| CTRI Number |
CTRI/2025/08/093796 [Registered on: 27/08/2025] Trial Registered Prospectively |
| Last Modified On: |
27/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A survey study to find cause of infectious skin disease |
|
Scientific Title of Study
|
Etiopathological study of Kustha on the basis of Aupsargika nidana and its clinical assessment by using Woods lamp. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
MEENAKSHI SHARMA |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
Bachelor of ayurvedic medicine and surgery Doctor of medicine |
| Address |
107 ROG NIDAN EVUM VIKRITI VIGYAN Department Baba Kheta Nath Government Ayurvedic College Patikara Narnaul
Mahendragarh HARYANA 123001 India |
| Phone |
8901420896 |
| Fax |
|
| Email |
drmeenakshi858@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Deepti Parashar |
| Designation |
Professor and HOD |
| Affiliation |
Bachelor of ayurvedic medicine and surgery Doctor of medicine and Doctor of philosophy |
| Address |
101 Department of Rog nidan evum vikriti vigyan Sri Krishna Ayush University Kurukshetra
Kurukshetra HARYANA 136118 India |
| Phone |
09468319931 |
| Fax |
|
| Email |
drdeeptiamehta@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Deepti Parashar |
| Designation |
Professor and HOD |
| Affiliation |
Bachelor of ayurvedic medicine and surgery Doctor of medicine |
| Address |
Department of Rog nidan evum vikriti vigyan Sri Krishna Ayush University Kurukshetra
Kurukshetra HARYANA 136118 India |
| Phone |
09468319931 |
| Fax |
|
| Email |
drdeeptiamehta@gmail.com |
|
|
Source of Monetary or Material Support
|
| Baba Kheta Nath Government Ayurvedic College and Hospital Patikara Narnaul |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 Meenakshi Sharma |
Baba Kheta Nath Government Ayurvedic College & Hospital |
Room no 13 Kayachikitsa OPD Mahendragarh HARYANA |
09468319931
drmeenakshi858@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L089||Local infection of the skin and subcutaneous tissue, unspecified. Ayurveda Condition: Skin , (2) ICD-10 Condition:L088||Other specified local infections of the skin and subcutaneous tissue. Ayurveda Condition: Skin , |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Patients suffering from skin disease age group between 18 to 45 Yrs willing to participate in the study will be included |
|
| ExclusionCriteria |
| Details |
Patients having age less than 18 and more than 45 years; special population supregnant and lactating mothers)immune-compromised patients will be excluded from the trial |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary objective of the study is to study etiological factors of Kustha and evaluate woods lamp as diagnostic and prognostic tool |
24 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To address the potential of ayurveda for controlling skin problems by means of simple and effective public health measures. |
1.5 year |
| To address the potential of ayurveda for controlling skin problems by means of simple and effective public health measures. |
2 years |
|
|
Target Sample Size
|
Total Sample Size="670" Sample Size from India="670"
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)
|
25/09/2025 |
| 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="2" Months="0" 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
|
Skin and subcutaneous diseases such as acne, alopecia, bacterial skin infections, fungal skin diseases,purities, psoriasis, scabies, urticaria, decubitus ulcers,viral skin diseases and other skin disorders are common health problems worldwide and are the leading causes of the global disease burden. With a prevalence rate of 25%, skin conditions are currently the fourth most prevalent non-fatal disease around the globe.Skin diseases contributed 1.79% to the global burden of disease measured in disability-adjusted life years (DALYs). Skin and subcutaneous diseases can lead to profound long-term alterations even after the disease has resolved, affecting not only the physical health but also the mental health and quality of life of the patient, placing a high burden on patient’s families and national healthcare systems globally.Skin conditions are often the presenting face of more severe systemic illnesses, including HIV and neglected tropical diseases (NTD), such as elephantiasis and other lymphedema causing diseases.Ayurveda Classics describes the wide spectra of all skin disorders under Kushtha and further classified in two divisions i.e. Mahakustha and Ksudrakustha.Exploring etiological factors of Kushtha is still a challenge in modern era due to change in life style and dietary pattern. Wood’s lamp is an ultraviolet device that can be a diagnostic aid to determine the infectious skin diseases. Therefore, an attempt has been made in present study to explore the Aupsargikanidanas (contagious etiology) of kushtha as described in classics and assessment of the lesions with the help of Wood’s lamp. |