FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/10/074927 [Registered on: 08/10/2024] Trial Registered Prospectively
Last Modified On: 30/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To Compare the effect of Madhu Mishrita Jatipatradi Kwatha Gandusha and Madhu Mishrita Triphala Kwatha Gandusha In Mukhpaka (stomatitis) 
Scientific Title of Study   Comparative clinical evaluation of Madhu Mishrita Jatipatradi Kwatha Gandusha and Madhu Mishrita Triphala Kwatha Gandusha In Mukhpaka 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Swati Chauhan 
Designation  Pg Scholar 
Affiliation  Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan 
Address  OPD 3, Department of Shalakya-Tantra, Patanjali ayurved hospital,Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Phase 1, Roorkee road, Haridwar, Uttarakhand, India 249405

Hardwar
UTTARANCHAL
249405
India 
Phone  7895014089  
Fax    
Email  swatichauhan707@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Anil Verma 
Designation  HOD and Professor 
Affiliation  Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan 
Address  OPD 3, Department of Shalakya-Tantra, Patanjali ayurved hospital,Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Phase 1, Roorkee road, Haridwar, Uttarakhand, India 249405

Hardwar
UTTARANCHAL
249405
India 
Phone  9897298775  
Fax    
Email  dranilverma11@gmail.com  
 
Details of Contact Person
Public Query  
Name  Swati Chauhan 
Designation  Pg Scholar 
Affiliation  Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan 
Address  OPD 3, Department of Shalakya-Tantra, Patanjali ayurved hospital,Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Phase 1, Roorkee road, Haridwar, Uttarakhand, India 249405

Hardwar
UTTARANCHAL
249405
India 
Phone  7895014089  
Fax    
Email  swatichauhan707@gmail.com  
 
Source of Monetary or Material Support  
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan 
 
Primary Sponsor  
Name  Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan 
Address  Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Haridwar, Uttarakhand, India 249405 
Type of Sponsor  Private medical college 
 
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 
Swati Chauhan  Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan  OPD 3, Department of Shalakya-Tantra, Patanjali ayurved hospital,Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Phase 1, Roorkee road, Haridwar, Uttarakhand, India 249405
Hardwar
UTTARANCHAL 		 7895014089

swatichauhan707@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee, Patanjali Ayurved College  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: MUKHAROGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-gaNDUShaH, गण्डूषः (Procedure Reference: Chakradutta 56/33, Procedure details: Patient will be made to sit comfortably in a room devoid of heavy breeze & sunlight. Patient will be asked to hold sufficient quantity of medication(Shreshtha Matra) in the oral cavity. Patient will be instructed to hold the liquid medication in the mouth until watering starts from nose, eyes & the mouth becomes full of fluid. After the stipulated time (10 min.), patient will be instructed to spit out the medication. Same procedure will be repeated for 3 times.))
2Intervention ArmProcedure-gaNDUShaH, गण्डूषः (Procedure Reference: Chakradutta 56/29, Procedure details: Patient will be made to sit comfortably in a room devoid of heavy breeze & sunlight. Patient will be asked to hold sufficient quantity of medication(Shreshtha Matra) in the oral cavity. Patient will be instructed to hold the liquid medication in the mouth until watering starts from nose, eyes & the mouth becomes full of fluid. After the stipulated time (10 min.), patient will be instructed to spit out the medication. Same procedure will be repeated for 3 times.))
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. Patients presenting with classical signs and symptoms of Mukhapaka (Stomatitis).
2. Patients willing to participate in this trial through written consent.
3. Patients above 5 years of age from either sex.
4. Patients that are Yogya for Gandusha.  
 
ExclusionCriteria 
Details  1. Patients not willing for trial.
2. Age of patients below 5 years.
3. Patients that are Ayogya for Gandusha.
4. Congenital anomalies of mouth (Cleft lip, cleft palate, oronasal fistula).
5. Traumatic wound of mouth (Dentures, sharp edged tooth).
6. Syphilis, herpes infection.
7. Ulcers formed due to malignancy.
8. Patients suffering from any other major systemic diseases like diabetes mellitus, tuberculosis, Cancer.
9. Patients suffering from Oral leucoplakia, erythroplakia, submucous fibrosis, carcinomaof oral cavity, oral candidiasis and lichen planus. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Routine blood investigations will be carried out
for all enrolled patients- CBC, ESR, RBS.
Assessment will be done on the basis of
subjective and objective parameters.
 		 Before and after treatment 
 
Secondary Outcome  
Outcome  TimePoints 
Assessment will be done on the basis of
subjective and objective parameters. 		 Before and after treatment 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   Phase 1 
Date of First Enrollment (India)   15/10/2024 
Date of Study Completion (India) 21/09/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
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
Modification(s)  		 This study is a comparative clinical evaluation of Madhu mishrita Jatipatradi kwatha Gandusha and Madhu mishrita Triphala Kwatha Gandusha in Mukhapaka. This will be conducted on 60 randomly selected patients from OPD/IPD of Shalakya- Tantra Department of Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Haridwar. Patient will be divided into two groups- 30 patients will be adminstered with Madhu mishrita Jatipatradi kwatha Gandusha and 30 patients will be adminstered with Madhu mishrita Triphala kwatha Gandusha. First follow up will be after 15 days of treatment and second follow up will be after 15 days of first follow up. Assesment will be done on the basis of subjective and objective parameters as discussed earlier. 
Close