FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/07/071530 [Registered on: 30/07/2024] Trial Registered Prospectively
Last Modified On: 29/07/2024
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   AYURVEDIC APPROACH ON TREATMENT OF MUKHPAKA W.S.R STOMATITIS  
Scientific Title of Study   A comparative clinical trial to assess efficacy of Chushanarth Prayog of Gunjapatra Vati and Khadiradi Vati on Mukhpaka with special reference to Stomatitis  
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 Manjiry Kouskiya  
Designation  Post graduation student  
Affiliation  D. Y. Patil school of ayurveda deemed to be university 
Address  Shalakya tantra department, D. Y. Patil school of ayurveda deemed to be university, Nerul, Navi Mumbai

Thane
MAHARASHTRA
400706
India 
Phone  09623404680  
Fax    
Email  mkouskiya@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Kavita Thorat  
Designation  Associate professor, Shalakyatantra department  
Affiliation  D. Y. Patil school of ayurveda deemed to be university 
Address  D. Y. Patil school of ayurveda deemed to be university, Nerul, Navi Mumbai

Thane
MAHARASHTRA
400706
India 
Phone  9167219691  
Fax    
Email  kavita.thorat@dypatil.edu  
 
Details of Contact Person
Public Query  
Name  Dr Kavita Thorat  
Designation  Associate professor, Shalakyatantra department  
Affiliation  D. Y. Patil school of ayurveda deemed to be university 
Address  D. Y. Patil school of ayurveda deemed to be university, Nerul, Navi Mumbai

Thane
MAHARASHTRA
400706
India 
Phone  9167219691  
Fax    
Email  kavita.thorat@dypatil.edu  
 
Source of Monetary or Material Support  
D. Y. Patil school of ayurveda and ayurvedic hospital, Nerul, Navi Mumbai, Maharashtra, India 400706 
 
Primary Sponsor  
Name  D Y Patil school of ayurveda deemed to be university 
Address  D. Y. Patil school of ayurveda deemed to be university, Nerul, Navi Mumbai,Maharashtra, India 400706 
Type of Sponsor  Research institution and hospital 
 
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 
Dr Manjiry Kouskiya   D. Y. Patil school of ayurveda and ayurvedic hospital   OPD no 5,first floor, D. Y. Patil school of ayurveda and ayurvedic hospital,deemed to be university, Nerul, Navi Mumbai, Maharashtra India 400706
Thane
MAHARASHTRA 		 09623404680

mkouskiya@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee, D.Y.Patil school of ayurveda deemed to be university Nerul Navi Mumbai   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:K121||Other forms of stomatitis. Ayurveda Condition: MUKHAROGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Gunjapatra vati, Reference: Nighantu Sangrah, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: qid, Bhaishajya Kal: Pragbhakta, Duration: 10 Days, anupAna/sahapAna: No, Additional Information: -
2Comparator ArmDrugClassical(1) Medicine Name: Khadiradi vati, Reference: Yog Ratnakar, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: qid, Bhaishajya Kal: Pragbhakta, Duration: 10 Days, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1)Patients presenting with the clinical features of mukhpaka (stomatitis).
2)Patient with in the age group between 18 to 60 years.
3)Patients who are willing to undergo the respective treatment protocol.
4)Patients ready for trial and giving written consent.
5)Patients having mukhpaka less then 10 mm of size.
6)Patients having mukhpaka For a period less than 5 days
 
 
ExclusionCriteria 
Details  1)Patients who are below 18 years and above 60 years are excluded.
2)Patients not willing for clinical trial.
3)Patients having history of immunosupressive disorders.
4)Pregnant women and lactating mother.
5)Patients suffering from other systemic disease like Hypertension, Diabetes Mellitus, Tuberculosis and Asthma.
6)Associated with gastrointestinal disease or any skin diseases.
7)Patients having history of ulcers formed due to malignancy.
8)Patients having addiction or history of tobacco consumption.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Redness of ulcer
Number of ulcer in mouth Difficulty in chewing
Pain
Burning sensation
 		 10 Days 
 
Secondary Outcome  
Outcome  TimePoints 
Recurrence of symptoms
Redness of ulcer
Number of ulcer in mouth Difficulty in chewing
Pain
Burning sensation
 		 1 month 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   09/08/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  09/08/2024 
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   In this condition mukha is affected by paka process which is always associated with pitta dosha. The treatment of mukhpaka should be pittashamaka, Vedanasthapana, Vranashodhana, Vranaropana.
There are many drugs described in Ayurveda literature to cure Mukhpaka (Stomatitis) effectively. One of them is Gunjapatra which is having all these properties. 
Gunjapatra granules will be acting locally as well as internally, intake of drug will be easy and palatable. 
 
Close