CTRI Number |
CTRI/2025/04/083802 [Registered on: 01/04/2025] Trial Registered Prospectively |
Last Modified On: |
28/03/2025 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug Ayurveda |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
To study the effect of Agnikarma by Tapta Tilataila and Ksharakarma by Apamarga Pratisarneeya Kshara in the management of Corn |
Scientific Title of Study
|
A Randomized Comparative Clinical Study to evaluate the efficacy of Agnikarma by Tapta Tilataila and Ksharakarma by Apamarga Pratisarneeya Kshara in the management of Kadara with special reference 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 |
Dr Summayyaanjuma Muchale |
Designation |
PG Scholar shalyatantra |
Affiliation |
BVVS Ayurveda Medical College and Hospital Bagalkot |
Address |
Department of Shalyatantra BVVS Ayurveda Medical College and Hospital Bagalkot BVVS Ayurveda Medical College and Hospital Bagalkot Bagalkot KARNATAKA 587101 India |
Phone |
7760561943 |
Fax |
|
Email |
sumaiyyamuc@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Pallavi A Hegde |
Designation |
Professor |
Affiliation |
BVVS Ayurveda Medical College and Hospital Bagalkot |
Address |
Department of Shalyatantra BVVS Ayurveda Medical College and Hospital Bagalkot BVVS Ayurveda Medical College and Hospital Bagalkot Bagalkot KARNATAKA 587101 India |
Phone |
9448636321 |
Fax |
|
Email |
drpallaviah@rediffmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Mallikarjun S Hiremath |
Designation |
Incharge Principal and Professor |
Affiliation |
BVVS Ayurveda Medical College and Hospital Bagalkot |
Address |
Department of Rachana Sharir BVVS Ayurveda Medical College and Hospital Bagalkot 587101
Bagalkot KARNATAKA 587101 India |
Phone |
9482631399 |
Fax |
|
Email |
malikdost4u@gmail.com |
|
Source of Monetary or Material Support
|
BVVS Ayurved Medical College And Hosital Bagalkot Karnataka India 587101 |
|
Primary Sponsor
|
Name |
BVVS Ayurveda Medical College And Hospital |
Address |
Department of shalyatantra BVVS Ayurveda Medical College and Hospital Bagalkot Karnataka India 587101 |
Type of Sponsor |
Private medical college |
|
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 Summayyaanjuma Muchale |
BVVS Ayurveda Medical College and Hospital |
Department of shalyatantra BVVS Ayurveda Medical College and Hospital BVVS Campus
Bagalkot Karnataka India 587101 Bagalkot KARNATAKA |
7760561943
sumaiyyamuc@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
IEC BVVS Ayurveda Medical College and Hospital Bagalkot |
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: Sushruta samhita sutrasthana 12th chapter, Procedure details: Lekhana will be carried daily before Agnikarma .The taila is heated to the temperature of toleration capacity of the patient & will be dribbeled over the site of Kadara with the dropper per sitting. Taila will be kept in situ with the Pali constructed around Kadara till it gets cooled. ) (1) Medicine Name: Tapta tila taila, Reference: sushruta samhita sutrasthana 12th chapter, Route: Topical, Dosage Form: Taila, Dose: 50(ml), Frequency: od, Duration: 7 Days | 2 | Comparator Arm | Procedure | - | kShArakarma, क्षारकर्म | (Procedure Reference: sushruta samhita sutrasthana chapter 11, Procedure details: Lekhana karma will be carried before application of ksharakarma.Pratisarana of Apamarga Kshara will be done on Kadara with the help of Shalaka Yantra left in situ for Shata Matra Kala.) (1) Medicine Name: apamarga pratisaraniya kshara, Reference: sushruta samhita sutrastana chapter 11, Route: Topical, Dosage Form: Kshara, Dose: 2(g), Frequency: od, Duration: 7 Days |
|
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
Inclusion Criteria
Diagnosed Patients of Kadara (Corn) of either gender.
Patients of Kadara with age group between 18 to 60 years.
Patients with single or multiple corn.
Patients of Kadara with controlled hypertension and diabetes mellitus |
|
ExclusionCriteria |
Details |
Patients with infected corn.
Patients of Kadara with retroviral disease or HBsAg.
Pregnant and Lactating women. |
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
On-site computer system |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
To know the efficacy of Agnikarma by Tapta Tilataila and Ksharakarma by Apamarga Pratisarneeya Kshara in the management of Kadara with special reference to Corn |
7 days |
|
Secondary Outcome
|
Outcome |
TimePoints |
AIM:
1.To compare the efficacy of Agnikarma with Tapta Tilataila and Ksharakarma with Apamarga Pratisaraneeya Kshara in the management of Kadara with special reference to Corn.
OBJECTIVES:
2.To evaluate the efficacy of Agnikarma with Tapta Tilataila in the management of Kadara with special reference to Corn .
3.To evaluate the efficacy of Ksharakarma with Apamarga Pratisaraneeya Kshara in the management of Kadara with special reference to Corn . |
7 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)
|
10/04/2025 |
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="6" Days="0" |
Recruitment Status of Trial (Global)
|
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
|
India is an agriculture based country, where 20% of total population lives in urban areas where as rest 80% living in rural. As it is developing country, where most of the population rely on manual labor either for agriculture or construction and such other means of livelihood. Due to poor protective measures, ignorance, negligence and poor economic status, chances of developing foot and palm lesions are quite high, most common lesion which is seen in feet is corn .The incidence of corns on the feet has been reported to be ranging anywhere from 14% to 48%. They have been reported to affect older age groups with a slight female predominance due to wearing narrow shoes. The elderly are also subject to loss of the protective fat pad cushioning, called fat pad atrophy, which can increase the incidence of painful corn. Corn is localized hyperkeratosis of the skin, it usually occurs at the sites of pressure e.g. on sole and toes. There is usually a horny induration of the cuticle with a hard centre. Corn may be painful particularly when it is rubbed. A corn has deep central core which reaches the deeper layers of dermis. Acharya Sushruta has explained 44 types of Kshudra Rogas in Nidana Sthana, in which Kadara is one, that is caused due to injury by Sharkaraadi (soil, pebble, stone) or Kanthaka (thorn prick) while walking. This leads to aggravation of Dosha, and these Doshas flow through Meda and Rakta, giving rise to Granthi (tubercle), which is Sakeela Kathina (hard like a bolt) , Nimna Madhya Unnata (depressed at the edges and elevated in middle) of feet ,of the size of Kola (jujuba fruit) having pain and exudation. Acharya Sushruta in Chikitsasthana explained about Kadara Chikitsa in Kshudra Roga Chikitsa Adhaya where he mentioned Utkartna followed by Sneha Dahana. Acharya Sushruta in Kshara Pakavidhi Adhyaya explained its benefits on various Twak Vikara including Kshudra Rogas. Kshara is mentioned as Pradhana as compared to Shastra and Anushastra by its properties of Chedana, Bhedana, Lekhana Karma. Further Pratisarneeya Kshara is indicated in Twakagata Vikara.While in the context of Agnikarmavidhi Adhyaya, Acharya Sushruta explained that Agni Karma is more effective than Kshara Karma because of its Apunarbhava quality, and the Rogas which cannot be managed by Aushadhi, Shastra and Kshara Karma can be managed by Agnikarma. Various Dahanopakarana are mentioned as per the Dhatu involvement, where Sneha can be used for Sira Snayugata Roga’s. Acharya Charaka in Grahani Chikitsa Adhyaya explained about Dhatu and Upadhatu where he mentions Sira, Khandara as Upadhatu of Rakta and Snayu as Upadhatu of Meda. As in Kadara, Meda and Rakta are vitiated Snehadahana can be considered. In allied science conservative measures for management of corn are salicylic acid in collodion on successive nights may be applied or central local applications have been effective such as carnation cap. Corn has tendency to recur. Preventive measures such as using soft shoes or soft pads at pressure point of the sole. If preventive measures fail and corn is painful, it should be excised with particular care to take off the deep root of the central core. This often prevents reccurence. Acharya Sushruta explains the management of Kadara by Utkartana followed by Sneha Dahana. Acharya Sushruta explained Tilataila qualities as Ushna, Vyavayi, Sukshma, Vishada, Vikasi, Twakprasadana .Hence Tilataila is taken as Sneha Dravya for the Dahanakarma at Kadara site. Acharya Bhavaprakasha explained the Rasa of Apamarga as Katu, Tikta; Tikshna Gunatmaka; Ushna Virya; Katu Vipaka; Kapha Vatahara, Shoolahara, Medohara, Vranhita and Twachya in action.By the previous research works Apamarga Pratisarneeya Kshara is taken as standard for the study. The procedure can be carried on OPD basis. There is no creation of wound, hence needs no anaesthesia, antibiotics and analgesics. The procedure will not hamper individuals routine activities and the time taken by Agnikarma or Ksharakarma in corn management is minimal when compared to the wound healing rate which ranges from few weeks to month after excision. Hence the present study is undertaken to compare the efficacy of Agnikarma with Tilataila and Ksharakarma with Apamarga Pratisarneeya Kshara in the management of Kadara with special reference to Corn .” |