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CTRI Number  CTRI/2025/02/079976 [Registered on: 06/02/2025] Trial Registered Prospectively
Last Modified On: 29/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Use of nirgundi leaves on tinea infection 
Scientific Title of Study   Standardization of Nirgundi ( Vitex negundo Linn.) and evaluation of its Anti-oxidant activity with special reference to Dadru ( Tinea infection ).  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrDipti Gaurav Kadam 
Designation  Associate Professor 
Affiliation  Dr.G.D.Pol Foundations YMT Ayurevd Medical College 
Address  Department of Dravyaguna 2nd floor,room no 211, Dr G D Pol Foundations YMT Ayurvedic College Institutional area Sector 4 Kharghar Navi Mumbai
Department of Dravyaguna 2nd floor, room no 211, Dr G D Pol Foundations YMT Ayurvedic College Institutional area Sector 4 Kharghar Navi Mumbai
Mumbai
MAHARASHTRA
410210
India 
Phone  09773794332  
Fax    
Email  drdiptimore@yahoo.co.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Manoj Kadam 
Designation  Professor 
Affiliation  Dr.G.D.Pol Foundations YMT Ayurvedic Medical College 
Address  Department of Dravyaguna 2nd floor, room no 211, Dr G D Pol Foundations YMT Ayurvedic College Institutional area Sector 4 Kharghar Navi Mumbai
Department of Dravyaguna 2nd floor, room no 211, Dr G D Pol Foundations YMT Ayurvedic College Institutional area Sector 4 Kharghar Navi Mumbai
Mumbai
MAHARASHTRA
410210
India 
Phone  8767091736  
Fax    
Email  drmanoj.kadam@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Jai Kini 
Designation  Director research 
Affiliation  Dr.G.D.Pol Foundations YMT Ayurvedic Medical College Kharghar 
Address  3rd floor, room no 305,Dr G D Pol Foundations YMT Ayurvedic Medical College Institutional area Sector 4 Kharghar Navi Mumbai

Mumbai
MAHARASHTRA
410210
India 
Phone  9869046901  
Fax    
Email  vd.jaikini@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Dr Dipti Gaurav Kadam 
Address  Department of Dravyaguna, 2nd floor, room no 211, Dr.G.D.Pol Foundations YMT Ayurvedic Medical College, Kharghar, Navi Mumbai-410210 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrDipti Kadam  Dr.G.D.Pol Foundations YMT Ayurved Medical College  Department of Dravyaguna,2nd floor, room no 211.
Raigarh
MAHARASHTRA 
09773794332

drdiptimore@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
EthicscommitteeYmtAyurvedic Medical College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator Arm (Non Ayurveda)-TerbinafinTab.Terbinafine 250 mg OD and Terbinafine ointment for local application ( as per the area involved)
2Intervention ArmDrugClassical(1) Medicine Name: Nirgundi, Reference: Gadanigraha, Route: Oral, Dosage Form: Churna/ Powder, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: koshna jala), Additional Information: -
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1.Patients with classical lakshanas of Dadru
2.Patients of all varieties of Tinea will be selected without discriminating its area of infection.
3.Both fresh and treated cases of Dadru will be selected. 
 
ExclusionCriteria 
Details  1.Patients suffering with systemic disorders like uncontrolled Diabetes Mellitus,Auto-Immune diseases, HIV (Clinically diagnosed) will be excluded.
2.Tinea associated with other skin diseases will be exclud.
3.Pregnant and Lactating women
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
treatment of fungal infection  baseline, 7days, 14 days,21 days 
 
Secondary Outcome  
Outcome  TimePoints 
Detailed & Scientific study of Nirgundi Vitex negundo Linn  baseline, 7days, 14 days,21 days 
 
Target Sample Size   Total Sample Size="122"
Sample Size from India="122" 
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 
Date of First Enrollment (India)   19/02/2025 
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="0"
Months="3"
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  

Tinea or ringworm is one of the most common skin disorders encountered in the clinical practice. It is a group name for a highly contagious segmented Mycelial fungus. It is a commonest single fungus group of infections found in an unhygienic conditions especially in tropical and subtropical countries, unless properly treated they become chronic. It is also prevalently seen in slum areas of Mumbai like Dharavi, Mankhurd. It affects about 35% of the population , it is equally common in men and women 1. It occurs at any age except Tinea capitis which occurs in children mainly. The modern treatment available for Tinea fungal infection gives only symptomatic relief without breaking the pathology and also gives unnecessary side effects to the patients.

               Dadru is one of the commonly occurring skin diseases which have been included under Mahakushta by Acharya Sushruta2. According to Acharya Dalhana, Dadru is of 2 types, Sitha and Asitha. Dadru Kushta is considered as one of the AsthaMahagada 3. Acharya Charaka has mentioned 18 types of Kusta which are further divided into Mahakushta and Shudrakushta. Dadru has been considered under Shudrakushta by Acharya Charaka. Dadru bears greater resemblance with Tinea.

               There are different treatment modalities which can be applied, as per the requirement of the situation. That is to say some skin conditions needs shodhana, some needs only shamana, some requires repeated shodhana, raktamokshana etc..,Dadru/Tinea is a condition again where all the treatment modalities can be applied. 

            Nirgundi(Vitex negundo Linn.) has been described by various Acharya, Nighantu grantha as well as Modern Ayurvedic texts.In the text of  Gadanigraha,Acharya Shodhal has mentionedNirgundi ( Vitex negundo Linn) patra swarasa lepa reduces Dadru 4. It is used as Kusthaghna, Krimighna dravya in various skin disorders. Dadru is basically Kaphapitta Pradhan vyadhi. Nirgundi (Vitex negundo Linn.) is said to be Jantuhara and Kaphagna, which plays major role in Tinea infection (Dadru).

It can be assumed that Nirgundi (Vitex negundo Linn.) by its Anti-oxidant property will reduce oxidative stress in tinea fungal infection patients. Kusthaghna, Krimighanaand kaphaghana effect of Nirgundi (Vitex negundo Linn.) can improve the skin condition of patients of Tinea infection by decreasing symptoms, normalizing skin and avoiding drug dependence and adverse effect.

To anticipate the effective management of Dadru vis-à-vis   Tinea, the present study is undertaken to evaluate the effect of Nirgundi (Vitex negundo Linn.) in the management of Dadru (Tinea infection).

 
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