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CTRI Number  CTRI/2022/03/041114 [Registered on: 15/03/2022] Trial Registered Prospectively
Last Modified On: 14/03/2022
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   Use of Triphaldi mouthwash along with Triphala churna orally on mouth ulcer 
Scientific Title of Study   A Randomised Controlled Trial Of Triphaladi Gandush With Triphala Churna Internally In Pittaj Mukhapaka With Special Reference To Aphthous Ulcer. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Megha Rajaram Kamble 
Designation  PG Scholar 
Affiliation  Government Ayurved College and Hospital, Nagpur 
Address  Shalakya tantra Department, Government Ayurved College and Hospital, Raje Raghuji Nagar,Nagpur.

Nagpur
MAHARASHTRA
440024
India 
Phone  7709208606  
Fax    
Email  kamblemegha011@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Vd Vijay G Dhakate 
Designation  Associate professor 
Affiliation  Government Ayurved College and Hospital, Nagpur. 
Address  Shalakyatantra Department, Government Ayurved College and Hospital, Raje Raghuji Nagar, Nagpur.

Nagpur
MAHARASHTRA
440024
India 
Phone  9860517302  
Fax    
Email  drvijaydhakate6@gmail.com  
 
Details of Contact Person
Public Query  
Name  Vd Vijay G Dhakate 
Designation  Associate professor 
Affiliation  Government Ayurved College and Hospital, Nagpur. 
Address  Shalakyatantra Department, Government Ayurved College and Hospital, Raje Raghuji Nagar, Nagpur.

Nagpur
MAHARASHTRA
440024
India 
Phone  9860517302  
Fax    
Email  drvijaydhakate6@gmail.com  
 
Source of Monetary or Material Support  
Government Ayurved College and Hospital Nagpur 
 
Primary Sponsor  
Name  Megha Kamble 
Address  Shalakyatantra Department Government Ayurved College and hospital Raje Raghuji Nagar Nagpur 
Type of Sponsor  Other [Self sponsored] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Megha Kamble  Government Ayurved college and Hospital  Government Ayurvedic Hospital Radhe Raghuji Nagar Nagpur
Nagpur
MAHARASHTRA 		 7709208606

kamblemegha011@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committe  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:K120||Recurrent oral aphthae. Ayurveda Condition: Pittaja Mukhapaka,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Triphaladi churna, Reference: Ashtang Hriday, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 3(g), Frequency: hs, Bhaishajya Kal: 28 Days, Duration: , anupAna/sahapAna: No, Additional Information:
2Comparator ArmProcedure-gaNDUShaH, गण्डूषः (Procedure Reference: Ashtang Hriday, Procedure details: To hold Triphaladi kwath full of mouth till watering of eyes and nose.)
(1) Medicine Name: Triphaladi kwath, Reference: Ashtang Hriday, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 30(ml), Frequency: bd, Duration: 28 Days
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Patients having signs and symptoms of Pittaj Mukhapaka
Patients in between age group 16 to 50 years patients will be selected irrespective of cast sex religion and socioeconomical status patients having Pittaj Mukhapaka limited to buccal, labial mucosa and tongue. 
 
ExclusionCriteria 
Details  Patient having local lesions of deformity like gingivitis, pyorrhea, candidial ulcer, oral thrush, herpetic ulcer, traumatic etc
Previously diagnosed tubercular, syphilitic, diabetic ulcers
Immunosuppressive disorders
Known oral, throat, tongue malignancy
Moderate to severe anaemia
OSMF 
 
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 study combine effect of Triphaladi Gandush with Triphala Churna internally on parameters of Pittaj Mukhapaka.  18 months 
 
Secondary Outcome  
Outcome  TimePoints 
To study the disease Pittaj Mukhapaka according to Ayurveda in detail.
To study Aphthous Ulcer in detail with nodern point of veiw.
To study Gandush Kalpana in detail.
To observe the adverse effect if any. 		 18 months 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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)   20/03/2022 
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   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   The study is Randomised Controlled Trial of Triphaladi Gandush with Triphala Churna internally for 28 days in Pittaj Mukhapaka with special reference to Aphthous Ulcer.This is considered as a compulsory part of PG course at single centre. The primary outcome is to study the combine effect of Triphaladi Gandush with Triphala Churna internally in Pittaj Mukhapaka. The secondary outcome is to study disease Pittaj Mukhapaka according to Ayurveda in detail. To study Aphthous Ulcer with modern point of view in detail. To study Gandush Kalpana in detail. To observe the adverse effect if any. 
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