| 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
|
|
|
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
|
|
|
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
|
|
|
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
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
| 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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