| CTRI Number |
CTRI/2025/08/093358 [Registered on: 20/08/2025] Trial Registered Prospectively |
| Last Modified On: |
20/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Randomized Controlled Trial of Tintidikadi Lepa Followed by Til Tail Padabhyanga in maids w.s.r to Padadari |
|
Scientific Title of Study
|
A Randomized Controlled Trial of Tintidikadi Lepa Followed by Til Tail Padabhyanga in Maids w.s.r to Padadari |
| 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 Vishnu Namdev Walwate |
| Designation |
BAMS PG Scholar |
| Affiliation |
GAC Nagpur |
| Address |
Government Ayurved
college and Hospital Sakkardhara Chowk Raje Raghuji Nagar
Nagpur 440024 Maharashtra India
Nagpur
MAHARASHTRA
440024
India |
| Phone |
9657526630 |
| Fax |
- |
| Email |
vishnuwalwate9977@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manjiri Vaibhav Bhende |
| Designation |
Associate Professor |
| Affiliation |
GAC Nagpur |
| Address |
Government Ayurved
college and Hospital Sakkardhara Chowk Raje Raghuji Nagar
Nagpur440024 Maharashtra India
Nagpur
MAHARASHTRA
440024
India |
| Phone |
9657526630 |
| Fax |
|
| Email |
manjiri.palnitkar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr.Vishnu Namdev Walwate |
| Designation |
BAMS PG Scholar |
| Affiliation |
GAC Nagpur |
| Address |
Government Ayurved
college and Hospital Sakkardhara Chowk Raje Raghuji Nagar
Nagpur440024 Maharashtra India
Nagpur
MAHARASHTRA
440024
India |
| Phone |
9657526630 |
| Fax |
- |
| Email |
vishnuwalwate9977@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD patients of Government Ayurved College and Hospital, Nagpur. |
|
|
Primary Sponsor
|
| Name |
Dr Vishnu Namdev walwate |
| Address |
Government Ayurved College and Hospital Sakkardhara Square
Raje Raghuji Nagar Nagpur Maharashtra 440024 India
|
| Type of Sponsor |
Other [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 VishnuNamdev walwate |
Government Ayurved college and Hospital, Nagpur and its periphery |
OPD 6,
Swastharakshan
Department,
Government Ayurved
College and Hospital,
sakkardhara chowk,
raje Raghuji Nagar,
Nagpur, Maharashtra.
Nagpur
MAHARASHTRA
Nagpur
MAHARASHTRA |
9657526630
vishnuwalwate9977@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L749||Eccrine sweat disorder, unspecified. Ayurveda Condition: PADADARI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | lepa, | (Procedure Reference: Bhaishajya ratnawali, Procedure details: a. Gud 1part
b. Lavan 1part
c. Ghrita 1 part
d. Tintidika root peel 1 part are grounded together & are mixed with 8 part Goomutra (cow urine) & then apply to cracked heel.)
| | 2 | Comparator Arm | Procedure | - | lepa, लेप | (Procedure Reference: Bhaishjya Ratnavali, Procedure details: Application of haritaki lepa once a day for 30 days)
|
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
1.Individuals having Age Group 25-50 years
2.Individuals having any 2 or more samanya Lakshanas of padadari out of following
Padasfutan Vedana Rukshata Daha kandu
3.Irrespective of education religion and socio economic status
4.Individuals willing for regular follow up.
|
|
| ExclusionCriteria |
| Details |
1.Individuals having Diabetes, Psoriasis, Athletes foot.
2.Individuals Suffering from Skin disorder like Hyperkeratotic eczema.
3.Individuals having history of burn.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To the effect of Tintidikadi Lepa with til tail padabhyanga on Evaluation of heel skin by specially grading scale.
2.To the effect of Haritaki Lepa on Evaluation of heel skin by specially grading scale.
3.To compare effect of Tintidikadi Lepa on Evaluation of heel skin by specially grading scale.
|
7 15 30 days
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To study the literature about Padadari according to Ayurved and Modern science.
2.To study the literature of Tintidika,Guda ,Lavan ,Goomutra, Ghrita ,Til tail in Ayurveda and Modern science.
|
1 year |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
01/09/2025 |
| 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="5" |
|
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
|
Title: “A Randomized Controlled Trial of Tintidikadi Lepa Followed by Til Tail Padabhyanga in Maids w.s.r to Padadari.’’ Aim :To the effect of Tintidikadi Lepa Followed by Til Tail Padabhyanga in Padadari in maids. Objectives :
ØPrimary Objective: 1.To the effect of Tintidikadi Lepa with til tail padabhyanga on Evaluation of heel skin by specially grading scale. 2.To the effect of Haritaki Lepa on Evaluation of heel skin by specially grading scale. 3.To compare effect of Tintidikadi Lepa on Evaluation of heel skin by specially grading scale. ØSecondary Objective: 1.To study the literature about Padadari according to Ayurved and Modern science. 2.To study the literature of Tintidika,Guda ,Lavan ,Goomutra, Ghrita ,Til tail in Ayurveda and Modern science Methodology - study design Screening of the subjects from population will be done on the basis of Inclusive criteria and exclusive criteria. They will be divided into two groups by computerised random sampling method after taking consent. GroupA - 40 individuals will be given with application of Tintidikadi lepa at sleeping hours Padabhyanga next morning daily for 30 days. Group B- 40 individuals will be given with application of Haritaki lepa at sleeping hours daily for 30 days. Then Assessment will be done by Objective and Subjective Parameters before and after study and subjective parameters On D-0, D-30, and D- 60. Statistical analysis with appropriate test and interpretation will be done. Study population: On the basis of clinical examination and history, Total individuals will be selected according to their eligibility criteria. GroupA - 40 individuals will be given with application of Tintidikadi lepa at sleeping hours Padabhyanga next morning daily for 30 days. Group B- 40 individuals will be given with application of Haritaki lepa at sleeping hours daily for 30 days. Inclusion Criteria- 1)Individuals having Age Group 25-50 years. 2)Individuals having any 2 or more samanya Lakshanas of padadari out of following - a) Padasfutan b)Vedana c)Rukshata d)Daha e) kandu 3)Irrespective of education, religion and socio economic status. 4)Individuals willing for regular follow up. Exclusion Criteria: 1)Individuals having Diabetes, Psoriasis, Athletes foot. 2)Individuals Suffering from Skin disorder like Hyperkeratotic eczema. 3)Individuals having history of burn. ØWithdrawal criteria:
1)Subject who develop any unwanted symptoms during the study. 2)Subject who unable to give follow up.
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