| CTRI Number |
CTRI/2025/03/082586 [Registered on: 18/03/2025] Trial Registered Prospectively |
| Last Modified On: |
18/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Other (Specify) [excision with agnikarma/ dahankarma] |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Application of sneha dahan and lauha shalaka dahan after excision of corn. |
|
Scientific Title of Study
|
A comparative clinical study of sneha dagdha and lauha shalaka dagdha after chhedana karma of kadara w.s.r.to Corn |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sunidhi Bara |
| Designation |
P.G. scholar |
| Affiliation |
Shri NPA Government Ayurved College Raipur Chhattisgarh |
| Address |
OPD no. 15 Department of Shalya tantra Shri khudadad Dungaji Govt. Ayurved Hospital Raipur Chhattisgarh Shri NPA Government Ayurved College Raipur Chhattisgarh
Raipur
CHHATTISGARH
492010
India |
| Phone |
9644137126 |
| Fax |
|
| Email |
sunidhi07765@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Satrupa Nirmal |
| Designation |
Lecturer Shalya Tantra |
| Affiliation |
Shri NPA Government Ayurved College Raipur Chhattisgarh |
| Address |
OPD no. 15 Department of Shalya tantra Shri khudadad Dungaji Govt. Ayurved Hospital Raipur Chhattisgarh Shri NPA Government Ayurved College Raipur Chhattisgarh
Raipur
CHHATTISGARH
492010
India |
| Phone |
9301088046 |
| Fax |
|
| Email |
rupa.nirmal1985@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Uttam Kumar Nirmalkar |
| Designation |
Reader Shalya Tantra |
| Affiliation |
Shri NPA Government Ayurved College Raipur Chhattisgarh |
| Address |
OPD no. 15 Department of Shalya tantra Shri khudadad Dungaji Govt. Ayurved Hospital Raipur Chhattisgarh Shri NPA Government Ayurved College Raipur Chhattisgarh
Raipur
CHHATTISGARH
492010
India |
| Phone |
8234057199 |
| Fax |
|
| Email |
druk01508@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri NPA Government Ayurved College Raipur Chhattisgarh India
Raipur 492010 |
|
|
Primary Sponsor
|
| Name |
Shri NPA Government Ayurved College Raipur Chhattisgarh |
| Address |
Shri NPA Government Ayurved College Raipur Chhattisgarh India
Raipur 492010 |
| Type of Sponsor |
Other [Shri NPA Government Ayurved College Raipur Chhattisgarh] |
|
|
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 Sunidhi Bara |
Shri khudadad Dungaji Ayurved Hospital Raipur |
OPD no. 15 Department of Shalya tantra Government Hospital Raipur Chhattisgarh 492010 Raipur Chhattisgarh
Raipur
CHHATTISGARH |
9644137126
sunidhi07765@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:L84||Corns and callosities. Ayurveda Condition: KADARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | agnikarma, अग्निकर्म | (Procedure Reference: Sushrut Samhita Chikitsa Sthan 20/23, Procedure details: The procedure will be divided in to 3 steps
1) Poorvakarma - It includes preparation in relation to the patient & procedure Explain the patient about the procedure,
Instruments preparation,
Written consent,
Inj. TT 0.5ml IM for sensitivity,
Inj. Lignocaine 0.3ml ID for sensitivity.
investigation.
Pradhan karma - CHHEDANA KARMA- The patient will be asked to lie down on the operation table,
The operative part will be cleaned with aseptic solutions & drape it with sterile cut drape sheet,
Local infiltration anaesthesia of 3 to 5 ml of 2% Lignocaine in surrounding area of corn will be given,
Surgical blade no. 15 (Vridhhi Patra) put into BP handle & complete corn will be excised in shape of a conical hard tissue,
SNEHA DAGDHA:- For Sneha Dagdha Tila Taila will be heated up to its smoking point then some small cotton ball will be put in hot Tila taila & then cotton ball will be kept on excised corn wound by pressing a little for 2-5 second. This procedure will be repeated untill Samyaka Dagdha Lakshna appeared. (eg. Krishanonnatavranta sirasannirodhasch)
Pashchat karma – Proper Antiseptic dressing of the wound will be done followed by bandaging,
Patient will be advised to avoid contact of water at least for 2 days,
The condition of the wound will be keenly observed in each follow up visit.)
| | 2 | Comparator Arm | Procedure | - | agnikarma, अग्निकर्म | (Procedure Reference: Sushrut Samhita Chikitsa Sthan 20/23, Procedure details: 1) Poorvakarma - It includes preparation in relation to the patient & procedure Explain the patient about the procedure,
Instruments preparation,
Written consent,
Inj. TT 0.5ml IM for sensitivity,
Inj. Lignocaine 0.3ml ID for sensitivity, Investigation,
Pradhan karma - CHHEDANA KARMA-The patient will be asked to lie down on the operation table,
The operative part will be cleaned with aseptic solutions & drape it with sterile cut drape sheet,
Local infiltration anaesthesia of 3 to 5 ml of 2% Lignocaine in surrounding area of corn will be give, Surgical blade no. 15 (Vridhhi Patra) put into BP handle & complete corn will be excised in shape of a conical hard tissue,
LAUHA SHALAKA DAGDHA:- For Lauha Shalaka Dagdha, Lauha Shalaka will be kept on gas burner till red hot & kept it on excised wound of corn tissue with firm pressure for 2-5 second.
This procedure will be repeated untill Samayaka Dagdha Lakshnaappeared,
Pashchat karma –Proper Antiseptic dressing of the wound will be done followed by bandaging,
Patient will be advised to avoid contact of water at least for 2 days,
The condition of the wound will be keenly observed in each follow up visit.)
|
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
The patients who presented with classical signs and symptoms of kadara
2. Patients with controlled diabetic mellitus
3. Patients with controlled hypertension
4. Both rural and urban residents will be consider |
|
| ExclusionCriteria |
| Details |
1. Age below 18 years and above 60 years.
2. Patients with uncontrolled diabetic mellitus and hypertension
3. Patients with known history of malignancy
4. Pregnant ladies
5.Autoimmune disease
6. Tuberculosis
7. Patients with anatomical deformity of legs
8. Infected corn and infection on foot |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To reduce recurrence of kadara |
Recurrence will be monitored up to 3 months after procedure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To relieving other associate symptoms like pain and tenderness |
Recurrence will be monitored up to 3 months after procedure |
|
|
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)
|
01/04/2025 |
| 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="3"
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
|
Kadara is mentioned in Kshudra roga which is described by Acharya Sushruta in Nidan Sthana .In recent era, the corn symptom is similar of Kadara. Corn is a localized hyperkeratosis of the skin. It is usually occur at the site of pressure e.g. on sole and toes. There is usually a horny induration of the cuticle with a hard center. Corn is initially painless but it may be painful particularly when it is rubbed frequently. Corn has tendency to recure after Chhedana Karma (excision) In reference to Chikitsa, of Kadara, Acharya Sushruta and Acharya Dalhana mentioned the seat of the affected lesion should be excised followed by Dahankarma so complete removal of hyperkeratotic mass removed up to the central core, it produces pain relief to the patient due to absence of pressure and after Chhedana Karma of Kadara doing Dahanakarma reduces the chance of recurrence and bleeding. (Referance - sushruta Samhita Chikitsa Sthan 20/23) |