| CTRI Number |
CTRI/2025/03/082429 [Registered on: 17/03/2025] Trial Registered Prospectively |
| Last Modified On: |
16/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Ayurvedic Medicine in Kadar (Corn) |
|
Scientific Title of Study
|
RANDOMIZED CONTROLLED CLINICAL STUDY TO EVALUATE THE EFFICACY OF KADALI PRATISARNIYA KHAR IN THE MANAGEMENT OF KADAR 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 |
Dr Hrushikesh Suresh Bhakare |
| Designation |
MS Shalyatantra Scholar (Ayurved) |
| Affiliation |
Dr VJD Gramin Ayurved Mahavidyalaya Near Renuka mata mandir patur |
| Address |
Dr VJD Gramin Ayurved Mahavidyalaya Near Renuka mata mandir patur tal Patur Dist Akola pin 444501 Maharashtra India
Akola
MAHARASHTRA
444501
India |
| Phone |
9730273047 |
| Fax |
|
| Email |
hrushibhakare24@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jagruti V Rode |
| Designation |
Reader MS Shalyatantra |
| Affiliation |
Dr VJD Gramin Ayurved Mahavidyalaya Near Renuka mata mandir patur |
| Address |
OPD no Department of Shalyatantra Dr VJD Gramin Ayurved Mahavidyalaya Near Renuka mata mandir patur tal Patur Dist Akola
Akola
MAHARASHTRA
444501
India |
| Phone |
9604607077 |
| Fax |
|
| Email |
drjagrutiambekar50@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jagruti V Rode |
| Designation |
Reader MS Shalyatantra |
| Affiliation |
Dr VJD Gramin Ayurved Mahavidyalaya Near Renuka mata mandir patur |
| Address |
OPD no Department of Shalyatantra Dr VJD Gramin Ayurved Mahavidyalaya Near Renuka mata mandir patur tal Patur Dist Akola
Akola
MAHARASHTRA
444501
India |
| Phone |
9604607077 |
| Fax |
|
| Email |
drjagrutiambekar50@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Shalyatantra Dr VJD Gramin Ayurved Mahavidyalaya Near Renuka mata mandir patur tal patur dist Akola PIN code 444501 |
|
|
Primary Sponsor
|
| Name |
Dr VJD Gramin Ayurved Mahavidyalaya |
| Address |
Dr VJD Gramin Ayurved Mahavidyalaya Near Renuka mata mandir patur tal patur Dist Akola Maharashtra India Pin 444501 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Hrushikesh Suresh Bhakare |
Dr.VJD Gramin Ayurved Mahavidyalaya |
OPD no.18 , Department of Shalyatantra,Dr.VJD Gramin Ayurved Mahavidyalaya,near Renuka mata mandir,P atur,Tal-Patur,Dist-Akol a
Akola MAHARASHTRA
Akola
MAHARASHTRA |
9730273047
hrushibhakare24@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Dr. VJD Gramin Ayurved Mahavidyalaya Patur |
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 | Drug | Classical | | (1) Medicine Name: Kadali pratisarniya kshar , Reference: Sushruta Sutrasthan 11/12, Route: Topical, Dosage Form: Kshara , Dose: 2(mg), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: | | 2 | Comparator Arm (Non Ayurveda) | | - | Salicyclic acid 12% ointment | Salicylic acid, when applied to the skin surface, works by causing the cells of
the epidermis to slough off more readily, preventing pores from clogging up, and allowing room for new cell growth. |
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
.1
Patients with signs and symptoms ofKadar (Corn) will be selected.
2.
Age: between 25 - 50 years irrespective of sex
3.
Patients will be selected who are willing to give informed consent and
ready to comply with the protocol |
|
| ExclusionCriteria |
| Details |
1.Patient with Pittaj prakruti
2.Patients with Uncontrolled Systemic disorders like Diabetes, Hypertension.
3.Patients with infective conditions like HIV and Hbs Ag were excluded.
4.Pregnant women.
5.Patient on anti-platelet drug |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)Pain
2)Tenderness
3)Consistency
Will be decreased of kadar with reference to corn |
Follow up
0,3rd,5th,7th,9th,11th,13th,15th days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Decrease in symptoms of Kadar |
18 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
27/03/2025 |
| 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 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
|
Placing the feet on hard/ rough stone/surface or wound caused by thorns etc. or by doshas getting aggravated together along with Meda and Rakta dhatu, gives rise to a tumour-like hard induration deep seated in the middle and elevated at the periphery, having the size of a Kola and presenting the symptoms of pain and exudation, sometimes discharge is known as Kadara. Kadara has been described in the classical literature, like Sushruta Samhita under the heading Kshudra Roga. It is a condition formed by vitiation of Vata and Kapha Dosha which in turn vitiates Rakta and Meda dhatus. Sushruta has mentioned four types of treatments, i.e., bheshaja (medicines), ksharakarma (Application of alkali preparation), agnikarma (Cauterization) and Shastrakarma (Surgery) as chikitsopakarma for Asha (piles) in Sushruta samhitha sutra sthana and he has given more emphasis on ksharakarma which also holds good for treatment o fCharmakeela and Kadara. Kadara is referred to be effectively treated with Kshara Karma as Teekshna Ksharalepa performs actions like Chedana, Bedhana, Lekhana. Teekshna Kshara pacifies the Vata and Kapha Doshas and dissolves Meda Dhatu which is needed for the Samprapti Vighatana ofKadara. Corn can be correlated with kadara described in Ayurveda Samhitas. A corn is known as hyperkeratosis ofskin. It usually occurs at the pressure sites 1.e. sole and toes. It presents as a whitish, circular area that can be extremely painful when palpated. Corns can also appear on the sides or the tips of the paw pad (these being not much common). It can sometimes appear between the toes is softer in consistency and less painful.The reason for the pain is that corns contain a cone-shaped core/root whose point can press on a nerve, causing severe pain and lameness as fi one is walking with a sharp pebble in the shoe. The management of corn consists of destruction of abnormal tissue by application of salicylic acid, invasive procedures like cryotherapy, laser, electric and chemical cauterization and complete excision by surgery. These procedures are relatively expensive and have bothersome post wound care. Corn is a horny induration of the cuticle with a hard cent |