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CTRI Number  CTRI/2023/06/053471 [Registered on: 02/06/2023] Trial Registered Prospectively
Last Modified On: 30/04/2024
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   Study of skin and comparative trial of Jatiphaladi Lepa and Phototherapy in acne.  
Scientific Title of Study   A comparative clinical trial to assess the effect of jatiphaladi lepa and phototherapy in yuvanpidaka with special reference to twak sharir 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Anjali Bhati 
Designation  PG Scholar 
Affiliation  National institute of Ayurveda deemed university Jaipur 
Address  Department of kriya sharir National institute of Ayurveda deemed university Jaipur

Jaipur
RAJASTHAN
302002
India 
Phone  7014563648  
Fax    
Email  anjalimbhati17@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Chhaju Ram Yadav 
Designation  Professor and head 
Affiliation  National institute of Ayurveda deemed university Jaipur 
Address  Room no 237 Department of kriya sharir National institute of Ayurveda deemed university Jaipur

Jaipur
RAJASTHAN
302002
India 
Phone  9460866101  
Fax    
Email  dr.yadavcr@gmail.com  
 
Details of Contact Person
Public Query  
Name  Rashmi Prakash Gurao 
Designation  Assistant Professor 
Affiliation  National institute of Ayurveda deemed university Jaipur 
Address  Room no 236A Department of kriya sharir National institute of Ayurveda deemed university Jaipur

Jaipur
RAJASTHAN
302002
India 
Phone  9284142677  
Fax    
Email  drrashmigurao@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Ayurveda, Jaipur 
 
Primary Sponsor  
Name  National Institute of Ayurveda, Jaipur 
Address  Near Jorawar singh gate Amer road Jaipur Rajasthan 
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 
Anjali Bhati  National Institute of Ayurveda Jaipur  OPD No 3 Kriya Sharir Department
Jaipur
RAJASTHAN 		 7014563648

anjalimbhati17@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee National Institute of Ayurveda  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L700||Acne vulgaris. Ayurveda Condition: YUVANAPIDAKA (MUKHADUSHIKA),  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Jatiphaladi Lepa, Reference: Yogratnakar Kshudra Roga Chikitsa122, Route: Topical, Dosage Form: Kalka/ Paste , Dose: 10(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: -
2Comparator Arm (Non Ayurveda)-PhototherapyPhototherapy- twice a week, each session for 15 minutes
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  Subjects of either sex aged between 18-40 years
Subjects with classical signs and symptoms of Yuvanpidaka
Subjects ready to give informed written consent for the trial 
 
ExclusionCriteria 
Details  Known case of any acute or chronic skin diseases chronic systemic diseases Sexually
Transmitted Diseases uncontrolled Diabetes Mellitus Hypertension and Blood
Disorders or any organ failure
Contraindications of Phototherapy like skin allergies photosensitive disorder
pregnancy breastfeeding women SLE etc
Taking any other medication for the same illness 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Change in the Global Acne Grading Score.  4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Change in signs and symptoms (Kandu, Ruja, Daha, Shrava, Snigdhata, Vaivarnya)
of Yuvanpidaka. 		 30 days 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   17/02/2024 
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="0"
Months="1"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   Not any 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

NEED OF STUDY :

Ø  Lepa is one of the modalities of treatment commonly prescribed in the management of Yuvanpidaka. Jatiphaladi Lepa is indicated in the treatment of Yuvanpidaka by Yogratnakara.

Ø  Phototherapy is the recent advancement in cosmetology used to treat mild to moderate acne outbreaks. It includes Blue and Red light therapy of a certain wavelength that kills acne-causing bacteria, without damaging the skin.

Ø  Blue light has anti-bacterial and anti-inflammatory effects while Red light has got anti-inflammatory effects and rejuvenating effects.

Ø  As blue light has more impact on Acne and Red light more on scars, in this study blue light is opted.

Ø  This study is intended to compare the effect of Jatiphaladi Lepa and Phototherapy in Yuvanpidaka.

 

AIM :

To compare the effect of Jatiphaladi Lepa & Phototherapy in Yuvanpidaka.

 

OBJECTIVES :

1.     To study the physiological concept of Twak Sharir with special reference to Yuvanpidaka.

2.     To evaluate the effect of Jatiphaladi Lepa in Yuvanpidaka. 

3.     To evaluate the effect of Phototherapy in Yuvanpidaka.

 

RESEARCH QUESTION:

·       Is there any difference in the effect of Jatiphaladi Lepa and Phototherapy in Yuvanpidaka ?

 

STATEMENT OF HYPOTHESIS :

 

Null hypothesis(H0)

There is no difference in the effects of Jatiphaladi Lepa and Phototherapy in the management of Yuvanpidaka.

 

Alternative hypothesis(H1)

There is a difference between the effects of Jatiphaladi Lepa and Phototherapy in the management of Yuvanpidaka.

 

ASSESMENT CRITERIA :

 

Ø   Performa will be developed on the basis of classical signs and symptoms of Yuvanpidaka of ayurvedic texts.

Ø   GAGS Performa

 
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