| CTRI Number |
CTRI/2025/12/099282 [Registered on: 17/12/2025] Trial Registered Prospectively |
| Last Modified On: |
16/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A clinical study to evaluate the effect of aloe vera in the management of Cracked Heels |
|
Scientific Title of Study
|
A pharmacoclinical evaluation of Kumari Aloe barbadensis mill wsr to Padadari Cracked Heel |
| 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 Kavana B S |
| Designation |
2nd year PG scholar Dravyaguna vignana |
| Affiliation |
KVG Ayurveda Medical College and Hospital Sullia |
| Address |
Dept of Dravyaguna Vignana 2nd floor KVG Ayurveda Medical College and Hospital Ambate adka Sullia D K Karnataka 574327
Dakshina Kannada
KARNATAKA
574327
India |
| Phone |
8971573525 |
| Fax |
|
| Email |
kavanabarekare@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajashekhara N |
| Designation |
Professor and HOD Dravyaguna vignana |
| Affiliation |
KVG Ayurveda Medical College and Hospital Sullia |
| Address |
Dept of Dravyaguna Vignana 2nd floor KVG Ayurveda Medical College and Hospital Ambate adka Sullia D K Karnataka 574327
Dakshina Kannada
KARNATAKA
574327
India |
| Phone |
7619124223 |
| Fax |
|
| Email |
20drnraj20@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kavana B S |
| Designation |
2nd year PG scholar Dravyaguna vignana |
| Affiliation |
KVG Ayurveda Medical College and Hospital Sullia |
| Address |
Dept of Dravyaguna Vignana 2nd floor KVG Ayurveda Medical College and Hospital Ambate adka Sullia D K Karnataka 574327
Dakshina Kannada
KARNATAKA
574327
India |
| Phone |
8971573525 |
| Fax |
|
| Email |
kavanabarekare@gmail.com |
|
|
Source of Monetary or Material Support
|
| KVG ayurveda medical college and hospital |
|
|
Primary Sponsor
|
| Name |
KVG ayurveda medical college and hospital Sullia |
| Address |
KVG Medical College and Hospital Ambate Adka Kurunjibag Sullia 574327 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Kavana B S |
KVG ayurveda medical college and hospital |
Department of dravyaguna vignana 2nd floor KVG Medical College and Hospital Ambate Adka Kurunjibag Sullia 574327
Dakshina Kannada
KARNATAKA |
8971573525
kavanabarekare@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KVG Ayurveda Medical College Ethical Committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L988||Other specified disorders of the skin and subcutaneous tissue. Ayurveda Condition: PADADARI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Fresh aloe vera, Reference: NA, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 1(NA), Frequency: od, Bhaishajya Kal: Pragbhakta, Duration: 14 Days, anupAna/sahapAna: No, Additional Information: -applied at night daily(2) Medicine Name: Aloe vera processed in tila taila, Reference: NA, Route: Topical, Dosage Form: Taila, Dose: 1(NA), Frequency: od, Bhaishajya Kal: Pragbhakta, Duration: 14 Days, anupAna/sahapAna: No, Additional Information: -applied at night daily(3) Medicine Name: Aloe vera processed in eranda taila, Reference: NA, Route: Topical, Dosage Form: Taila, Dose: 1(NA), Frequency: od, Bhaishajya Kal: Pragbhakta, Duration: 14 Days, anupAna/sahapAna: No, Additional Information: -applied at night daily quantity sufficient |
|
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients who have cracks on the foot
2 Patients of the age group between 15 to 60
3 Patients of both sex |
|
| ExclusionCriteria |
| Details |
1 Patients suffering from any dreadful diseases
2 Patients suffering from diabetes mellitus psoriasis athletes foot
3 Patients with infection and oozing |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in fissure depth,number and severity score |
Day 0 to day 15 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To asses improvement in associated symptoms such as dryness, pain, cracks along with monitoring the safety and tolerability of aloe vera in subjects with Padadari |
Day 8 |
|
|
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 1 |
|
Date of First Enrollment (India)
|
28/12/2025 |
| 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="0"
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 aims to evaluate the pharmacoclinical effectiveness of Kumari (Aloe vera )in the management of Padadari (heel fissures). A total of 30 participants suffering from cracked heels will be randomly divided into three groups of ten each. Group A will receive topical application of fresh Aloe vera, Group B will be treated with Aloe vera processed in Tila Taila (sesame oil), and Group C will receive Aloe vera processed in Eranda Taila (castor oil). The intervention will be applied regularly for 7 days, and the therapeutic response will be assessed through changes in fissure depth, skin hydration, dryness, pain, and overall skin integrity. The study intends to compare the clinical outcomes among the three formulations to determine which preparation of Aloe vera provides the most effective healing of cracked heels, while also evaluating patient comfort, acceptability, and safety. |