| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other 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: - | | 2 | Comparator Arm | Lifestyle | - | - | 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 | | 3 | Intervention Arm | Drug | Other 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. |