| CTRI Number |
CTRI/2024/04/065927 [Registered on: 18/04/2024] Trial Registered Prospectively |
| Last Modified On: |
16/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Bilwadi agada followed by Nalpamaradi oil tropical application in fungal infection |
|
Scientific Title of Study
|
Effect of topical application of bilwadi agada followed by nalpamaradi taila in dadru wsr to tinea corporis: an open labelled clinical trial |
| 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 Sushma Ghoolappa Kanavi |
| Designation |
Pg Scholar dept of agada tantra |
| Affiliation |
KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya Shahapur Belagavi |
| Address |
KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya Shahapur Belagavi
Agada tantra department
OPD NO 16
Belgaum KARNATAKA 590003 India |
| Phone |
9513460380 |
| Fax |
|
| Email |
drsushmakanavi@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Rudramma R Hiremath |
| Designation |
Professor and HOD PG Department of Agada Tantra Evum Vidhivaidyaka |
| Affiliation |
KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya Shahapur Belagavi |
| Address |
KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya Shahapur Belagavi
Agada tantra department
OPD NO 16
Belgaum KARNATAKA 590003 India |
| Phone |
9480539098 |
| Fax |
|
| Email |
drrrhiremath99@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Rudramma R Hiremath |
| Designation |
Professor and HOD PG Department of Agada Tantra Evum Vidhivaidyaka |
| Affiliation |
KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya Shahapur Belagavi |
| Address |
KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya Shahapur Belagavi
Agada tantra Department
OPD NO16
KARNATAKA 590003 India |
| Phone |
9480539098 |
| Fax |
|
| Email |
drrrhiremath99@gmail.com |
|
|
Source of Monetary or Material Support
|
| KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya Shahapur Belagavi |
|
|
Primary Sponsor
|
| Name |
Dr Sushma Ghoolappa Kanavi |
| Address |
KAHREs Shri B M Kankanawadi Ayurveda Mahavidyalaya Shahapur Belagavi |
| 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 |
| Dr Sushma Ghoolappa Kanavi |
KLE Ayurveda hospital and medical research center agada tantra department OPD NO 16 |
Agada Tantra department opd no 16 Belgaum KARNATAKA |
9513460380
drsushmakanavi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committe for research on human subjects KAHEs Shri B M Kankanawadi ayurveda mahavidyalaya and KLE ayurved hospital shahapur Belagavi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L99||Other disorders of skin and subcutaneous tissue in diseases classified elsewhere. Ayurveda Condition: DADRU-KUSHTHAH, (2) ICD-10 Condition:L088||Other specified local infections 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: bilwadi agada, Reference: ashtanga uttara sthana 36 chapter84 to 85 shloka, Route: Topical, Dosage Form: Lepa Gutika, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 10 Days, anupAna/sahapAna: No, Additional Information: -total 21 days study in that first 10 days we give bilwadi agada followed by nalpamaradi taila for topical application after 10 days only nalpamardi taila for topical application(2) Medicine Name: nalpamaradi taila, Reference: sahastrayoga taila yoga prakarana 26 and AFI volume 1, Route: Topical, Dosage Form: Taila, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 5 Days, anupAna/sahapAna: No, Additional Information: -total 21 days study in that first 10 days we give bilwadi agada follo |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient diagnosed with Tinea corporis
Patients aged between 18 to 60 years
Irrespective of sex
Positive mycological findings of less than 30 Percentage of the body surface involvement will be recruited for the study
|
|
| ExclusionCriteria |
| Details |
Patients undergoing antifungal treatment
Generalized skin conditions such as herpes zoster urticaria pemphigus and psoriasis
Patient with Diabetes mellitus and uncontrolled hypertension
Systemic diseases RA Liver and renal dysfunction
Patient with the treatment of phototherapy and corticosteroids
Hypersensitive patients
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| primary outcome- decrease in fungal load from 0th day to 21st day |
0th 11th and 21st day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
KANDU Itching
RAGA Erythema
PIDAKA Eruption
ROOKSHATA Dryness
UTSANNA MANDALA Elevation of lesion
|
oth 11th & 21st day |
|
|
Target Sample Size
|
Total Sample Size="20" Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "20"
Final Enrollment numbers achieved (India)="20" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
01/05/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
Dermatophyte is a common label for a group of fungus of Arthrodermataceae family that commonly causes skin infection in humans and animals. Fungal skin infection can be superficial or less commonly deep; the latter are seen more often in tropical climates or in the immunocompromised. Dermatophyte infections are extremely common and usually caused by the fungi of the Microsporum, Trichophyton and Epidermophyton species. The fungi can originate from soil(geophilic) or animals(zoophilic) or be confined to human skin(anthropophilic). TINEA CORPORIS The site of infection is typically on exposed skin unless the infection represents an extension of a pre-existing infection. In such cases, infection may spread from the scalp, down the neck onto the upper trunk, or from the groins onto the buttocks and lower trunk. Characteristics lesions are circular, usually sharply emarginated with a raised edge. Single lesions occur or there may be multiple plaques. The latter may remain discrete or become concrescent. The degree of inflammation is roughly proportional to the extent of follicular invasion, thus tinea corporis is generally less inflammatory than tinea capitis or tinea barbae. In quieter infections scaling is common but not a constant finding. Sometimes pustules or vesicles may dominate. Central resolution in the lesions may occur but not an invariable feature of tinea corporis. |