| CTRI Number |
CTRI/2026/03/106307 [Registered on: 16/03/2026] Trial Registered Prospectively |
| Last Modified On: |
17/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Herbal Mineral Cream for Skin Fungal Infection For Testing Its Effects on Patients with Tinea Corporis |
Scientific Title of Study
Modification(s)
|
Metabolomic And Clinical Evaluation Of A Herbomineral Formulation For Its Antidermatophytic Efficacy In 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 |
Dr Rajput Deepaksingh Mohansingh |
| Designation |
Junior Resident |
| Affiliation |
Institute Of Medical Sciences Banaras Hindu University |
| Address |
Department of Kaumarbhritya Balaroga Faculty Of Ayurveda
Institute Of Medical Science Banaras Hindu University Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
7304148003 |
| Fax |
|
| Email |
d4deepakrajput@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ravi Shankar Khatri |
| Designation |
Assistant Professor |
| Affiliation |
Institute Of Medical Sciences Banaras Hindu University |
| Address |
Department of Kaumarbhritya Balaroga Faculty Of Ayurveda
Institute Of Medical Science Banaras Hindu University Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9549182589 |
| Fax |
|
| Email |
drrskhatri@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ravi Shankar Khatri |
| Designation |
Assistant Professor |
| Affiliation |
Institute Of Medical Sciences Banaras Hindu University |
| Address |
Department of Kaumarbhritya Balaroga Faculty Of Ayurveda
Institute Of Medical Science Banaras Hindu University Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9549182589 |
| Fax |
|
| Email |
drrskhatri@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Faculty Of Ayurveda Institute Of Medical Science Banaras Hindu University Varanasi |
| Address |
Department Of Kaumarbhritya Balaroga Faculty Of Ayurveda
Institute Of Medical Science Banaras Hindu University Varanasi Uttar Pradesh 221005 |
| Type of Sponsor |
Research institution and 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 Rajput Deepaksingh Mohansingh |
Sir Sundarla Hospital Banaras Hindu University |
OPD No 25 Kaumarbhritya Balaroga OPD Department Of Kaumarbhritya Balaroga Faculty Of Ayurveda Institute Of Medical Science Banaras Hindu University Varanasi
Varanasi
UTTAR PRADESH |
7304148003
d4deepakrajput@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Banaras Hindu University Institute Of Medical Science Institutional Ethics Committee Varanasi |
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 | Drug | Other than Classical | | (1) Medicine Name: Herbomineral Cream, Reference: NA, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 0.5(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 6 Weeks, anupAna/sahapAna: No, Additional Information: Name of Intervention- Herbomineral Antifungal Cream
Type of Intervention-Pharmaceutical (Ayurvedic Herbomineral)
Details of Intervention: Topical cream containing:
1. Chakramarda (Cassia tora) - Herbal extract, 2. Karanja (Pongamia pinnata) - Herbal extract/oil, 3. Gandhaka (Purified Sulphur), 4. Karpur(Cinnamomum camphora)
Formulation Base: Aqueous cream base with suitable preservatives and excipients
Dose- Approximately 1 Finger Tip Unit (FTU) per affected lesion/area (0.5g)
Route of Administration: Topical (Cutaneous)
Frequency- Twice daily (morning and evening after cleaning the area)
Duration- 6 weeks (42 days)
Method of Application: 1. Wash and clean the affected area, 2. Take 1 FTU cream on the fingertip, 3. Gently apply a thin layer over the affected area in circular motion, 4. Do not cover with a bandage unless directed.
Quantity Guide: Face, Arm, Leg, Trunk: 1-1½ FTU, Hand, Foot: 1½ FTU, Larger areas: Proportionate increase | | 2 | Comparator Arm (Non Ayurveda) | | - | Clotrimazole cream | Name of Intervention: Clotrimazole 1% Cream
Type of Intervention: Pharmaceutical (Allopathic)
Details of Intervention: Clotrimazole 1% w/w topical cream (Standard antifungal cream, e.g., Candid Cream or equivalent)
Dose: 1 Finger Tip Unit (FTU) 0.5g per affected lesion/area
Route of Administration: Topical (Cutaneous)
Frequency: Twice daily (morning and evening)
Duration: 6 weeks (42 days)
Method of Application: 1. Wash and clean the affected area, 2. Take 1 FTU cream on the fingertip, 3. Gently apply a thin layer over the affected area in circular motion, 4. Do not cover with a bandage unless directed.
Quantity Guide: Face, Arm, Leg, Trunk: 1-1½ FTU, Hand, Foot: 1½ FTU, Larger areas: Proportionate increase |
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Month(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients Diagnosed With Tinea Corporis
2. Patients With Mild To Moderate case of Tinea Corporis
3. Parents Submit Written Consent To Participate In The Study
|
|
| ExclusionCriteria |
| Details |
1. Patients With Hemorrhagic Pustular And Vesicular Rashes
2. Patients Who Refuse For Investigations On Follow Up Were Dropped From The Study
3. Patients With Any Acute Systemic Illness
4. Patient That Are Using Systemic Steroids
5. Patients Suffering From Any Life Threatening Conditions
6. Patients Showing Signs Of Intolerance To The Formulation |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Complete resolution of all signs and symptoms of Tinea corporis (erythema, scaling, itching, vesiculation) with no visible lesion
2. Negative potassium hydroxide (KOH) microscopy AND negative fungal culture from lesion scrapings. |
Baseline (Day 0), 2nd Week, 4th Week And 6th Week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Patient satisfaction and improving quality of life
2. To establish the safety and efficacy of the study product
3. No recurrence of symptoms after cessation of therapy |
Baseline (Day 0) and End of Study (6th Week) |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
14/04/2026 |
| 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 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
|
Dermatophytosis- It is a fungal infection of the
skin, hair, and nails caused by dermatophytes, a group of fungi that thrive on
keratin. Common dermatophyte species include Trichophyton, Microsporum, and
Epidermophyton. These infections are typically classified based on the affected
area, such as tinea corporis (body), tinea cruris (groin), tinea pedis (foot),
tinea capitis (scalp), and tinea unguium (nails). Dermatophytes are transmitted through direct contact with infected
individuals, animals, or contaminated surfaces.
Itching,
redness, and scaly patches on the skin are common symptoms.In Ayurveda it can
be correlated with Dadru kustha |