| CTRI Number |
CTRI/2025/07/090762 [Registered on: 11/07/2025] Trial Registered Prospectively |
| Last Modified On: |
09/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Virechana ] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To know the effect of virechana(purgationtherapy) in kustha (tinea corporis) |
|
Scientific Title of Study
|
A comparative clinical trial to assess the effect of virechana with trivrut lehya and trivrut churna in dadru kustha |
| 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 Dhyan Ranjan Patanaik |
| Designation |
PG Scholar |
| Affiliation |
Alvas ayurveda medical college moodbidri |
| Address |
Department of panchakarma, 3rd floor Alvas ayurveda medical college moodbidri DK Karnataka
Department of panchakarma, 3rd floor Alvas ayurveda medical college moodbidri DK Karnataka
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
7022277566 |
| Fax |
|
| Email |
dhyanranjan96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Asundi Vijayalaxmi |
| Designation |
Professor |
| Affiliation |
Alvas ayurveda medical college moodbidri |
| Address |
Department of panchakarma, 3rd floor Alvas ayurveda medical college moodbidri DK Karnataka
Department of panchakarma, 3rd floor Alvas ayurveda medical college moodbidri DK Karnataka
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9995199733 |
| Fax |
|
| Email |
drvijaya121@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Asundi Vijayalaxmi |
| Designation |
Professor |
| Affiliation |
Alvas ayurveda medical college moodbidri |
| Address |
Department of panchakarma, 3rd floor Alvas ayurveda medical college moodbidri DK Karnataka
Department of panchakarma, 3rd floor Alvas ayurveda medical college moodbidri DK Karnataka
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9995199733 |
| Fax |
|
| Email |
drvijaya121@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Council for Research in Ayurvedic Sciences (CCRAS)
61-65, opp. D’ Block, D Block, Janakpuri Institutional Area, Janakpuri, New Delhi, Delhi 110058 |
|
|
Primary Sponsor
|
| Name |
CCRAS |
| Address |
Central Council for Research in Ayurvedic Sciences (CCRAS),
Ministry of AYUSH, Govt. of India
JLNBCHA Bhawan
No.61-65, Institutional Area, Opp. D Block
Janakpuri, New Delhi-110058
Email: pgstar.ayu@ccras.nic.in |
| Type of Sponsor |
Government funding agency |
|
|
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 Dhyan Ranjan Patanaik |
Alvas Ayurveda Medical College |
Department of Panchakarma, 3rd floor Alvas Ayurveda Medical College Moodbidire DK Karnataka
Department of panchakarma, 3rd floor Alvas ayurveda medical college moodbidri DK Karnataka
Dakshina Kannada
KARNATAKA |
7022277566
dhyanranjan96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethical committee alvas ayurveda medical college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L088||Other specified local infections of the skin and subcutaneous tissue. Ayurveda Condition: DADRU-KUSHTHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Trivrut lehya, Reference: Charaka Samhita, Sutrasthana 25/40, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 24(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 1 Days, anupAna/sahapAna: Yes(details: ushna jala), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Trivrut churna, Reference: charaka samhita kalpa sthana 4/14, Route: Oral, Dosage Form: Churna/ Powder, Dose: 24(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 1 Days, anupAna/sahapAna: Yes(details: ushna jala), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients having:
Patients fulfilling diagnostic criteria.
Subjects irrespective of gender, religion & socio-economic status.
Age group of 18-60 years will be randomly included for the study.
Subjects with Madhyama kostha will be included for the study.
|
|
| ExclusionCriteria |
| Details |
Subjects who have lesions with secondary infections.
Subjects diagnosed with another systemic disorder and other medications.
Subjects with mrudu koshtha and krura kostha will be avoided in the study.
Patient indicated for rukshana before snehana will be excluded for the study.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
to assess the effect of procedure on Kandu Daha Udgata Mandala Raga Rookshata
|
0th 9th and 15th day after follow up
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to observe the improvement in pidaka and KASI score |
0th 9th and 15th day after follow up |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
21/07/2025 |
| 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 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
|
Virechana dravya possess the qualties like ushna tikhshna sukshma vyavayi vikasi having predominance of prithvi ap mahabhuta and adhobhagahara prabhava by which it produces virechana. Dadru Kustha is one among kshudra kustha and is kapha pittaja in nature which is having the symptoms similar to tinea followed by the part of the body affected. According to Ayurveda shodhana and shamana are various treatment modalities for dadru kustha. In many people it has been observed that Trivrut lehya administration causes a nauseating feeling because of taste and odour hence this study is focused to give special attention on mode of administration with help of trivrut churna instead of lehya. Particpants will be included in the study after fulfilling the diagnostic criteria and inclusion criteria with informed consent and further divided into 2 groups. Assessment will be done before and after treatment and after follow up period of 15 days.H01- There is no statistically significant effect of Trivrit Lehya in Dadru Kustha H1- There is statistically significant effect of Trivrut Lehya in Dadru Kustha. H02 - There is no statistically significant effect of Trivrit Choorna in Dadru Kustha. H2 - There is statistically significant effect of Trivrit Choorna in Dadru. H03- There is no statistically significant effect of Trivrit Choorna over Trivrit Lehya in Dadru Kustha H3- There is statistically equal effect of Trivrit Choorna and Trivrit Lehya or Trivrit Churna is significantly better than Trivrit Lehya in Dadru Kustha.
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