CTRI

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CTRI Number

CTRI/2025/12/098496 [Registered on: 04/12/2025] Trial Registered Prospectively

Last Modified On:

02/12/2025

Post Graduate Thesis

Type of Trial

BA/BE

Type of Study

Study Design

Randomized Factorial Trial

Public Title of Study

Severe painful dry cracks of palms and soles

Scientific Title of Study

Randmoised open labled clinical study of different treatment modalities in vipadika w.s.r to Palmo plantar psoriasis

Trial Acronym

RCTV

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Shradha
Designation	UG BAMS II Professional
Affiliation	BVVS Ayurved Medical College and Hospital ,
Address	UG BAMS 2nd proffessional Department of panchakarma Bagalkot KARNATAKA 587101 India
Phone	9353752845
Fax
Email	shradhahosamath07@gamil.com

Details of Contact Person
Scientific Query

Name	Dr Asha
Designation	Associate Professor
Affiliation	BVVS Ayurved Medical College and Hospital ,
Address	Department of panchakarma BVVS ayurveda medical college and hospital Department of panchakarma BVVS ayurveda medical college and hospital bagalkot Bagalkot KARNATAKA 587101 India
Phone	9164664172
Fax
Email	drashaanandd@gmail.com

Details of Contact Person
Public Query

Name	Dr Asha
Designation	Associate Professor
Affiliation	BVVS Ayurved Medical College and Hospital ,
Address	Department of panchakarma BVVS ayurveda medical college and hospital Bagalkot Department of panchakarma BVVS Ayurved Medical College and hospitalBagalkot Bagalkot KARNATAKA 587101 India
Phone	9164664172
Fax
Email	drashaanandd@gmail.com

Source of Monetary or Material Support

BVVS Ayurved Medical College and Hospital , Bagalkote-587101, KARNATAKA ,India

Primary Sponsor

Name	BVVS Ayurved Medical College and Hospital , Bagalkote-
Address	BVVS Ayurved Medical College and Hospital , Bagalkote-587101, KARNATAKA ,India
Type of Sponsor	Private medical college

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Shradha	BVVS Ayurved Medical College and Hospital	Department of panchakarma Bagalkot KARNATAKA	9353752845 shradhahosamath07@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
IECBVVSAyurvedMedicalCollegeandHospitalBagalkotKarnataka	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition:L989\|\|Disorder of the skin and subcutaneous tissue, unspecified. Ayurveda Condition: VIPADIKA,

Intervention / Comparator Agent

sno	Intervention/Comparator	Type	Drug-Type	Procedure Name	Details
1	Comparator Arm	Procedure	-	siravyadha	(Procedure Reference: vangasena, Procedure details: siravyadha 15 days once lepa Oral medicines) (1) Medicine Name: patolamooladi kashyaya tablet, Reference: charaka samhita, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 4(g), Frequency: bd, Duration: 2 Months

Inclusion Criteria

Age From	18.00 Year(s)
Age To	60.00 Year(s)
Gender	Both
Details	1. Patient willing to participate in research study 2. Diagnosed case of Vipadika patients with age group between 18 to 60 years of either sex.

ExclusionCriteria

Details

1.patient associtated with other type of kusta 2.Systemic disorder like uncontrolled DM ,HTN ,Autoimmune diseases which interfere with couse of treatment 3.Pregnancy and lactation

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

On-site computer system

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
to assess subjective and objective Paramaters Cracks, Bleeding , Pain ,Itching ,Burning sensation	30 days

Secondary Outcome

Outcome	TimePoints
to assess Subjective and objective parameters Cracks ,Bleeding , Pain ,Itching	15th 30th day

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

N/A

Date of First Enrollment (India)

30/12/2025

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="0"
Months="3"
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

healthy skin is a mirroring of general health .Any diseases related to the skin not only effects the patient but collectively effect on social ,psychologically , physical status of the patient .Vipadika is one among the Kshudra kusta features with pani pada sputana(fissures in palm and soles) teevra vedana( painful ) Daha ( burning sensation ) it mainly associated with vata along with pitta or kapha dosha . The symptoms can be corelated with palmo plantar psoriasis . Plamo plantar psoriasis is common chronic immune mediated ,inflammatory ,proliferative ,non-communicable disease of skin influencing people who are genetically predisposed with habitat having a crucial role in pathogenesis The prevelance of psoriasis imprecisely ranges between 2 and 3 % worlwide . there are many treatment manners accessible but since its chronic relapsing nature Palmo plantar psoriasis is a challenging to treat with modern medical science. This Study focuses on evaluation of "Randomised open labelled clinical study of different treatment modalities in vipadika w.s.r to Palmo plantar psoriasis "