| CTRI Number |
CTRI/2025/07/090956 [Registered on: 15/07/2025] Trial Registered Prospectively |
| Last Modified On: |
10/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Clinical study on the management of Eczema |
|
Scientific Title of Study
|
Evaluation of Clinical efficacy of Khadira Saaradi churna Oral And Edagajadi Lepa External in the management of Vicharchika wsr To Eczema |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Chevuri Spandana |
| Designation |
Post Graduate In Kayachikitsa |
| Affiliation |
Dr BRKR Government Ayurvedic College And Hospital |
| Address |
Dr BRKR Government Ayurvedic College And Hospital
Department of Kayachikitsa
Room no 2
Division no 2
Erragadda
Hyderabad
Telangana 500018
India
Hyderabad
TELANGANA
500018
India |
| Phone |
7702122286 |
| Fax |
|
| Email |
spandanachevuri14@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr K Aruna Gayathri |
| Designation |
Professor MD Ayurveda Department Of Kayachikitsa |
| Affiliation |
Dr BRKR Government Ayurvedic College and Hospital |
| Address |
Dr BRKR Government Ayurvedic College And Hospital
Department of kayachikitsa
Room no 2
Division 2
Erragadda
Hyderabad
Telangana 500018
India
Hyderabad
TELANGANA
500018
India |
| Phone |
9490285547 |
| Fax |
|
| Email |
ketharajugayathri@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr K Aruna Gayathri |
| Designation |
Professor MD Ayurveda Department Of Kayachikitsa |
| Affiliation |
Dr BRKR Government Ayurvedic College and Hospital |
| Address |
Dr BRKR Government Ayurvedic College And Hospital
Department of kayachikitsa
Room no 2
Division 2
Erragadda
Hyderabad
Telangana 500018
India
Hyderabad
TELANGANA
500018
India |
| Phone |
9490285547 |
| Fax |
|
| Email |
ketharajugayathri@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr BRKR Government Ayurvedic Medical College and Hospital Erragadda Hyderabad 500018 |
|
|
Primary Sponsor
|
| Name |
Dr Chevuri Spandana |
| Address |
Dr BRKR Government Ayurvedic College And Hospital Erragadda Hyderabad Telangana 500018 India |
| 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 Chevuri Spandana |
Dr BRKR Government Ayurvedic College And Hospital |
Dr BRKR Government Ayurvedic College And Hospital
Department of Kayachikitsa
room no 2 Division 2 Erragadda Hyderabad Telangana 500018 India
Hyderabad
TELANGANA |
07702122286
spandanachevuri14@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee of Dr BRKR Government Ayurvedic College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L209||Atopic dermatitis, unspecified. Ayurveda Condition: VICARCIKA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: KHADIRA SAARADI CHURNAM, Reference: Gada nigraha Kushta Adhyaya, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -Luke warm water), Additional Information: -(2) Medicine Name: EDAGAJADI LEPA, Reference: Chakradatta Kushta Adhyaya, Route: Topical, Dosage Form: Lepa Churna, Dose: 10(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients of either gender with the age group between 18 - 60 years
Classical Signs and Symptoms of Vicharchika like Kandu Pidaka Shyavavarna Rukshatha and with or without Srava
Recently diagnosed and with chronicity less than 3 years
Patients suffering with controlled Diabetes mellitus
Patients who has given consent for the study |
|
| ExclusionCriteria |
| Details |
Patients of either gender with the age group below 18 years and above 60 years
Lactating mother and pregnant women
Lesions with secondary infection
Patients suffering with Uncontrolled Diabetes mellitus Uncontrolled Hypertension Malignancies AIDS TB And Other Systemic Disorders which interferes with the course of treatment |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To reduce the Itching of Eczema |
45 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To reduce the symptoms of disease vicharchika |
45 Days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
25/07/2025 |
| 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="1"
Months="6"
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
|
Ayurveda has given prime importance to skin disorders since ancient times A Wide range of Skin Diseases are included under KUSTA Which is further classified as Mahakustas and Kshudrakustas Vicharchika is one among the Kshudra kustas which is tridoshaja vyadhis having classical signs and symptoms of KANDU because of Kapha SRAVA due to Pitta dominance and SHYAVA VARNA due to dominance of Vata As per Modern Medicine VICHARCHIKA analogous with Eczema Ayurveda describes a multitude of treatment modalities for skin diseases One of them being topical use of medicaments over the skin which allows faster absorption and better treatment of skin diseases Even though there are many medications to combat the disease vicharchika it is the quality that matters Hence the study has been initiated to findout simple economic and effective medicament for Vicharchika In the present context an attempt has been made to bring out an effective management for the disease VICHARCHIKA by using herbo-mineral compound KHADIRASAARADI CHURNA for Oral Administration is having Rasayana Tridoshahara Anulomana Mehahara properties and EDAGAJADI LEPA for external use is having Lekhana Kustagna Kandughna Rasayana properties |