| CTRI Number |
CTRI/2025/05/087706 [Registered on: 27/05/2025] Trial Registered Prospectively |
| Last Modified On: |
24/04/2025 |
| 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 Haritaki Churna with Goghruta local application in Padadari that is Cracked Heels in age group of 30 to 80 years |
|
Scientific Title of Study
|
Randomised Open Controlled clinical trial to evaluate the efficacy of Haritaki Churna with Goghruta local application in Padadari w s r to Cracked Heels |
| 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 Shivani Raju Mohod |
| Designation |
PG Scholar |
| Affiliation |
Yashwant Ayurvedic College Post Graduate Training and Research Centre Kodoli |
| Address |
OPD No 17 kayachikitsa Department Second Floor
Yashwant Ayurvedic College Post Graduate Training and Research Centre Kodoli Tal Panhala Dist Kolhapur Kolhapur MAHARASHTRA
416114 India
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9423628781 |
| Fax |
|
| Email |
shivanimohod93@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vasundhara Borakhade |
| Designation |
MD Phd |
| Affiliation |
Yashwant Ayurvedic College Post Graduate Training and Research Centre Kodoli |
| Address |
OPD No 17 kayachikitsa Department Second Floor
Yashwant Ayurvedic College Post Graduate Training and Research
Centre Kodoli Tal Panhala Dist Kolhapur Kolhapur MAHARASHTRA
416114 India
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9822885710 |
| Fax |
|
| Email |
vasudha.borakhade@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shivani Mohod |
| Designation |
PG scholar |
| Affiliation |
Yashwant Ayurvedic College Post Graduate Training and Research Centre Kodoli |
| Address |
OPD No 17 kayachikitsa Department Second Floor
Yashwant Ayurvedic College Post Graduate Training and Research
Centre Kodoli Tal Panhala Dist Kolhapur Kolhapur MAHARASHTRA
416114 India
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9423628781 |
| Fax |
|
| Email |
shivanimohod93@gmail.com |
|
|
Source of Monetary or Material Support
|
| Yashwant Ayurvedic College Post Graduate Training and Research
Centre Kodoli ,Tal Panhala, Dist Kolhapur MAHARASHTRA
Pin code 416114 |
|
|
Primary Sponsor
|
| Name |
Dr Shivani Mohod |
| Address |
OPD No 17 kayachikitsa Department Second Floor
Yashwant Ayurvedic College Post Graduate Training and Research
Centre Kodoli Tal Panhala Dist Kolhapur Kolhapur MAHARASHTRA
416114 India |
| Type of Sponsor |
Other [Self] |
|
|
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 Shivani Raju Mohod |
Yashwant Dharmartha Rugnalaya |
OPD No 17 kayachikitsa Department Second Floor
Yashwant Ayurvedic College Post Graduate Training and Research
Centre Kodoli Tal Panhala Dist Kolhapur Kolhapur MAHARASHTRA
416114 India
Kolhapur
MAHARASHTRA |
9423628781
shivanimohod93@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Yashwant Ayurvedic College PGT and RC Kodoli Tal Panhala Dist Kolhapur Maharashtra India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L99||Other disorders of skin and subcutaneous tissue in diseases classified elsewhere. Ayurveda Condition: PADADARI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Haritaki churna with goghrit, Reference: Rasaratnasamuchay adhyay25 shlok40, Route: Topical, Dosage Form: Lepa Churna, Dose: 10(g), Frequency: hs, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Gandhak malhar, Reference: Rasatarangini adhyay8 schlok63 to 65, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 10(g), Frequency: hs, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients irrespective of gender caste religion
30 to 80 yrs age group
Patient having sign and symptoms of padadari
padayo kurute dari ruksh twak saruja tal
Patients ready to trial and give written consent |
|
| ExclusionCriteria |
| Details |
Known case of Gangrenous foot
Vascular skin disease pyogenic granuloma port wine stains keratosis pilaris |
|
|
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 |
| To study the efficacy of local application of haritaki churna with goghrut in padadari disease w s r to cracked heels by assessing rukshata kandu ruja number of fissures in feet length of cracks |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study padadari in details from various ayurvedic text and samhita
To asses various causes responsible for padadari
To study the efficacy of local application of haritaki churna with goghrut in saruja,padayok kurute dari rukshta
To compare the effect of trial drug with Gandhak malhar
To study modern aspect of cracked heels |
30 days |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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 3 |
|
Date of First Enrollment (India)
|
30/05/2025 |
| 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
|
To study Padadari in detail from various ayurvedic texts To study efficacy of Haritaki Churna with Goghruta local application in signs of number of dari in feet ruja kandu length of cracks and rukshata To study the modern view of cracked heels in detail To achieve the outcome of study in 30 days |