| CTRI Number |
CTRI/2022/11/047087 [Registered on: 07/11/2022] Trial Registered Prospectively |
| Last Modified On: |
01/11/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Treatment protocol in Ayurveda for TINEA |
|
Scientific Title of Study
|
"A Clinical study to evaluate the therapeutic effect of Virechanottara Edagajadi lepa in Dadrukushta with special reference to Tinea infection." |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
B Naga Srujana |
| Designation |
PG Schloar |
| Affiliation |
Dr.BRKR GOVT Ayurvedic College |
| Address |
Dr. BRKR GOVT Ayurvedic College, Room No-5, Department of Panchakarma, SR. Nagar Hyderabad 500038 TELAGANA INDIA
Hyderabad
TELANGANA
500038
India |
| Phone |
9581532526 |
| Fax |
|
| Email |
bnsrujana17@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr M Praveen Kumar |
| Designation |
Associate Professor |
| Affiliation |
Dr.BRKR GOVT Ayurvedic College |
| Address |
Room No 5 Panchakarma OP
Dr.BRKR GOVT Ayurvedic college,S.R.Nagar Hyderabad 500038 TELAGANA INDIA
Hyderabad
TELANGANA
500038
India |
| Phone |
9849271601 |
| Fax |
|
| Email |
pkmadikonda@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr B Johar |
| Designation |
HOD |
| Affiliation |
Dr.BRKR GOVT Ayurvedic College |
| Address |
Room No 5 Panchakarma OP
Dr.BRKR GOVT Ayurvedic college,S.R.Nagar Hyderabad 500038 TELAGANA INDIA
Dr.BRKR GOVT Ayurvedic college,S.R.Nagar Hyderabad 500038 TELAGANA INDIA
Hyderabad
TELANGANA
500038
India |
| Phone |
09849271601 |
| Fax |
|
| Email |
pkmadikonda@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr.BRKR GOVT Ayurvedic college,S.R.Nagar Hyderabad. |
|
|
Primary Sponsor
|
| Name |
Dr.BRKR GOVT Ayurvedic Medical college |
| Address |
Dr.BRKR GOVT Ayurvedic college,S.R.Nagar Hyderabad 500038 TELAGANA INDIA |
| 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 |
| B Naga Srujana |
Dr.BRKR GOVT Ayurvedic college |
Room No 5 Panchakarma OP
Dr.BRKR GOVT Ayurvedic college,S.R.Nagar Hyderabad 500038 TELAGANA INDIA
Hyderabad
TELANGANA |
09581532526
bnsrujana17@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:B356||Tinea cruris. Ayurveda Condition: DADRU-KUSHTHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | virechana and lepa | (Procedure Reference: chakradattta, Procedure details: 3-5 days:deepan pachan with trikatu churna orally
3-7 days: snehapana with Mahatiktaka gruta orally
3 days: abhyanga and nadi sweda
1 day: virechana with 4gms of Trivrit churna orally
7-14 days: Application of edagajadi lepa)
(1) Medicine Name: Edagajadi lepa, Reference: chakradatta, Route: Topical, Dosage Form: Lepa Churna, Dose: 35(g), Frequency: od, Duration: 14 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients who are eligible for sneha,sweda and
virechana.
2 patientswith early onset and chronic symptoms
3 patients with stoppage of allopathic and other
drugs |
|
| ExclusionCriteria |
| Details |
1 patients with systemic diseases like carcinoma,
ano rectal diseases etc.,
2 pregnancy and lactating mothers
3 patients are not eligible for sneha,swda,virechana
as per classics
4 patients with HIV and HbsAg positive |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Average change from baseline in following parameters: 1 severe itching which distubances sleep and other
activites 2 size of patch |
Assessment done on baseline visit (day 0) and after 4 weeks of treatment. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To improve the quality of life |
Assessment done on baseline and after 8 weeks of treatment |
|
|
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
11/11/2022 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Tinea is a common dermatologic condition. it is the common infection of the skin and nails that is caused by fungus. fungal infections are mostly caused by dermatophytes in the Trichophyton, Epidermophyton, and Microsporum these organisms metabolize and subsist on keratin in the skin nails and hair. the major types of tinea are TINEA CORPORIS TINEA PEDIS TINEA CRURIS TINEA UNGUIUM Infection is usually acquired by means of direct contact with the causative organism as may occur by walking, etc other predisposing factors may include DM, obesity and immunodeficiency. Acquisition of infection may occur by direct skin contact with an infected individual or by secondary spread from other sites of dermatophyte. Tinea cruris is far common in males than females . Tinea has symptoms like itchy, red, circular patch so it is also called Ringworm. In ayurvedic, it is compared to dadru kushta because it has symtoms kandu daha raga pidaka and utsanna mandala. the raga and daha are pitta dhusti and the symtoms like kandu and utsanna mandala are kapha dushti. so it is pitta kaphaja type. contemporary medicine is given as topical(anti fungal) as it is symptomatic treatment. In ayurveda, Panchakarma therapy helps in cleansing and detoxification of body. Virechana is one of the therapy which helps in detoxification of body. After Virechana, Edagajadi lepa is given topical (external application) . Lepa after Virechana works effectively as mentioned in classics. this study is designed as single arm study in patients with Virechanottara Edagajadi lepa . After sreening, patients will be enrolled if they satisfy inclusion and exclusion ceiteria. the patients will be assessed clinically on baseline,10th and 40th day of treatment. this includes as objective parameter Woodslamp examination . the total duration of treatment will be 40 days .Laboratory parameters for safety assessment will be conducted at baseline and on completion of the protocol therapy. |