| CTRI Number |
CTRI/2024/05/067776 [Registered on: 21/05/2024] Trial Registered Prospectively |
| Last Modified On: |
26/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Exploring the Relationship Between Dadru Kustha and Fungal Dermatophytes in Participants and A Comparative Trial with Interventions of Dadruhar Lepa and Durvadi Lepa |
|
Scientific Title of Study
|
An Observational Study To Determine Relation Between Dadru Kustha and Fungal Dermatophytes and Randomized Clinical Comparative Trial Of Dadruhar Lepa And Durvadi Lepa |
| 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 Sudeeksha Verma |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Ayurveda |
| Address |
Department of Roga Nidana evum Vikriti Vigyana, OPD Room no. 17 National Institute of Ayurveda, Jorawar Singh Gate, Amer Road, Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
8949643931 |
| Fax |
|
| Email |
269verma@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prashant Nareshrao Deshmukh |
| Designation |
Assistant Professor |
| Affiliation |
National Institute of Ayurveda |
| Address |
Department of Roga Nidana evum Vikriti Vigyan OPD Room no 17 and Central Lab, National Institute of Ayurveda, Jorawar Singh Gate, Amer Road, Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
9736824325 |
| Fax |
|
| Email |
dr.deshmukhpn12@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prashant Nareshrao Deshmukh |
| Designation |
Assistant Professor |
| Affiliation |
National Institute of Ayurveda |
| Address |
Department of Roga Nidana evum Vikriti Vigyan OPD Room no 17 and Central Lab, National Institute of Ayurveda, Jorawar Singh Gate, Amer Road, Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
9736824325 |
| Fax |
|
| Email |
dr.deshmukhpn12@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Ayurveda, Jorawar Singh Gate, Amer Road, Jaipur, Rajasthan 302002, INDIA |
|
|
Primary Sponsor
|
| Name |
National Institute of Ayurveda |
| Address |
Jorawar Singh Gate, Amer Road, Jaipur, Rajasthan |
| Type of Sponsor |
Government medical college |
|
|
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 Sudeeksha Verma |
National Institute of Ayurveda, Jaipur |
Department of Roga Nidana evum Vikriti Vigyan OPD Room no 17 and Central Lab of National Institute of Ayurveda, Jorawar Singh Gate, Amer Road, Jaipur
Jaipur
RAJASTHAN |
8949643931
269verma@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee National Institute Of Ayurveda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:B359||Dermatophytosis, unspecified. 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: DADRUHARA LEPA, Reference: NA, Route: Oral, Dosage Form: Lepa Churna, Dose: 10(g), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: DURVADI LEPA, Reference: Bhaisajya Ratnawali 14/54, Route: Topical, Dosage Form: Lepa Churna, Dose: 10(g), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: .30 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient with classical sign and symptoms of Dadru kushtha i.e. Kandu,Raga, Pidika, Utsanna Mandal |
|
| ExclusionCriteria |
| Details |
1. The patients suffering from severe systemic disorders (e.g DM) were excluded
2. Patient less than 18 years of age and more than 70 years of age
3. Known case of any skin diseases other than Dadru
4. Case of burns
5. History of drug allergy to any of drug used in the study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Association between dadru and fungal dermatophyte by fungal culture. |
Changes will be observed in 30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Changes in signs and symptoms of dadru like no. of Mandal, size of Mandal, no. of
Pidika |
Changes will be observed in 30 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
15/06/2024 |
| Date of Study Completion (India) |
27/08/2025 |
| Date of First Enrollment (Global) |
15/06/2024 |
| Date of Study Completion (Global) |
27/08/2025 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
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
|
RESEARCH QUESTION
1. Is there any association between Dadru kushtha and fungal dermatophytes 2. Is there is difference in effect of Dadruhara lepa and Durvadi lepa in the patient on Dadru. HYPOTHESIS Null Hypothesis[H0] [HOA] - There is no association between Dadru kushtha and fungal dermatophytes. [HOB] -There is no difference in the effect of Dadruhara Lepa and Durvadi Lepa in the patient of Dadru. Alternate Hypothesis [H1] [H1A] - There is a association between Dadru kushtha and fungal dermatophytes. [H1B]-There is difference in the effect of Durvadi lepa and Dadruhara lepa in the management of Dadru . AIMS To study the association between Dadru Kushtha and fungal dermatophytes. To compare the efficacy of Dadruhara Lepa and Durvadi Lepa in management of Dadru. OBJECTIVES PRIMARY OBJECTIVE– To study association between Dadru and fungal dermatophytes by fungal culture. SECONDARY OBJECTIVES To study the efficacy of Dadruhara Lepa in management of Dadru. To study the efficacy of DurvadiLepa in management of Dadru. To study the comparative efficacy of Dadruhara Lepa and Durvadi Lepa in management of Dadru. Brief Summary: Dadru affects the population of all the age group & it stands as challenge to different medical systems. No drug has yet been claimed to cure this skin disease completely & prevent its recurrence. Long lasting usage of topical or systemic antifungal, corticosteroids may produces the adverse effect along with resistance. There are very few research has been carried out in the past which relates Dadru Kushtha with fungal dermatophytes. This calls for a need to study of Dadru Kushtha with special reference to Fungal Dermatophytes. With this study we want to find about which fungal species is more prevalant in causing Dadru Kustha ( Corelated with Fungal Dermatophytes)
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