CTRI Number |
CTRI/2025/05/086266 [Registered on: 05/05/2025] Trial Registered Prospectively |
Last Modified On: |
02/05/2025 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Ayurveda |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
A comparative study of external application of Shrungaveradi Lepa and Edgajadi Lepa in 72 patients of Dadru Kushtha a skin disease known as tinea corporis |
Scientific Title of Study
|
An Open Randomised Comparative Clinical Study of Shrungaveradi Lepa and Edgajadi Lepa in the Management of Dadru Kushtha with Special Reference to Tinea Corporis. |
Trial Acronym |
Nil |
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Umesh Ganeshrao Ghuge |
Designation |
PG Scholar |
Affiliation |
APMS Ayurved Mahavidyalaya, Sion |
Address |
Department of Kayachikitsa, 4th floor, APMS Ayurved Mahavidyalaya, near Sion railway station, Sion East, Mumbai 22 Department of Kayachikitsa, 4th floor, APMS Ayurved Mahavidyalaya, near Sion railway station, Sion East, Mumbai 22 Mumbai MAHARASHTRA 400022 India |
Phone |
9881094175 |
Fax |
|
Email |
umeshghuge2208@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Umesh Ganeshrao Ghuge |
Designation |
PG Scholar |
Affiliation |
APMS Ayurved Mahavidyalaya, Sion |
Address |
Department of Kayachikitsa, 4th floor, APMS Ayurved Mahavidyalaya, near Sion railway station, Sion East, Mumbai 22 Department of Kayachikitsa, 4th floor, APMS Ayurved Mahavidyalaya, near Sion railway station, Sion East, Mumbai 22 Mumbai MAHARASHTRA 400022 India |
Phone |
9881094175 |
Fax |
|
Email |
umeshghuge2208@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Hemant Shridhar Paradkar |
Designation |
Associate Professor |
Affiliation |
APMS Ayurved Mahavidyalay, Sion |
Address |
Department of Kayachikitsa, 4th floor, APMS Ayurved Mahavidyalaya, near Sion railway station, Sion East, Mumbai 22
Mumbai MAHARASHTRA 400022 India |
Phone |
9987519315 |
Fax |
|
Email |
hemant.paradkar@gmail.com |
|
Source of Monetary or Material Support
|
APMs Ayurved Mahavidyalaya and Seth R V Ayurvedic Hospital |
|
Primary Sponsor
|
Name |
Seth RV Ayurved Hospital |
Address |
Near Sion Railway Station, Sion East, Mumbai 400022 |
Type of Sponsor |
Other [Charitable Ayurvedic Hospital] |
|
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 Umesh Ganeshrao Ghuge |
Seth RV Ayurvedic Hospital |
Deparetment of Kayachikitsa 4th Floor AMPS Ayurved Mahavidyalaya, Near Sion Railway Station, Sion East, Mumbai 22 Mumbai MAHARASHTRA |
9881094175
umeshghuge2208@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
APMS Ayurved Mahavidyalaya, Sion |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition:B354||Tinea corporis. Ayurveda Condition: DADRU-KUSHTHAH, |
|
Intervention / Comparator Agent
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | 1 | Intervention Arm | Procedure | - | lepa, लेप | (Procedure Reference: Sharangdhar Samhita-Uttarkhand /11/71-76,, Procedure details: Dry Sukshmachurna is prepared by taking equal quantities of Sunthi, Vidanga, Kushtha, & Tagar, and mixing them thoroughly. After the herbs are combined, Gomutra (cow urine) is added to the Churna mixture and Applied on skin.) (1) Medicine Name: Shrungaveradi Lepa, Reference: Gadnighrah 36/159, Route: Topical, Dosage Form: Lepa Churna, Dose: 5(g), Frequency: bd, Duration: 21 Days | 2 | Comparator Arm | Procedure | - | lepa, लेप | (Procedure Reference: Sharangdhar Samhita-Uttarkhand /11/71-76, Procedure details: Dry Sukshmachurna of Chakramarda, Kustha, Sendhav, Sarshap, Vidang will be taken in equal quantity, mixed thoroughly & macerated with Sauveerkam twice And applied on skin.) (1) Medicine Name: Edgajadi lepa, Reference: Charak Chikitsasthan 7/126, Route: Topical, Dosage Form: Lepa Churna, Dose: 5(g), Frequency: bd, Duration: 21 Days |
|
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
Age 18 to 60 years
Sex All genders
Patient with signs and symptoms of Dadru Kushtha Tinea corporis like Kandu Raga Pidaka and udgat mandala
Patient understanding and willing to sign the informed consent form
Area of largest lesion 25cm square.
|
|
ExclusionCriteria |
Details |
Patient having skin lesions other than Dadru kushtha Tinea corporis like Eczema psoriasis and urticaria
Pregnancy and lactating mother
Known case of AIDS
HIV Positive and Hepatitis B
|
|
Method of Generating Random Sequence
|
Random Number Table |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
Kandu – Itching
Raga - Erythema
Pidaka – papule
Daha - burning
Size and Number of Lesions in specific areas of the body.
|
Three weeks
|
|
Secondary Outcome
|
Outcome |
TimePoints |
nil |
nil |
|
Target Sample Size
|
Total Sample Size="72" Sample Size from India="72"
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/ Phase 4 |
Date of First Enrollment (India)
|
03/06/2025 |
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
|
The primary purpose of this open randomized
comparative clinical study is to evaluate and compare the efficacy of
Shrungaveradi Lepa and Edgajadi Lepa in the management of Dadru Kushtha - Tinea
Corporis, a superficial fungal infection of the skin characterized by itching-
kandu, redness -raga, eruptions - pidaka, and raised patches -udgat mandala.
According to Ayurveda, Dadru is classified under Kushtha and is associated with
Kapha and Pitta dosha imbalances, affecting the skin, blood, muscle, and lymph
tissues. In contemporary understanding, Tinea Corporis is a dermatophyte
infection commonly affecting adults, especially those exposed to warm, moist
conditions. The study involves a total of 72 patients, divided equally into two
groups 36 each, with a treatment duration of 21 days. Each formulation is
applied locally at a dose of 200 mg per square cm twice daily. The primary
hypothesis states that both Shrungaveradi Lepa and Edgajadi Lepa are equally
effective, however secondary hypotheses explore whether one may be superior.
The study aims to scientifically validate the traditional Ayurvedic topical
therapy, offering a potential evidence-based alternative for managing
superficial fungal infections. |