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CTRI Number  CTRI/2025/02/081233 [Registered on: 24/02/2025] Trial Registered Prospectively
Last Modified On: 21/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To see the effect of Nava Kashaya in the treatment of tinea infection  
Scientific Title of Study   Randomized controlled clinical trial to evaluate the efficacy of Nava kashaya in the management of Dadru kushtha w.s.r. to 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  Dr Shubham Sunil Bhusal  
Designation  PG Scholar MD Kayachikitsa  
Affiliation  Dr VJD Gramin Ayurved Mahavidyalaya  
Address  OPD No. 3 Department of Kayachikitsa Dr VJD Gramin Ayurved Mahavidyalaya Patur Tq-Patur Dist-Akola Maharashtra India 444501

Akola
MAHARASHTRA
444501
India 
Phone  9588673990  
Fax    
Email  bhusalshubham@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ashish Keche 
Designation  Associate Professor  
Affiliation  Dr VJD Gramin Ayurved Mahavidyalaya  
Address  OPD No. 3 Department of Kayachikitsa Dr VJD Gramin Ayurved Mahavidyalaya Patur Tq-Patur Dist-Akola Maharashtra India 444501

Akola
MAHARASHTRA
444501
India 
Phone  8149921892  
Fax    
Email  rajeashish09@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Ashish Keche 
Designation  Associate Professor  
Affiliation  Dr VJD Gramin Ayurved Mahavidyalaya  
Address  OPD No. 3 Department of Kayachikitsa Dr VJD Gramin Ayurved Mahavidyalaya Patur Tq-Patur Dist-Akola Maharashtra India 444501

Akola
MAHARASHTRA
444501
India 
Phone  8149921892  
Fax    
Email  rajeashish09@gmail.com  
 
Source of Monetary or Material Support  
Dr VJD Gramin Ayurved Mahavidyalaya and attached Hospital,Patur,Akola, Maharashtra, India 444501 
 
Primary Sponsor  
Name  Department of Kayachikitsa Dr VJD Gramin Ayurved Mahavidyalaya near Renuka Mata Mandir Patur Akola 
Address  Dr VJD Gramin Ayurved Mahavidyalaya near Renuka Mata Mandir Patur Tq- Patur Dist-Akola Maharashtra India 444501 
Type of Sponsor  Research institution and hospital 
 
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 
Dr Shubham Sunil Bhusal   Dr VJD Gramin Ayurved Mahavidyalaya and Hospital and Research Centre   OPD No3 Department of kayachikitsa Dr VJD Gramin Ayurved Mahavidyalaya near Renuka mata mandir Patur Tal-Patur Dist-Akola
Akola
MAHARASHTRA 		 9588673990

bhusalshubham@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Dr VJD Gramin Ayurved Mahavidyalaya Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:B354||Tinea corporis. Ayurveda Condition: DADRU-KUSHTHAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Navakashaya, Reference: Chakradatta kushtha chikitsa 50/58, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 30(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -koshnajal ), Additional Information: -
2Comparator ArmDrugClassical(1) Medicine Name: Laghumanjisthadi kwatha, Reference: Bhavprakash madhyam Khand 54 , Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 30(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -koshnajal ), Additional Information: -
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1) Subjects with classical sign & symptoms of Dadru i.e. Kandu, Pidikotpatti,
Raga, Utsanna mandala.
2) Subjects of either gender and age group between 20-60 years irrespective
of religion, occupation and socio-economic status will be selected.
3) Subjects having symptoms of dadru kushtha within the time period of 6
month 
 
ExclusionCriteria 
Details  1) Subjects of Dadru with any secondary complication.
2) Subjects who are suffering from any other type of skin disease like Herpes
zoster, eczema.
3) Subjects who are suffering from Onychomycosis(fungal infection of nail).
4) Subjects who are suffering from any other known case of systemic
Diseases i.e. Uncontrolled DM etc.
5) Pregnant and lactating women.
6) Subjects taking immunosuppressive medications.
7) Patients under age of 20 years and above 60 years.
8) Patients not willing. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. Kandu (Itching)
2. Pidika (Eruption)
3.Raga (Erythema or Redness)
4.Utsanna Mandala (Elevated skin lesion) 		 15th,30th,45th day 
 
Secondary Outcome  
Outcome  TimePoints 
Decreases in symptoms completely   18 month  
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   05/03/2025 
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   Human skin since it is the outer covering of the body, is the largest organ
of the body and therefore susceptible to a large number of infections and
diseases. Skin diseases are among the most common diseases faced by a
quite large number of populations ranging from cancerous to non cancerous
diseases .the occurrence of skin diseases varies between different continents
as people are being exposed to different causative elements. These different
skin diseases have individualized diagnosis, treatments and a unique social
stigma among the patients.
According to ayurveda skin, (twak/twacha) is one of the essential sense
organs and is considered important to know the status of dosha and dhatu in
shareera and also twak sarta and ras dhatu sarta depend on the condition of
twacha of that individual. Ayurveda has given prime importance to ahara
(diet) and vihara(lifestyle) in the maintenance of health and prevention of
diseases. In recent era, the relation between diet and skin diseases is well
established and proven in the contemporary medical science.
Ayurveda has its own unique principles of diagnosis and treatment of
various skin diseases under the heading of kustha and the literary meaning
of kustha is one that causes disfiguration. Kustha has been included in
asthamahagada diseases by our acharyas. In Ayurveda texts have described
dadru as one among the types of kustha with etiological factors including
physical, physiological, hereditary, psychological, psychosocial and
papakarma (sinful activities) which are considered as main culprits in
samprapti of dadru . Dadru is characterized by various lakshanas like kandu
(itching), raga (erythema), pidika(eruptions), utsanna mandala(elevated
circular skin lesion) and is faced by a large number of population in their lifetime and hereby taken up for the study.
Dadru can be correlated with Tinea infection described in modern science
and its prevalence rate is 4.1%.
In Ayurveda research works have been done on dadru which have mainly
emphasized on bahiparimarjan chikitsa and few works have done on
antarparimarjan chikitsa i.e shodhan and shaman . realizing the scope and
feasibility of antarparimarjan chikitsa in dadru present study has been taken
up to study the efficacy of Navakashaya in the management of dadru ( Tinea
infection).
 
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