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CTRI Number  CTRI/2024/12/077996 [Registered on: 12/12/2024] Trial Registered Prospectively
Last Modified On: 11/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study to compare the effect of patoladi kashay and laghumanjishthadi kashay in combination with durvadi lepa in the management of dadru kushtha. 
Scientific Title of Study   A randomised clinical study to evalluate efficacy of patoladi kashay and laghumanjishthadi kashay in combination with durvadi lepa in the management of dadru kushtha. 
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 Jidnya Rajendra Retharekar 
Designation  PG scholar 
Affiliation  Seth Govindaji Raoji Ayurveda Mahavidyalaya 
Address  Seth Sakharam Nemchand Jain Ayurveda Rugnalaya 118/119 Shukrawar peth near juni faujdar chawadi Solapur MAHARASHTRA 413002

Solapur
MAHARASHTRA
413002
India 
Phone  9359644088  
Fax    
Email  jidnya99@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vivek S Chandurkar 
Designation  HOD Kayachikitsa Department 
Affiliation  Seth Govindaji Raoji Ayurveda Mahavidyalaya 
Address  Seth Sakharam Nemchand Jain Ayurveda Rugnalaya 118/119 Shukrawar peth near juni faujdar chawadi Solapur MAHARASHTRA 413002

Solapur
MAHARASHTRA
413002
India 
Phone  9422788569  
Fax    
Email  vivek.chandurkar@sgrayurved.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Jidnya Rajendra Retharekar 
Designation  PG scholar 
Affiliation  Seth Govindaji Raoji Ayurveda Mahavidyalaya 
Address  Seth Sakharam Nemchand Jain Ayurveda Rugnalaya 118/119 Shukrawar peth near juni faujdar chawadi Solapur MAHARASHTRA 413002

Solapur
MAHARASHTRA
413002
India 
Phone  9359644088  
Fax    
Email  jidnya99@gmail.com  
 
Source of Monetary or Material Support  
Seth Sakharam Nemchand Jain Ayurveda Rugnalaya 118/119 shukrawar peth near juni faujdar chawdi Solapur MAHARASHTRA 413002 India 
 
Primary Sponsor  
Name  Dr Jidnya Rajendra Retharekar 
Address  Seth Sakharam Nemchand Jain Ayurveda Rugnalaya 118/119 shukrawar peth near juni faujdar chawdi Solapur MAHARASHTRA 413002 India 
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 
Dr Jidnya Rajendra Retharekar  Seth Sakharam Nemchand Jain Ayurveda Rugnalaya   Kayachikitsa OPD NO 2 3 Seth Sakharam Nemchand Jain Ayurveda Rugnalaya 118/119 shukrawar peth near juni faujdar chawdi Solapur MAHARASHTRA 413002 India
Solapur
MAHARASHTRA 		 09359644088

jidnya99@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Seth Govindaji Raoji Ayurveda Mahavidyalaya  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L00-L08||Infections of the skin and subcutaneous tissue. Ayurveda Condition: DADRU-KUSHTHAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: patoladi kashay, Reference: ashtang hriday, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 48(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: -
2Intervention ArmDrugClassical(1) Medicine Name: laghumanjishthadi kashay, Reference: bhavprakash, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 48(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 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 18 to 70 yrs 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 who are suffering from any other type of skin disease like Herpes zoster, eczema.
2. Subjects who are suffering from any other known case of systemic Diseases i.e. Uncontrolled Diabetes Mellitus etc.
3. Pregnant and lactating women.
4. Subjects taking immunosuppressive medications. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate the efficacy of Patoladi Kashay with Durvadi Lepa in management of Dadru kushtha   45 days 
 
Secondary Outcome  
Outcome  TimePoints 
To understand in detail Samprapti of Dadru Kushtha.  45 days 
 
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)   22/12/2024 
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               Skin is largest organ and outermost covering of human body. Because skin interfaces with the environment, it plays an important role in protecting body against pathogens and other environmental conditions. In Ayurveda, skin diseases are explained under heading Kushtha which is considerd one among the Asthaumahagada. Lasika, Rakta, Mansa Dhatu, Twacha are Dushya involve in Kushtha. They are further classified into Mahakushtha and Kshudrakushtha. Acharya Charak has included Dadru in Kshudrakushtha. Acharya Vagbhat and Acharya Sushruta have explained it under Mahakushtha.. Ayurvedic Classics have considered each type of Kushta to be a Tridoshaja manifestation. Nonetheless their Doshik identity can be established on the basis of dominance of Dosha in the Samprapti.Dadru Kushtha is Pittakaphaj phenomenon9. Clinical features Dadru Kushtha are Kandu(itching) Raga(erythema), Pidika(eruption), Utsanna mandala(elevated circular skin lesion).As per modern perspective Dadru disease can be correlated as “Superficial fungal infection of skin”. WHO states the prevalence of superficial mycotic infections between 20%-25%. Combination of the formulation Patoladi Kashay mentioned in Ashtang Hridaya as Shaman Aushadhi and Durvadi Lepa mentioned in Chakradatta as Bahiparimarjana Chikitsa has been selected for present study which is compaired with combination of Laghumanjisthadi Kwath mentioned in Bhavaprakash as Shaman Aushadhi and Durvadi Lepa mentioned in as Bahiparimarjana Chikitsa.dosage of internal medicine is 48 ml and lepa is according to need . study duration is 45 days and followups are on 15 30 45 day. . Due to changing lifestyle, dietary inconsistencies, environmental factors like humidity the incidences of skin disease are increasing day by day.so to controll such conditions is purpose of my study. 
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