| CTRI Number |
CTRI/2025/04/084246 [Registered on: 07/04/2025] Trial Registered Prospectively |
| Last Modified On: |
05/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
To See The Effect Of Kanchani Taila Local Application In Dadru |
|
Scientific Title of Study
|
A Randomized Controlled Clinical Study Of Efficacy Of Kanchani Taila Local Application In The Management Of Dadru Kushtha With Special Reference To Tinea Corporis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Akshay Bhalchandra Salunke |
| Designation |
PG Scholar |
| Affiliation |
Government Ayurvedic College, Vazirabad, Nanded |
| Address |
Department of Kayachikitsa, Government Ayurvedic College,
vazirabad,Nanded PG hostel,Government Ayurvedic College,
vazirabad, Nanded
Nanded
MAHARASHTRA
431601
India |
| Phone |
8975897208 |
| Fax |
|
| Email |
salunkeakshay285@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Parshuram Dongare |
| Designation |
professor |
| Affiliation |
Government Ayurvedic College, Vazirabad, Nanded |
| Address |
Department of Kayachikitsa, Government Ayurvedic College,
vazirabad,Nanded PG hostel,Government Ayurvedic College,
vazirabad, Nanded
Nanded
MAHARASHTRA
431601
India |
| Phone |
9975778864 |
| Fax |
|
| Email |
dongarepd@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Parshuram Dongare |
| Designation |
professor |
| Affiliation |
Government Ayurvedic College, Vazirabad, Nanded |
| Address |
Department of Kayachikitsa, Government Ayurvedic College,
vazirabad,Nanded PG hostel,Government Ayurvedic College,
vazirabad, Nanded
Nanded
MAHARASHTRA
431601
India |
| Phone |
9975778864 |
| Fax |
|
| Email |
dongarepd@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurvedic College and Hospital,Vazirabad Nanded Dist.Nanded 431601 ,India |
|
|
Primary Sponsor
|
| Name |
Akshay Bhalchandra Salunke |
| Address |
Department of Kayachikitsa, Government Ayurvedic College,
vazirabad,Nanded PG hostel,Government Ayurvedic College,
vazirabad, Nanded |
| Type of Sponsor |
Other [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 Akshay Bhalchandra Salunke |
Government Ayurvedic College, vazirabad,Nanded |
Department of Kayachikitsa, Government Ayurvedic College,
vazirabad,Nanded
Nanded
MAHARASHTRA |
8975897208
salunkeakshay285@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee,Govt.Ayurved College and Hospital, Nanded |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L089||Local infection of the skin and subcutaneous tissue, unspecified. Ayurveda Condition: DADRU-KUSHTHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Kanchani taila, Reference: Rasratnasammuchay 20/205, Route: Topical, Dosage Form: Taila, Dose: 50(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Nimba taila , Reference: Bhavprakash nighantu guduchyadi varga 94, Route: Topical, Dosage Form: Taila, Dose: 50(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients Selection as per the Diagnostic criteria of dadru. Patients will be diagnosed on the basis of clinical features of Dadru Kushtha
Lakshana:- 1) Kandu
1) Raga
2) Udgata mandala
With or without following symptoms like Daha (Burning sensation) , Raukshya
(Dryness),Pidika (Eruptions) .Patints of age 18 to 70 year. Patients selection will be irrespective of social economic status and gender.Willing to sign the informed consent form. |
|
| ExclusionCriteria |
| Details |
Patients under long standing medication.(Steroids)( more than 21 Days Continued or
Inermediate in last 8 weeks.) |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the efficacy of kanchani taila in reducing kandu,raga,udgata mandala
Assessment criteria
1.kandu with the help of grading 0- no kandu ,1- kandu 2 to 3 times 2- recurrence more than 3 episodes/day, 3-continuous kandu
2. Number of mandala
3. Size of mandala in sq.cm |
15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Effect of kanchani taila on tinea corporis |
15 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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
18/04/2025 |
| 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="2"
Months="0"
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
|
This is Prospective, Randomized, Open Labelled, Controlled, Clinical Study of effect of kanchani taila local application in dadru kushtha for 15 days. Nimba Taila local application twice a day for 15 days will be given in control group.this study is conducted as PG course at single centre.Primary outcome to evaluate the effect of kanchani taila in dadru kushtha with special reference to tinea corporis. Outcome of the Study will be assesed on following criteria - 1) No. of Mandala ( No. of lesion) :- 2) Size of Mandala in sq. cm (Size of lesion ) :- ( if more than one manadala are present then measurement will be taken of biggest manadala.) |