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CTRI Number  CTRI/2025/07/090311 [Registered on: 07/07/2025] Trial Registered Prospectively
Last Modified On: 04/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Screening
Behavioral 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A SURVEY STUDY TO FIND OUT THE ETIOLOGICAL FACTOR OF PAAMA ( ATOPIC DERMATITIS ) 
Scientific Title of Study   A SURVEY STUDY TO FIND OUT THE ETIOLOGICAL FACTOR OF PAAMA ATOPIC DERMATITIS  
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Seema Bai 
Designation  MD Scholar 
Affiliation  National Institute of Ayurveda jaipur  
Address  Room no. 152,Roga Nidana Evam Vikriti Vigyana Department, National Institute of Ayurveda, Deemed to be University, Jorawar Singh Gate ,jaipur

Jaipur
RAJASTHAN
302002
India 
Phone  08741933017  
Fax    
Email  seemu247@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. BK Sevatkar 
Designation  Professor 
Affiliation  National Institute of Ayurveda jaipur  
Address  Room no. 151,Roga Nidana Evam Vikriti Vigyana Department, National Institute of Ayurveda, Deemed to be University, Jorawar Singh Gate ,jaipur

Jaipur
RAJASTHAN
302002
India 
Phone  9352311105  
Fax    
Email  drbks6@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Seema Bai 
Designation  MD Scholar 
Affiliation  National Institute of Ayurveda jaipur  
Address  Room no. 152,Roga Nidana Evam Vikriti Vigyana Department, National Institute of Ayurveda, Deemed to be University, Jorawar Singh Gate ,jaipur

Jaipur
RAJASTHAN
302002
India 
Phone  08741933017  
Fax    
Email  seemu247@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Ayurveda,Jaipur,Rajasthan,India 302002 
 
Primary Sponsor  
Name  National Institute of Ayurveda,Jaipur 
Address  National Institute of Ayurveda ,Jaipur Rajasthan 302002  
Type of Sponsor  Government 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 Seema   National Institute of Ayurveda jaipur   Room no. 150,Roga Nidana Evam Vikriti Vigyana Department, National Institute of Ayurveda, Deemed to be University, Jorawar Singh Gate ,jaipur
Jaipur
RAJASTHAN 
08741933017

seemu247@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 
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugOther than Classical(1) Medicine Name: NIARG-CT-PTL, Reference: NA, Route: Topical, Dosage Form: Lepa Churna, Dose: 5(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: -
2Comparator ArmLifestyle--Dinacarya: Wake up in bhrammuhurat, eat laghu ahara, Ritucarya: Follow the ritucharya according to ritu , Acara Rasayana:NA, Other:NA, Pathya/Apathya:yes, Pathya:ANAR, PARVAL, AAMLKI, SUKHOSHNJAL ETC, Apathya:MACHALI, AMLA PADHARTH, NAMKIN, ETC
3Intervention ArmDrugOther than Classical(1) Medicine Name: NIARG-CT-PPL , Reference: NA, Route: Topical, Dosage Form: Lepa Churna, Dose: 5(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patient with classical sign and symptoms of Paama (atopic dermatitis) like skin lesions
having severe itching with many blisters with Shwetha, Aruna, Shyava varna.
2. Patients of either sex and age greater than 18-60 years. 
 
ExclusionCriteria 
Details  1. Individuals with a history of other dermatological conditions (e.g., psoriasis, eczema) besides
atopic dermatitis.
2. Participants who are currently undergoing treatment with systemic immunosuppressive
medications or biologic therapies for any medical condition.
3. Individuals with a history of allergic reactions or adverse events to topical medications or
skincare products.
4. Participants who are unable to provide informed consent or complete the survey due to
cognitive impairment or language barriers.
5. Subjects below the age of 18 years, unless specific pediatric criteria are included in the survey
design.
6. Respondents who fail to complete essential survey questions or provide incomplete or
inconsistent responses.
7. Individuals residing outside the predefined geographic region or population demographic
targeted by the survey.
8. Participants who do not meet the predefined inclusion criteria specified in the survey protocol.
9. Respondents who are unwilling or unable to participate in additional data collection procedures. 
 
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 
Insights into the epidemiology, triggers, and management practices of atopic dermatitis in
human subjects. 
at the end of study 
 
Secondary Outcome  
Outcome  TimePoints 
To find out causative factors of PAAMA (atopic dermatitis)  at the end of study 
 
Target Sample Size   Total Sample Size="278"
Sample Size from India="278" 
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)   22/07/2025 
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="2"
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   Introduction 
In Ayurvedic texts, mainly the skin disorders are included under the Kuhstha. Kushtha are of two types one is mahakuhstha and another one is kshudra kushtha. Paama is one among Kshudra Kustha, having pitta and kapha dosha as dominant dosha according to Acharya Charaka. Lakshana told are skin lesions having severe itching with many blisters with Shweta, Aruna, Shyava varna1’ 2. Atopic dermatitis, also known as atopic dermatitis, is a chronic inflammatory skin disorder affecting millions worldwide3. Atopic dermatitis (AD) is an atopic dermatitistous eruption that is itchy, recurrent, and sym- metric. It generally begins early in life (3 months of age or so), follows periods of remissions and exacerbation, and usually resolves by the age of 15 years. Elevated IgE levels are the most consistent immune defect4. Despite various treatment options, there’s a persistent need for novel therapies. Paama, a traditional medicinal remedy, has shown promise in anecdotal evidence. 1-Chloro-2,4-dinitrobenzene (DNCB) is a chemical substance that causes chronic contact dermatitis and is widely used in human studies of AD. In this study, BALB/c mice with DNCB-induced AD are used. When DNCB is topically applied to mice, it causes dermatopathy similar to symptoms of AD, such as an increased IgE expression, inflammatory cytokines, edema and itching5. To relieve itching, medicines in the form of local application as lepa is more suitable. NIARG-CT-PPL is having shatadhouta ghrita as its base and NIARG-CT-PTL is having Sarshapa taila as base which will decrease the dryness, itching. This study aims to scientifically validate the therapeutic potential of paama in managing atopic dermatitis.

HYPOTHESIS
 Null Hypothesis:There is no association of Etiopathological factors with Paama (atopic dermatitis].
 Alternative Hypothesis (H1) – There is association of Etiopathological factors with Paama (atopic dermatitis).
 AIM :- To elucidate the etiopathological factors of paama (Atopic dermatitis) through survey analysis.
 OBJECTIVES :- To conduct a survey analysis to gather insights into the etiology, prevalence, and management practices of atopic dermatitis in human subjects.
 
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