| CTRI Number |
CTRI/2024/12/077623 [Registered on: 03/12/2024] Trial Registered Prospectively |
| Last Modified On: |
02/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Shrungberadi lepa in the management of Dadru kushta |
|
Scientific Title of Study
|
Single arm clinical study to assess the efficacy of Shrungberadi lepa in the management of Dadru kushta with special reference to Fungal Dermatophytes |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rushikesh Bajarang Patil |
| Designation |
PG Scholar |
| Affiliation |
LRP Ayurvedic medical college and hospital PG Institute and Research center Urun Islampur Sangli |
| Address |
OPD no 1 Kayachikitsa Department LRP Ayurvedic medical college and hospital PG Institute and Research center Urun Islampur
Sangli
Sangli
MAHARASHTRA
415409
India |
| Phone |
8888663004 |
| Fax |
|
| Email |
rpatil95918494@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abhinandan Patil |
| Designation |
Professor |
| Affiliation |
LRP Ayurvedic medical college and hospital PG Institute and Research center Urun Islampur Sangli |
| Address |
OPD no 1 Kayachikitsa Department LRP Ayurvedic medical college and hospital PG Institute and Research center Urun Islampur
Sangli
Sangli
MAHARASHTRA
415409
India |
| Phone |
9890205000 |
| Fax |
|
| Email |
drabhinandanpatil@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abhinandan Patil |
| Designation |
Professor |
| Affiliation |
LRP Ayurvedic medical college and hospital PG Institute and Research center Urun Islampur Sangli |
| Address |
OPD no 1 Kayachikitsa Department LRP Ayurvedic medical college and hospital PG Institute and Research center Urun Islampur
Sangli
Sangli
MAHARASHTRA
415409
India |
| Phone |
9890205000 |
| Fax |
|
| Email |
drabhinandanpatil@gmail.com |
|
|
Source of Monetary or Material Support
|
| Loknete Rajarambapu Patil Ayurvedic medical college hospital post graduate institute and research center Islampur 415409 |
|
|
Primary Sponsor
|
| Name |
Rushikesh Bajarang Patil |
| Address |
OPD no 1 Kayachikitsa Department LRP Ayurvedic medical college and hospital PG Institute and Research center Urun Islampur
Sangli |
| 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 |
| self |
LRP Ayurvedic medical college and hospital PG Institute and Research center Urun Islampur 415 409 |
OPD no 1 Kayachikitsa department
Sangli
MAHARASHTRA |
8888663004
rpatil95918494@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical commitee LRP Ayurvedic medical college and hospital and PCT and RC Approved |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L00-L08||Infections of the skin and subcutaneous tissue. Ayurveda Condition: KUSHTHAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Shrugberadi lepa, Reference: Gadanigrah Dvitiya Khand 36/159, Route: Topical, Dosage Form: Lepa Churna, Dose: 1(NA), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
a) As per sign and symptoms mentioned in Ayurved samhita patient will be diagnosed as a dadru kushta
b) Gender Irrespective of gender and socioeconomic status
c) Age above 18 upto 60 yrs
d) Mandal size less than 12cm in length and less than 12cm in breadth
e) Mandal less than 10 in number |
|
| ExclusionCriteria |
| Details |
a) Pregnant and lactating women
b) Less than age 18 yrs & more than 60 yrs
c) Mandal with secondary infection immuno suppressive & other systemic disorder
d) Mandal associated with other skin diseases like psoriasis
e) Mandal more than 10 in number
f) Mandal measuring above 12cm in length and above 12cm in breadth
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the effect of Shrungberadi lepa in management of Dadru Kushta |
21 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) To study Dadru kushta in Ayurvedic perspective
2) To study Shrungberadi lepa in detail in Dadru kushta
3) To study efficacy of Shrungberadi lepa in Dadru kushta
4) To study fungal dermatophytes according to modern perspective |
12 Months |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
15/12/2024 |
| 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
|
The most exposed part of the body is skin. So, it is easily prone to various type
of infection.
Skin infection is termed as twak vikar or kusht rog in Ayurveda. Dadru kushta is
explained under heading kshudra kushta by acharya Charak and mahakusht by
acharya Sushrut and Vagbhat.
Dadru kushta is identified by symptoms kandu(itching), raga (erythema),
pidaka(papule), mandala(circular spot). In contemporary medicine, tinea/ ringworm
which is skin fungal infection is correlated to dadru kusht due to similarities in their
sign and symptoms. Prevalance of fungal infections of skin in india is 20-25%. So
making them one of the most frequent forms of infection.
Dadru kushta is predominantly pitta kaphaj as per acharya Charak and
Vagbhat, on other hand kaphaj as per acharya Sushrut.
In ayurveda, according to acharya Sushrut bahirparimarjan type of treatment is
indicated in Dadru kushta. Therefore the lepas are applied. Local application works
faster due to physiological effect of heat on skin.
Shurngberadi lepa have been stated by vd. Shodal in Gadnigrah on Dadru
kushta. The content of this lepa having common properties of kaph prashaman,
vranropan, kushtghna, kandughna, krimighna, raktshodhak,etc.
There are number of formulations in ayurveda for treatment of dadru so that
there in an attempt to see the effect. |