| CTRI Number |
CTRI/2024/03/064687 [Registered on: 22/03/2024] Trial Registered Prospectively |
| Last Modified On: |
06/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Tiladi Churna (orally) with Vidangadi Lepa in the Management of Dadru Kushtha(Fungal Infection) |
|
Scientific Title of Study
|
Efficacy of Tiladi Churna (orally) with Vidangadi Lepa in the Management of Dadru Kushtha- a Open Label Randomised Standard Control Study |
| 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 Tadhani Piyush Lakhmanbhai |
| Designation |
MD Scholar, Department of Roga Nidana Evum Vikriti Vigyana |
| Affiliation |
All India Institute Of Ayurveda |
| Address |
Department of Roga Nidana Evum Vikriti Vigyana, 3rd floor, Academic block, Block C, All India Institute Of Ayurveda, Gautampuri, Sarita vihar, Mathura road, New Delhi
New Delhi
DELHI
110076
India |
| Phone |
9998828083 |
| Fax |
|
| Email |
piyushtadhani555@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Anand B More |
| Designation |
Professor and Head Of Department |
| Affiliation |
All India Institute Of Ayurveda |
| Address |
Department of Roga Nidana Evum Vikriti Vigyana, 3rd floor, Academic block, Block C, All India Institute Of Ayurveda, Gautampuri, Sarita vihar, Mathura road, New Delhi
New Delhi
DELHI
110076
India |
| Phone |
9422025732 |
| Fax |
|
| Email |
drmoreanand@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Tadhani Piyush Lakhmanbhai |
| Designation |
MD Scholar, Department of Roga Nidana Evum Vikriti Vigyana |
| Affiliation |
All India Institute Of Ayurveda |
| Address |
Department of Roga Nidana Evum Vikriti Vigyana, 3rd floor, Academic block, Block C, All India Institute Of Ayurveda, Gautampuri, Sarita vihar, Mathura road, New Delhi
New Delhi
DELHI
110076
India |
| Phone |
9998828083 |
| Fax |
|
| Email |
piyushtadhani555@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute Of Ayurveda |
|
|
Primary Sponsor
|
| Name |
All India Institute Of Ayurveda |
| Address |
All India Institute Of Ayurveda, Gautampuri, Sarita Vihar, Mathura road, New Delhi 110076 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Tadhani Piyush Lakhmanbhai |
All India Institute Of Ayurveda |
Department of Roga Nidana Evum Vikriti Vigyan, OPD no. 8, Ground Floor, Hospital block, All India Institute Of Ayurveda, Gautampuri, Sarita Vihar, Mathura Road, New Delhi 110076
New Delhi
DELHI |
9998828083
piyushtadhani555@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,All India Institute of Ayurveda,New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:B359||Dermatophytosis, unspecified. Ayurveda Condition: DADRU-KUSHTHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | lepa, लेप | (Procedure Reference: Yogaratnakar, Procedure details: Two times in a day
Procedure –
•Clean the affected area with cotton soaked in water.
•Apply sufficient amount of Lepa.
•After 2 hours, the Lepa will be cleaned with water with the help of cotton swab.
)
(1) Medicine Name: Tiladi churna, Reference: Chakradatta, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: od, Duration: 30 Days | | 2 | Comparator Arm (Non Ayurveda) | | - | Terbinafine ointment | •Terbinafine ointment 1% w/w will be used for the study.
Two times in a day
Procedure -
•Clean and dry the affected skin properly.
•Then, apply a thin layer of Terbinafine ointment on and around the affected skin gently.
•Do not cover the area after applying the cream.
•Avoid getting the medicine into the eyes, nose or mouth.
|
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient with classical sign and symptoms of Dadru Kushtha
Patients willing to participate. |
|
| ExclusionCriteria |
| Details |
Patients suffering from Systemic Disorders, uncontrolled DM, HIV, Hepatitis- B, malignancy.
Cases of Burn.
Known cases of any other skin disease.
Any allergic condition related to skin and hypersensitivity to any medicine.
Pregnant and lactating women
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Resolution in the sign and symptoms of Dadru kushtha |
Assessment of sign and symptoms of dadru kushtha at baseline,30th day,60th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
•To observe & determine the growth of fungus in Dadru kushtha by culture study.
•To observe the Antifungal effect of Vidangadi lepa through sensitivity
|
1.Identification of fungus by microscopic examination using KOH(potassium hydroxide)10% at baseline
2.Assessment of Antifungal effect of Vidangadi lepa through sensitivity at baseline
|
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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)
|
15/04/2024 |
| 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
|
There
are eighteen types of Kushtha Roga
which are classified into Maha Kushtha
and Kshudra Kushtha. Dadru is
classified as a Kshudra Kushtha by ’Acharya Charaka’ and MahaKushtha by ’Acharya
Sushruta’. Mithya Ahara Vihar is the main cause of Kushtha Roga. AIM:
a) To compare the efficacy of Tiladi churna (orally) with Vidangadi Lepa (L/A) and Tiladi
churna (orally) with Terbinafine Ointment (L/A) in management of Dadru Kushtha .
b) To determine Anti-fungal effect of Vidangadi lepa in Dadru Kustha through Sensitivity.
OBJECTIVES:
PRIMARY:
•
To
compare the efficacy of Vidangadi lepa
and Terbinafine Ointment externally with Tiladi
churna internally in both group in the management of Dadru Kushtha.
SECONDARY:
•
To
observe and determine the growth of fungus in Dadru kushtha by culture study.
•
To
observe the Antifungal effect of Vidangadi
lepa through sensitivity.
|