CTRI

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CTRI Number

CTRI/2021/07/035141 [Registered on: 26/07/2021] Trial Registered Prospectively

Last Modified On:

19/07/2021

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Ayurveda

Study Design

Randomized, Parallel Group Trial

Public Title of Study

To compare the effect of Therapeutic Burn using Shalaka(Dry burn) and Thailam(Moist burn) in Kadara(Corn)

Scientific Title of Study

A Randomized Comparative Clinical Trial to evaluate the effect of Shalakadahana and Thailadahana after Chedana Karma in the management of Kadara w.s.r. to Corn

Trial Acronym

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr Mayookha Madhusudanan
Designation	PG Scholar
Affiliation	Sri Jayendra Saraswathi Ayurveda College and Hospital
Address	Deptartment of Shalya Tantra, OP Room no 8, Sri Jayendra Saraswathi Ayurveda College and Hospital, Nazarathpet, Chennai Sri Jayendra Saraswathi Ayurveda College and Hospital, Nazarathpet, Chennai-123 Chennai TAMIL NADU 600123 India
Phone	9994382839
Fax
Email	mayookha.madhu@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Anita Patel
Designation	Reader
Affiliation	Sri Jayendra Saraswathi Ayurveda College and Hospital
Address	Department of Shalya Tantra, OP room no 8, Sri Jayendra Saraswathi Ayurvdeda College and Hospital, Nazarathpet, Chennai Sri Jayendra Saraswathi Ayurveda College and Hospital, Nazarathpet, Chennai 600123 Chennai TAMIL NADU 600123 India
Phone
Fax
Email	dranitasudha@gmail.com

Details of Contact Person
Public Query

Name	Dr Mayookha Madhusudanan
Designation	PG Scholar
Affiliation	Sri Jayendra Saraswathi Ayurveda College and Hospital
Address	Department of Shalya Tantra, OP Room no 8, Sri Jayendra Saraswathi Ayurvdeda College and Hospital, Nazarathpet, Chennai Sri Jayendra Saraswathi Ayurvdeda College and Hospital, Nazarathpet, Chennai 600123 Chennai TAMIL NADU 600123 India
Phone
Fax
Email	mayookha.madhu@gmail.com

Source of Monetary or Material Support

Sri Jayendra Saraswathi Ayurveda College and Hospital, Nazarathpet, Chennai 600123

Primary Sponsor

Name	Dr Mayookha Madhusudanan
Address	Sri Jayendra Saraswathi Ayurveda College and Hospital, Nazarathpet, Chennai 600123
Type of Sponsor	Other [Self]

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Mayookha Madhusudanan	Sri Jayendra Saraswathi Ayurveda College and Hospital	Department of Shalya Tantra, OP Room no 8, Sri Jayendra Saraswathi Ayurveda College and Hospital, nazarathpet, Chennai - 123 Chennai TAMIL NADU	9994382839 mayookha.madhu@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional Ethics Commitee	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition:L84\|\|Corns and callosities. Ayurveda Condition: KADARAH,

Intervention / Comparator Agent

Type	Name	Details
Comparator Agent	Shalaka Dahana	Rooksha Dahana(thermal Cautery) will be done on the affected area of the sole, after Chedana Karma, using red hot Panchaloha Shalaka in the Pratisarana manner, until Samyak Dagdha Lakshana is obtained. The procedure will be done once a week, for 4 weeks.
Intervention	Thaila Dahana	Sneha Dahana(thermal Cautery) will be done on the affected area of the sole, after Chedana Karma, using Tila Thailam (2ml) heated upto its smoke point, until Samyak Dagdha Lakshana is obtained. The procedure will be done once a week, for 4 weeks.

Inclusion Criteria

Age From	16.00 Year(s)
Age To	60.00 Year(s)
Gender	Both
Details	Lesions with Features of Kadara Kadara occuring in Paada (soles)

ExclusionCriteria

Details

Those C/I for Agnikarma
Ucontrolled Systemic Conditions like Diabetes mellitus
Participants with any structural Foot Deformity
Participants who are known case of Hepatic. Renal, Neurological, Infective pathologies.
Participants diagnosed with Ca, AIDS, and those with Psycholgical disturbances

Method of Generating Random Sequence

Coin toss, Lottery, toss of dice, shuffling cards etc

Method of Concealment

Not Applicable

Blinding/Masking

Open Label

Primary Outcome

Outcome	TimePoints
Chane in McGill Pain index score Change in Dr. Frank Painter grading of soft tissue tenderness Change in Dischage, consistency, size of the swelling, size of wound after excision, grading of wound healing	4 weeks

Secondary Outcome

Outcome	TimePoints
Nil	Nil

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

N/A

Date of First Enrollment (India)

02/08/2021

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="0"
Months="8"
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

The study is being conducted to compare the effect of Shalakadahana(Rookshadahana) and Thailadahana(Snehadahan) in Kadara , after Chedana Karma in both the groups, each comprising 20 participants. The null hypothesis is that both Shalakadahana and Thailadahana are not effective in the management of Kadara. The two alternate hypothesis are 1) Shalakadaha is effective in the management of Kadara 2)Thailadahana is effective in the management Kadara.