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CTRI Number  CTRI/2022/11/047770 [Registered on: 29/11/2022] Trial Registered Prospectively
Last Modified On: 28/11/2022
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   Comparison of Kushthadi Lepa and Vachadi Lepa in Scabies(skin disease) in children 
Scientific Title of Study   A randomized standard controlled clinical trial to access the efficacy of Kushthadi Lepa in the management of PAMA in children. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Kadambari Jitendra Jadhav 
Designation  PG Scholar 
Affiliation  PDEAs College of Ayurved and Research Centre,Sector No.25 Nigdi Pradhikaran,Pune 
Address  PDEAs College of Ayurved and Research Centre,Third floor,Kaumarbhritya department Sector No.25 Nigdi Pradhikaran,Pune

Pune
MAHARASHTRA
411044
India 
Phone  9890752074  
Fax    
Email  kadambarijadhav111@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Madhavi Sanjay Deodas 
Designation  Professor and HOD 
Affiliation  PDEAs College of Ayurved and Research Centre,Sector No.25 Nigdi Pradhikaran,Pune 
Address  PDEAs College of Ayurved and Research Centre,Third floor,Kaumarbhritya department Sector No.25 Nigdi Pradhikaran,Pune

Pune
MAHARASHTRA
411044
India 
Phone  9423010818  
Fax    
Email  drdeodasms@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Kadambari Jitendra Jadhav 
Designation  PG Scholar 
Affiliation  PDEAs College of Ayurved and Research Centre,Sector No.25 Nigdi Pradhikaran,Pune 
Address  PDEAs College of Ayurved and Research Centre,Third floor,Kaumarbhritya department Sector No.25 Nigdi Pradhikaran,Pune

Pune
MAHARASHTRA
411044
India 
Phone  9890752074  
Fax    
Email  kadambarijadhav111@gmail.com  
 
Source of Monetary or Material Support  
PDEAs College of Ayurved and Research Centre Sector No.25 Nigdi Pradhikaran,Pune 411044 
 
Primary Sponsor  
Name  PDEAs College of Ayurved and Research Centre Sector No.25 Nigdi Pradhikaran,Pune 411044 
Address  PDEAs College of Ayurved and Research Centre,Sector No.25 Nigdi Pradhikaran,Pune 411044 
Type of Sponsor  Private medical college 
 
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 Kadambari  Ayurved Rugnalay and Sterling Multispeciality Hospital  Balrog OPD Number 118, Ground floor, Sector number 27,Pradhikaran, Nigdi, Pune 411044
Pune
MAHARASHTRA 		 9890752074

kadambarijadhav111@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L208||Other atopic dermatitis. Ayurveda Condition: PAMA (KACCU),  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Kushthadi Lepa, Reference: च.चि.७/९३, Route: Topical, Dosage Form: Lepa Churna, Dose: 20(g), Frequency: tds, Bhaishajya Kal: Muhurmuhu, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: NA
2Comparator ArmDrugClassical(1) Medicine Name: Vachadi Lepa, Reference: Sushrut Sahita Chapter number 20, Route: Topical, Dosage Form: Lepa Churna, Dose: 20(g), Frequency: tds, Bhaishajya Kal: Muhurmuhu, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: NA
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  14.00 Year(s)
Gender  Both 
Details  1) Patient who will be clinically with two or more symptoms - itching, pain, burning, eruption, discharge.
2) Selection will be irrespective of gender, religion, and socio-economic class, age between 3 to 14 years. 
 
ExclusionCriteria 
Details  1) Patient suffering from any other systemic disorders such as Skin TB, Leprosy.
2) Pama associated with immune deficiency disorder such as HIV.
3) Scabies with crust or hyperkeratosis and secondary infection, urticaria etc.
4) Suspected patient for Covid-19. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To study efficacy of Kushthadi Lepa and Vachadi Lepa in PAMA (Scabies)  7 days with follow up on 3rd 5th and 7th day 
 
Secondary Outcome  
Outcome  TimePoints 
To observe the adverse effect of the drug  7 days with follow up on third and fifth day 
 
Target Sample Size   Total Sample Size="64"
Sample Size from India="64" 
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)   01/12/2022 
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   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
Scabies is one of the most common complaints in children seen all over world causing much discomfort in children. Skin diseases have high prevalence throughout the world. Scabies is caused by burrowing and release of toxic or antigenic substances by the female mite sarcoptes scabiei var hominis. Scabies is contagious and can spread through close physical contact so it is an acute communicable disease and highly prevalent in young children.
Scabies is major public health problem with an estimated prevalence of 130 million cases worldwide. The prevalence varies from 0.35 to 46%. The highest rates are found in countries with hot tropical climates where infestation is endemic. The point population in the general population of rural India is about 13%, in Maharashtra 81%, in rural area 72% of cases are seen in the age group below 16 years.
According to modern treatment permethrin 5% cream applied on entire body for scabies. Additional therapies include sulphur ointment 5-10% and crotamiton 10% lotion.
Skin disease in Ayurveda is described as Kushtha roga. There are seven Mahakushtha and eleven number of Kshudra Kushta roga explained. All Kushtha are tridoshaja but they are classified according to Dosha. Pama kushtha is one of the kshudra roga in which Pitta-Kapha is predominating. Pama Kushtha characterized by many small pitika, srava, kandu, toda and daha that may be considered as scabies in contemporary science. It is found that ’PAMA’ Vyadhi Is one of the commonest diseases found in the low-socio economic class and occurs in person who does not follow hygiene. Signs, symptoms, pathogenesis and treatment of Pama are very well described in Ayurvedic texts and there are various Kalpa described in samhitas in Ayurvedic texts.
i.e Kushthadi Lepa is used and the topic is selected.

 
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