over Panchalohashalaka agnikarma in the management of Vatakantaka that will be conducted in BLDEA’S AVS Ayurveda Mahavidyalaya Hospital and Research Centre, Vijayapur-585109, Karnataka, India |