CTRI

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CTRI Number

CTRI/2025/02/080891 [Registered on: 19/02/2025] Trial Registered Prospectively

Last Modified On:

03/09/2025

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Ayurveda

Study Design

Single Arm Study

Public Title of Study

Ayurvedic treatment for Skin diseases:A clinical study to evaluate efficacy of dashanga lepa ghritha on dadru kushta

Scientific Title of Study

Evaluation of Upashayatmaka effect of Dashanga Lepa Ghritha In Dadru kushta(Dermatophytosis)-AN -IN VITRO-IN -VIVO-STUDY

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 Amith Kumar M
Designation	BAMS
Affiliation	Alvas Ayurveda Medical College And Hospital,Moodubidre,Dakshina Kannada,Karnataka
Address	Alvas Ayurveda Medical college Amd Hospital,Moodubidre,Dakshina Kannada,Karnataka Alvas Ayurveda Medical college Amd Hospital,Moodubidre,Dakshina Kannada,Karnataka Dakshina Kannada KARNATAKA 574227 India
Phone	9148956559
Fax
Email	amithkumarm99@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Geetha B Markande
Designation	Professor
Affiliation	Alvas Ayurveda Medical College And Hospital
Address	Alvas Ayurveda Medical College And Hospital,Moodubidre,Dakshina Kannada,Karnataka Alvas Ayurveda Medical College And Hospital,Moodubidre,Dakshina Kannada,Karnataka Dakshina Kannada KARNATAKA 574227 India
Phone	9901859343
Fax
Email	drgeetamk@gmail.com

Details of Contact Person
Public Query

Name	Dr Amith Kumar M
Designation	BAMS
Affiliation	Alvas Ayurveda Medical College And Hospital
Address	Alvas Ayurveda Medical College And Hospital,Moodubidre,Dakshina Kannada,Karnataka Alvas Ayurveda Medical College And Hospital,Moodubidre,Dakshina Kannada,Karnataka Dakshina Kannada KARNATAKA 574227 India
Phone	9148956559
Fax
Email	amithkumarm99@gmail.com

Source of Monetary or Material Support

Alvas Ayurveda Medical College And Hospital,Vidyagiri,Moodubidre,Dakshina Kannada, Karnataka,India Pincode:574227 ALVAS AYURVEDA MEDICAL COLLEGE AND HOSPITAL,MOODUBIDRE,D.K,KARNATAKA

Primary Sponsor

Name	Dr Amith Kumar M
Address	Department Of P.G Studies Roga Nidana Evam Vikriti Vigyana Alvas Ayurveda Medical College And Hospital,Vidyagiri,Moodubidre,Dakshina Kannada ,Karnataka,India Pincode:574227
Type of Sponsor	Other [SELF]

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
Dr Amith Kumar M	Alvas Ayurveda Medical College And Hospital,Moodbidre,Dakshina kannada,karnataka	Opd and Ipd of Alvas Ayurveda Medical College and Hospital,Moodbidre ,Dakshina kannada, Karnataka,pin code ;574227 Dakshina Kannada KARNATAKA	9148956559 amithkumarm99@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
INSTITUTIONAL ETHICAL COMMITTEE ALVAS AYURVEDA MEDICAL COLLEGE	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition:L988\|\|Other specified disorders of the skin and subcutaneous tissue. Ayurveda Condition: DADRU-KUSHTHAH,

Intervention / Comparator Agent

sno	Intervention/Comparator	Type	Drug-Type	Procedure Name	Details
1	Intervention Arm	Drug	Classical		(1) Medicine Name: DASHANGA LEPA GHRITHA, Reference: BHARATBHAISHJYA RATNAKARA, AYURVEDIYA GRANTHI, Route: Topical, Dosage Form: Ghrita, Dose: 1(NA), Frequency: bd, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (2) Medicine Name: 2 Weeks, Reference: No, Route: -, Dosage Form: Ghrita, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information:
2	Intervention Arm	Drug	Classical		(1) Medicine Name: DASHANGA LEPA GHRITHA, Reference: BHARATA BHAISHAJYA RATNAKARA,AYURVEDIYA GRANTHI,TRITIYA , SANGRAHITHA;SHRI NAGINDAS CHAGANLAL SHAHA RASAVAIDYENA,VOLUME 3, PAGE 92, SHLOKA NO 3141, Route: Topical, Dosage Form: Ghrita, Dose: 1(ml), Frequency: bd, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (2) Medicine Name: 2 Weeks, Reference: , Route: , Dosage Form: Ghrita, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (3) Medicine Name: 2 Weeks, Reference: , Route: , Dosage Form: Ghrita, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information:

Inclusion Criteria

Age From	16.00 Year(s)
Age To	60.00 Year(s)
Gender	Both
Details	1.Patients who gave written consent for clinical trial 2. Patients who are fulfilling the diagnostic criteria 3.Patients irrespective of sex and having age group between 16 to 60 years will be included for the study. 4.Patients having history of less than one year of origin.

ExclusionCriteria

Details

1. Patients associated with other types of kushta.
2.Onchomycosis,Tinia capitis,Tinia pedis,Tinea Barberis.
3.patient taking immune suppresive medications.
4.Patients presenting systemic disorders which may interfere in the course of study.
5.Lesions with secondary infection.
6. Pregnant and lactating women.

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
TO DETERMINE THE ANTIFUNGAL ACTIVITY OF DASHANGA LEPA GHRITHA THROUGH IN VITRO -STUDY.	2 -3 DAYS

Secondary Outcome

Outcome	TimePoints
TO DETERMINE THE UPASHAYATMAKA EFFECT OF DASHANGA LEPA GHRITHA IN DADRU KUSHTA.	14 DAYS

Target Sample Size

Total Sample Size="40"
Sample Size from India="40"
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/ Phase 3

Date of First Enrollment (India)

01/03/2025

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="0"
Days="0"

Recruitment Status of Trial (Global)

Not Applicable

Recruitment Status of Trial (India)

Open to Recruitment

Publication Details
Modification(s)

N/A

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Response - NO

Brief Summary
Modification(s)

The 2013 Global Burden of Disease (GBD) Morbidity and Mortality report identified skin diseases as the fourth leading cause of global disability. In 2016, fungal skin diseases were ranked fourth highest in the incidence of disease (2.1 billion cases) when compared to 328 different diseases.

Dermatophytes are fungi that infect skin ,hair and nails and include member of the genera Trichophyton,microsporum and epidermophyton.

Fungal species that are confined to superficial layers of the Human skin are known as Dermatophytes. These infections are commonly referred by the term tinea followed by the area of the body affected .

Dermatophytosis is characterized by annular lesions with the intense itching, erythema, edema and scaling.

Prevalence rate of Tinea Infections has been found to be of 27.5% in Dakshina Kannada, and 36-78% in India and 27% in World-wide.

Increased urbanization, occlusive footwear, and tight clothing also predispose to higher prevalence .

Dadru Kushta is a type of Kshudra Kushta which is Kapha Pittaja in nature characterized by Mandala, Raaga, Kandu, pidaka,parisushka,unnathagra ,Visarpa which simulates the symptoms of dermatophytosis like round, erythematous patches with itching,papules,scaling,elevated border,spreading.

Various treatments modalities like Shodhana, Bahirparimarjana have been mentioned for dadru kushta.Lepana is a type of Bahirparimarjana Chikitsa explained in all the treatises for skin disease .

Dashanga lepa is an external application mentioned in classics for dadru kushta with ingriedients like Shirisha, Yastimadhu,tagara, Rakthachandana, Ela, Jatamamsi, Haridra, Daru Haridra, Kushta,hrivera.

Dashanga lepa is in choorna form and it has to be applied with the ghritha .By considering the Duration of contact with the skin and convinency towards usage , to the patients, form is converted to ghritha .

The word upashaya says a relief which may not be of longer duration .The concept of vyadhi viparitha oushada says,usage of medicines which can give relief .

Even though various studies have been conducted on Dadru Kushta considering the reoccurrence of the illness, present work is intended to study the Upashayatmaka effect of Dashanga lepa Ghritha in patients of Dadru kushta with changes observed in lakshana,along with its antifungal activity.

HYPOTHESIS

H₀:There is no Statistical significant effect of Dashanga Lepa Ghritha in the management of Dadru Kushta.(Dermatopytosis).

H₁:There is a Statistical significant effect of Dashanga lepa Ghritha in the management of Dadru kushta(Dermatopytosis).

Sample Size

Total 40 Patient will be taken for the study.

Grouping

Single arm

Study Design

Clinical Study

For the present study patients irrespective of sex will be selected at random without bias of social, economic, or religion status from the O.P.D and I.P.D of Alvas Ayurveda Medical college , and other refferals.