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CTRI Number  CTRI/2024/10/075948 [Registered on: 25/10/2024] Trial Registered Prospectively
Last Modified On: 24/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Randomized controlled clinical study to evaluate the efficacy of Durvadi Lepa in Pama w.s.r. to Scabies in children. 
Scientific Title of Study   Randomized controlled clinical study to evaluate the efficacy of Durvadi Lepa in Pama w.s.r. to Scabies in children. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Rushikesh Shivaji Dhobale 
Designation  PG SCHOLAR 
Affiliation  CSMSS AYURVED MAHAVIDYALAYA AURANGABAD 
Address  CSMSS Ayurved Mahavidyalaya and Rugnalaya 431002 Aurangabad Maharashtra India
OPD No. 14, Balroga Department,CSMSS Ayurved Mahavidyalaya and Rugnalaya 431002 Aurangabad Maharashtra India
Aurangabad
MAHARASHTRA
431002
India 
Phone  7083548080  
Fax    
Email  rushikeshdhobale@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  KS Ratanparkhi 
Designation  HOD PROFESSOR 
Affiliation  CSMSS AYURVED MAHAVIDYALAYA AURANGABAD 
Address  CSMSS Ayurved Mahavidyalaya and Rugnalaya 431002 Aurangabad Maharashtra India
OPD NO.14, Balroga DEpartment,CSMSS Ayurved Mahavidyalaya and Rugnalaya 431002, Aurangabad Maharashtra India.
Aurangabad
MAHARASHTRA
431002
India 
Phone  9421771722  
Fax    
Email  karunaratnaparkhi@gmail.com  
 
Details of Contact Person
Public Query
 
Name  KS Ratanparkhi 
Designation  HOD PROFESSOR 
Affiliation  CSMSS AYURVED MAHAVIDYALAYA AURANGABAD 
Address  CSMSS Ayurved Mahavidyalaya and Rugnalaya 431002 Aurangabad Maharashtra India
CSMSS Ayurved Mahavidyalaya and Rugnalaya 431002 Aurangabad Maharashtra India
Aurangabad
MAHARASHTRA
431002
India 
Phone  9421771722  
Fax    
Email  karunaratnaparkhi@gmail.com  
 
Source of Monetary or Material Support  
CSMSS Ayurveda Mahavidyalaya, Kanchanwadi, Paithan Road, Aurangabad 431002. 
 
Primary Sponsor  
Name  Rushikesh Shivaji Dhobale 
Address  CSMSS Ayurved Mahavidyalaya and Rugnalaya,Aurangabad 431002,Maharashtra,India 
Type of Sponsor  Other [] 
 
Details of Secondary Sponsor  
Name  Address 
CSMSS AYURVED MAHAVIDYALAYA  CSMSS Ayurved Mahavidyalaya and Rugnalaya 431002 Aurangabad Maharashtra India 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrRushikesh Dhobale   CSMSS Ayurved mahavidyalaya  OPD NO 14, Kaumarbhritya Deparment, CSMSS Ayurved Mahavidyalaya and Rugnalaya, Aurangabad 431002,Maharashtra India.
Aurangabad
MAHARASHTRA 
7083548080

rushikeshdhobale@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Chhtrapati Shahu Maharaj Sikshan Sanstha Institunal Ethical Commitee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L088||Other specified local infections of the skin and subcutaneous tissue. Ayurveda Condition: PIDAKA,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Durvadi Lepa, Reference: Sharangdhar samhita, Route: Topical, Dosage Form: Lepa Churna, Dose: 20(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 14 Days, anupAna/sahapAna: No, Additional Information: -
2Comparator Arm (Non Ayurveda)-Premethrin 5% lotion
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  15.00 Year(s)
Gender  Both 
Details  children diagnosed as the case of pama
children having pama without secondary infection 
 
ExclusionCriteria 
Details  patients suffering from any other systemic disorder congenital anomalies immune deficiency disorder and inborn errors of metabolism
kustha other than pama
pama with secondary infection 
 
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 
kandu,toda at day 1st,7th,14  Baseline 1st,7th ,14th 
 
Secondary Outcome  
Outcome  TimePoints 
pitika varna , daha at day 1st,7th,14th  Baseline 1st,7th ,14th 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   14/11/2024 
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  
Ayurveda is ancient medical science, which guide’s us about all aspects of life in health and disease. Kaumarbharitya, one among the ashtanga’s of ayurveda (8 branches of Ayurveda) has its recognition as important branch of medicine as per Kashyapa. Ayurveda has given importance to skin diseases since the era of Vedas and later on Samhita kala. The study of skin disease were done elaborately and separate chapter on Kushtha found the place. Skin disease in Ayurveda are described as Kushthroga disease. There are seven MahaKushtha and eleven number of Shudra Kushtharoga are explained. All Kushtharoga are Tridoshaja in nature but according to dominancy of Dosha’s they can be classified according to dosha. Pama Kushtha is one of the ShudraKushtha, Which is explained both in Brihatrayi and Laghutrayi. In Pama Pitta-Kapha is dominating. It is contagious and widely spreader disease throughout world. PamaKushtha is characterized by many small Pitika’s (ulcer), Toda (pricking sensation),Daha(burning sensation) and Kandu (itching).Pama may be considered as scabies in contemporary science. Human scabies is intensely pruritic skin infection caused by the host specific mite SARCOPTS SACABIEI HOMINIS. It is highly contagious, neglected cutaneous parasite disease, associated with poor individuals community, environmental circumstances and health.
 RATIONALE OF STUDY
 India is being a developing country, much population is living in lower socioeconomic class more over 90% of population live in rural area. Most of the Children’s are not conscious about their health and personal hygiene which lead to many systemic diseases like skin diseases, tuberculosis, cholera etc.{2} Pama is highly contagious, intensively pruritic. It may spread in a group of population within a short period of time due to close contact or skin to skin contact and contaminated clothes. It is found that "Pama" Vyadhi is one of the commonest diseases found in the low socioeconomic class and occurs in person do not follow guidelines of hygiene. Sign, symptom, pathogenesis and treatment of Pama are very well described in Ayurvedic texts which can correlate with scabies in modern paediatrics. This indicates that disease is one of the types of Kushtha. So far no study has been conducted for evaluation of Durvadi lepa in above problem. Therefore, this study was conducted to evaluate the efficacy of Durvadi lepa in the management of Pama
 
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