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CTRI Number  CTRI/2020/11/028881 [Registered on: 04/11/2020] Trial Registered Prospectively
Last Modified On: 03/11/2020
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   Study of effect of siddharthakadi lepa and vamankarma in volunteers having pimples  
Scientific Title of Study   A comparative phase II clinical study to evaluate the efficacy of Siddharthakadi Lepa and Vaman followed by Siddharthakadi Lepa in Yuvanpidika with special reference to acne vulgaris 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shraddha Dnyandev Patil 
Designation  PG student  
Affiliation  Ayurved Seva Sangh Ayurved Mahavidyalaya Nashik 
Address  OPD no 24 Department of Panchakarma

Nashik
MAHARASHTRA
422003
India 
Phone  9970620994  
Fax    
Email  shraddhupatil32@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Savita Kulkarni 
Designation  Asso Professor and Guide 
Affiliation  Ayurved Mahavidyalaya Nashik 
Address  OPD no 24 Department of Panchakarma

Nashik
MAHARASHTRA
422003
India 
Phone  9423081487  
Fax    
Email  drsavita.k07@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Savita Kulkarni 
Designation  Asso Professor and Guide 
Affiliation  Ayurved Mahavidyalaya Nashik 
Address  OPD no 24 Department of Panchakarma


MAHARASHTRA
422003
India 
Phone  9423081487  
Fax    
Email  drsavita.k07@gmail.com  
 
Source of Monetary or Material Support  
Arogyashala Rugnalaya Ganeshwadi Panchavati Nashik 
 
Primary Sponsor  
Name  Dr Shraddha Dnyandev Patil 
Address  Ayurved Seva Sangh Ayurved Mahavidyalaya Nashik 
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 Shraddha Dnyandev Patil  Arogyashala Rugnalaya Nashik  OPD no 24 Panchakarma OPD
Nashik
MAHARASHTRA 
9970620994

shraddhupatil32@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ayurved Seva Sangh ayurveda Mahavidyalaya Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Having Acne Vulgaris 
Patients  (1) ICD-10 Condition: L70||Acne,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Siddharthakadi lepa  5 gms once a day topically for 21 days after Vamankarma 
Comparator Agent  Siddharthakadi lepa  5 gms once a days topically for 21 days 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  Diagnosed subjects of Yuvanpidika with classical signs and symptoms such as Kandu Daha Ruja Srava Vaivarnya
Subjects fit for Vamankarma 
 
ExclusionCriteria 
Details  Avoid other Skin Disorder
Endocrine disorders
Genetic disorders
patient suffering from other skin diseases and systemic diseases female patients of hormonal
disorders like Hirsutism Hypogonadism 
 
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 
Reduction in signs and symptoms of acne vulgaris  30 Days 
 
Secondary Outcome  
Outcome  TimePoints 
Reduction of discoloration over the affected area   30 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   Phase 2/ Phase 3 
Date of First Enrollment (India)   23/11/2020 
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  
Acne appears on the skin as blackheads white heads pimples pustules and cysts Some factors that cause acne are some food habits diet stress hereditary drugs occupation cosmetics Acne vulgaris is a most common burning issue in the Adolscents age group The incidence of the acne vulgaris is rising tremendously now a days Face is the mirror of the individual personality and any least mark can result into a larger impact on the individuals Everyone wants to have beautiful and charming skin Change in the lifestyle and diet pattern environmental changes has increases The incidence of these diseases From the ancient time Ayurveda is known for serving the society by cure and prevention and this concept is exactly applicable on the cure and prevention of the Yuvanpidika There are number of preventives curative aspect lepa medicinal drugs and preparations described in the Ayurveda having wonderful effect on these diseases Though  several Ayurveda texts such as Sushruta Samhita Ashtanga Hrudaya  etc have elaborated the pathophysiology and treatment of acne the available references are scattered Thus there is need of in depth review and compilation of Ayurvedic texts and literatures So this study is useful in treating Yuvanpidika So i select the topic of yuvanpidika applying lepa externally on face  5 gm of Siddharthakadi Churna into sufficient quantity of water and vaman karma is internally
 
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