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CTRI Number  CTRI/2026/03/105575 [Registered on: 06/03/2026] Trial Registered Prospectively
Last Modified On: 26/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   A Study to Find Common Skin Germs in People with Itchy and Raised Skin Rashes. 
Scientific Title of Study   An Observational Study to Explore the Presence of Staphylococcus aureus and Streptococcus pyogenes in Patients with Shitapitta, Udarda, and Kotha 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Swetha V 
Designation  PG scholar 
Affiliation  Amrita viswavidyapeetham 
Address  Room No. 313, Prasanthi Hostel, Amrita School of Ayurveda, Kollam, Kerala.

Kollam
KERALA
690525
India 
Phone  9445581866  
Fax    
Email  vswetha511@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Durgalakshmi S 
Designation  Associate Professor 
Affiliation  Amrita viswavidyapeetham 
Address  Department of Roga Nidana, Amrita School of Ayurveda, Amrita Vishwavidyapeetham,Vallikavu, Kollam, Kerala.

Kollam
KERALA
690525
India 
Phone  9495701156  
Fax    
Email  drdurgalakshmi@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Swetha V 
Designation  PG scholar 
Affiliation  Amrita viswavidyapeetham 
Address  Room No. 313, Prasanthi Hostel, Amrita School of Ayurveda, Kollam, Kerala.

Kollam
KERALA
690525
India 
Phone  9445581866  
Fax    
Email  vswetha511@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Dr Swetha V 
Address  Department of Roga Nidana, Amrita School of Ayurveda, Amrita Vishwavidyapeetham, Amritapuri Campus, Vallikavu, Kollam, Kerala. Pincode: 690525 
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 Swetha V  Amrita School of Ayurveda and Hospital  Amrita School of Ayurveda OPD, Amrita Vishwavidyapeetham, Amritapuri campus, Vallikavu, Clappana PO.
Kollam
KERALA 
9445581866

vswetha511@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
The InstitutionalEthics Committee Amrita School of Ayurveda   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L49-L54||Urticaria and erythema. Ayurveda Condition: SITAPITTAM, (2) ICD-10 Condition:L50||Urticaria. Ayurveda Condition: UDARDAH, (3) ICD-10 Condition:L00-L99||Diseases of the skin and subcutaneous tissue. Ayurveda Condition: KOTHAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patients diagnosed with Shitapitta, Udarda, or Kotha according to diagnostic features (nidana, lakshana, dosha predominance).
2.Willingness to provide informed consent.
3.Willingness to undergo nasal or throat swab collection.
 
 
ExclusionCriteria 
Details  1.Recent antibiotic use (within 14 days prior to sampling).
2.Immunocompromised patients (HIV, ongoing chemotherapy).
3.Patients with known autoimmune disease.
4.Patients unwilling to participate. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Proportion of patients diagnosed with Shitapitta, Udarda, or Kotha who show positive nasal and/or throat swab culture for Staphylococcus aureus and/or Streptococcus pyogenes, and comparison of positivity rates between Shitapitta, Udarda and Kotha.  at baseline (after culture testing for enrolled patients) 
 
Secondary Outcome  
Outcome  TimePoints 
Association between bacterial carriage & Ayurvedic diagnostic features.  at baseline 
Clinical differences in disease expression between culture-positive & culture-negative patients.  at baseline (after culture result) 
Risk factors or demographic variables influencing bacterial carriage.  at baseline 
 
Target Sample Size   Total Sample Size="77"
Sample Size from India="77" 
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)   09/03/2026 
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="8"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

This exploratory cross-sectional observational study aims to understand whether common bacteria present in the nose or throat are found in people suffering from Shitapitta, Udarda, and Kotha. These three conditions are described in classical Ayurvedic texts as itchy, raised skin eruptions with different dosha predominance, and are clinically comparable to recurrent urticaria-like skin rashes.

Patients aged 16–60 years attending the OPD, IPD, referral clinics, and special camps of Amrita School of Ayurveda Hospital will be consecutively recruited after diagnosis by a qualified Ayurvedic physician based on classical features such as nidana, lakshana, and dosha involvement. After informed consent, participants will undergo clinical assessment and nasal and/or throat swab collection under aseptic precautions. The samples will be examined in the microbiology laboratory to identify the presence of Staphylococcus aureus and Streptococcus pyogenes. Each participant’s demographic details, clinical findings, and laboratory results will be systematically recorded using unique identification numbers.

The primary objective is to determine how many patients with each condition show bacterial carriage and to compare the frequency among Shitapitta, Udarda, and Kotha. Secondary objectives include exploring relationships between bacterial presence and Ayurvedic diagnostic features, identifying differences in clinical presentation between patients with and without bacterial carriage, and describing demographic factors associated with bacterial presence.

The study is observational and exploratory in nature, focusing on identifying patterns rather than establishing cause-and-effect relationships. Findings may help clarify whether these three conditions represent distinct clinical entities and may provide supportive evidence for integrating classical Ayurvedic concepts with contemporary microbiological understanding.


 
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