| CTRI Number |
CTRI/2024/07/071084 [Registered on: 23/07/2024] Trial Registered Prospectively |
| Last Modified On: |
23/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
The efficacy of Truna taila and Abhyaristadi churna over Chakramarda taila and Vidangadi churna in the Dadru kustha(Tinea) |
|
Scientific Title of Study
|
A RANDOMIZED COMPARATIVE CLINICAL STUDY TO ASSESS THE EFFICACY OF TRUNA TAILA AND ABHAYARISTADI CHURNA OVER CHAKRAMARDA TAILA AND VIDANGADI CHURNA IN THE MANAGEMENT OF DADRU KUSHTA WITH SPECIAL REFERENCE TO TINEA INFECTION |
| 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 SANGALE VRUSHABH SHARAD |
| Designation |
BAMS PG Scholar |
| Affiliation |
BLDEAS AVS AYURVEDA MAHAVIDYALAYA VIJAYAPURA |
| Address |
Department of Kayachikitsa BLDEA AVS Ayurveda Mahavidyalaya, Hospital and Research centre Vjayapura 586109 Karnataka India
Bijapur
KARNATAKA
586109
India |
| Phone |
9130829763 |
| Fax |
|
| Email |
vrushabhsangale2288@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjay M Kadlimatti |
| Designation |
Principal and Professor |
| Affiliation |
BLDEAS AVS AYURVEDA MAHAVIDYALAYA VIJAYAPURA |
| Address |
Department of Kayachikitsa BLDEA AVS Ayurveda Mahavidyalaya, Hospital and Research centre Vjayapura 586109 Karnataka India
Bijapur
KARNATAKA
586109
India |
| Phone |
8970744656 |
| Fax |
|
| Email |
ayursanjay@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjay M Kadlimatti |
| Designation |
Principal and Professor |
| Affiliation |
BLDEAS AVS AYURVEDA MAHAVIDYALAYA VIJAYAPURA |
| Address |
Department of Kayachikitsa BLDEA AVS Ayurveda Mahavidyalaya, Hospital and Research centre Vjayapura 586109 Karnataka India
Bijapur
KARNATAKA
586109
India |
| Phone |
8970744656 |
| Fax |
|
| Email |
ayursanjay@gmail.com |
|
|
Source of Monetary or Material Support
|
| BLDEA,s AVS Ayurveda Mahavidyalya Hospital and Research Centre Vijayapura 586109 Karnataka India |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Other [Nil] |
|
|
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 Vrushabh Sangale |
BLDEAs AVS Ayurveda Mahavidyalya Hospital and Research Centre Vijayapura 586109 |
Department of Kayachikitsa,room no 10 ,BLDEAs AVS Ayurveda Mahavidyalya Hospital and Research Centre Vijayapura 586109 Karnataka India
Bijapur
KARNATAKA |
9130829763
vrushabhsangale2288@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Comittee, BLDEA AVS Ayurveda Mahavidyalaya, Hospital and Research centre Vjayapura 586109 Karnataka India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:B354||Tinea corporis. Ayurveda Condition: DADRU-KUSHTHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Abharistadi churna , Reference: sri chakrapani datta virchit,chakradatta,chapter 50 ,kushta chikitsa ,page no 472 ,verse no 63, Route: Oral, Dosage Form: Churna/ Powder, Dose: 10(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 6 Weeks, anupAna/sahapAna: Yes(details: sukoshna jala), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Truna taila , Reference: vangasena samhita kushta chapter -60 shloka 224, Route: Topical, Dosage Form: Taila, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 6 Weeks, anupAna/sahapAna: No, Additional Information: - | | 3 | Intervention Arm | Drug | Classical | | (1) Medicine Name: chakramarda taila , Reference: anbhoota dravya , Route: Topical, Dosage Form: Taila, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 6 Weeks, anupAna/sahapAna: No, Additional Information: - | | 4 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Vidangadi churna , Reference: sri chakrapani datta virchit,chakradatta,chapter 50 ,kushta chikitsa ,page no 472 ,verse no 65., Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 6 Weeks, anupAna/sahapAna: Yes(details: sukoshna jala ), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Subjects with the classical signs and symptoms of Dadru kushta like Kandu,Pidaka, Udgata Mandala, Rookshata
Willing to participate with informed consent |
|
| ExclusionCriteria |
| Details |
Subjects suffering from any chronic illness and other metabolic disorders.
The subjects suffering from other severe skin diseases and systemic disorders
Pregnant women and lactating mothers.
Complications of tinea infection are secondary bacterial infection ,tinea Incognito and majocchi granuloma will be excluded. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in symptoms like kandu,daha,pidika,rukshata and udgata mandala |
6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| complete Reduction in symptoms like kandu,daha,pidika,rukshata and udgata mandala |
10 weeks |
|
|
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 |
|
Date of First Enrollment (India)
|
07/08/2024 |
| 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="2"
Months="0"
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
|
This study is randomized comparative clinical study to assess the efficacy of Truna Taila and Abhayaristadi churna over Chakramarda Taila and Vidangadi Churna in the management of Dadru with special reference to Tinea Infection that will be conducted in BLDEA’s AVS Ayurveda Mahavidyalaya ,Hospital and Research centre Vijayapura-586109 Karnataka India |