| CTRI Number |
CTRI/2024/07/070470 [Registered on: 11/07/2024] Trial Registered Prospectively |
| Last Modified On: |
01/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Local application for Fungal infection |
|
Scientific Title of Study
|
A randomized controlled clinical trial to evaluate the effect of Arka taila in the management of Dadru kushta (Dermatophytosis) |
| 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 Nalina D S |
| Designation |
PG Scholar |
| Affiliation |
Alvas Ayurveda Medical College |
| Address |
Department of Kayachikitsa Alvas Ayurveda Medical college and Hospital, Vidyagiri, Moodubidire
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9481993578 |
| Fax |
|
| Email |
nalinadoddamanesk6@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Surekha Pai |
| Designation |
Professor |
| Affiliation |
Alvas Ayuveda Medical college |
| Address |
Department of Kayachikitsa Alvas Ayurveda Medical college and Hospital, Vidyagiri, Moodubidire
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
8921385332 |
| Fax |
|
| Email |
mdalvasayu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nalina D S |
| Designation |
PG Scholar |
| Affiliation |
Alvas Ayurveda Medical College |
| Address |
OPD of PG Department of Kayachikitsa Alvas Ayurveda Medical college and Hospital, Vidyagiri, Moodubidire
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9481993578 |
| Fax |
|
| Email |
nalinadoddamanesk6@gmail.com |
|
|
Source of Monetary or Material Support
|
| Alvas Ayurveda Medical college and Hospital, Vidyagiri Moodubidire, Dakshina Kannada district, Karnataka India - 574227 |
|
|
Primary Sponsor
|
| Name |
Dr Nalina D S |
| Address |
Alvas Ayurveda Medical college and hospital, Vidyagiri, Moodubidire, Dakshina Kannada, Karnataka 574227 |
| 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 Nalina D S |
Alvas Ayurveda Medical College and hospital |
PG Studies in the Department of Kayachikitsa, Alvas Ayurveda Medical College and Hospital, Vidyagiri, Moodubidire
Dakshina Kannada
KARNATAKA |
9481993578
nalinadoddamanesk6@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Clinical Ethics Committee Alvas Ayurveda Medical College, Vidyagiri, Moodubidire, Karnataka |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L99||Other disorders of skin and subcutaneous tissue in diseases classified elsewhere. Ayurveda Condition: DADRU-KUSHTHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Arka taila, Reference: 13. Radhakrushna parashara (1961) Sharangadhar Samhita Madhyama Khanda 9/144 ;Baidhyanath Ayurveda Bhavan Publication Varanasi , edition – 1st march – 1961, p.344 , Route: Topical, Dosage Form: Taila, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Muhurmuhu, Duration: 21 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: Chakramarda taila , Reference: NA, Route: Topical, Dosage Form: Taila, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Muhurmuhu, Duration: 21 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients who will give written consent.
2)Patients who fulfil the diagnostic criteria.
3)Patients who are suffering from infection not more than 6 months.
4)Patients suffering from Tinea corporis.
|
|
| ExclusionCriteria |
| Details |
1)Patients associated with other type of Kushta.
2)Patient taking immunosuppressive medicine
3)Patient who is on other antifungal therapy.
4)Patient with a previous allergic reaction to a specific treatment.
5)Patients who have lesions with secondary infections like eczematisation, cellulitis etc.
6)Patients with any other systemic disorder.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To check the parameters and assess the symptoms
1)itching
2)circular lesion
To assess the efficacy of drug Arka taila |
At Day 0 , Day 8, Day 15, Day 22, Day 32, Day 42 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
to check the parameters and assess the symptoms
1)Raga
2)Pidaka
3)Daha
4)Rookshata
|
42 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/09/2024 |
| Date of Study Completion (India) |
30/08/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
30/08/2025 |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="20" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website (NIL).
- For how long will this data be available start date provided 03-12-2025 and end date provided 19-12-2031?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
In Contemporary science, there are treatments for Tinea corporis like topical and systemic use of antifungal therapy. Over the past few years, antifungal resistance has emerged due to irrational use of antifungal agents in cutaneous mycoses. Studies around the world are noticing an increasing rise in resistance to common drugs used for the treatment of dermatophytic infection and have got multiple side effects. In Treatment of Dadru Kushta, various texts of Ayurveda has given wide range of Aushadha Yogas. Arka Taila is one of the unexplored Yoga for Dadru Kushta explained in Sharangadhara Samhita. The ingredients include Arka Haridra Sarshapa Taila all the three ingredients are having Kushtaghna and Kandughna property. Hence, an attempt will be done to evaluate the effect of Arka Taila in comparison with Chakramarda Taila which is taken as a standard drug in the management of Dadru Kushta.
This study is randomized, single blind, parallel group, actively controlled clinical study with comparitive standard drug Arka taila and Interventional drug chakramarda taila with dosage of quantity sufficient applied on affected area.
This study is cinducting on patients diagnosed with Dadru kusta belongs to the age of 18 years to 70 years who gives written and verbal consent for undergoing clinical study, Study will be conducting in Alva’s Ayurveda Medical College and Hospital, vidyagiri, Moodubidire.
Intervention period of the study is 42 days. Assessment will be done on 0th day, 8th day, 15th day, 22nd day, 32nd day and 42nd day.
Hypothesis H0 There is no statistical significant difference between the effect Arka Taila and Chakramarda Taila in the Management of Dadru Kushta. H1 There is a statistical significant difference between the effect of Arka Taila and Chakramarda Taila in the Management of Dadru Kushta.
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