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CTRI Number  CTRI/2023/09/057804 [Registered on: 18/09/2023] Trial Registered Prospectively
Last Modified On: 18/09/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Clinical Study Of Babool Twak Kwath Gandush And Triphala Churna With Madhu Internally For Healing Pittaj Sarvasar With Special Reference To Stomatitis 
Scientific Title of Study   Randomized Open Controlled Clinical Trial To Evaluate The Efficacy Of Babool Twak Kwath Gandush And Triphala Churna With Madhu Internally In The Management Of Pittaj Sarvasar 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 Vinit Vijay Rajapure 
Designation  Post graduate scholar 
Affiliation  Hon Shri Annasaheb Dange Ayurved Medical College And Post Graduate And Research Centre Ashta Sangli 
Address  OPD NO 5 Shalakyatantra OPD Ground Floor Dhanvantari Ayurved Hospital Ashta TAL Walwa Dist Sangli

Sangli
MAHARASHTRA
416301
India 
Phone  7776999503  
Fax    
Email  rajapurevinit99@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Jayvant Kharat  
Designation  Reader 
Affiliation  Hon Shri Annasaheb Dange Ayurved Medical College And Post Graduate And Research Centre Ashta Sangli 
Address  OPD NO 5 Shalakyatantra OPD Ground Floor Dhanvantari Ayurved Hospital Ashta TAL Walwa Dist Sangli

Sangli
MAHARASHTRA
416301
India 
Phone  9604010037  
Fax    
Email  jayvantkharat55@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Jayvant Kharat  
Designation  Reader 
Affiliation  Hon Shri Annasaheb Dange Ayurved Medical College And Post Graduate And Research Centre Ashta Sangli 
Address  OPD NO 5 Shalakyatantra OPD Ground Floor Dhanvantari Ayurved Hospital Ashta TAL Walwa Dist Sangli

Sangli
MAHARASHTRA
416301
India 
Phone  9604010037  
Fax    
Email  jayvantkharat55@gmail.com  
 
Source of Monetary or Material Support  
Hon Shri Annasaheb Dange Ayurved Medical College And Post Graduate And Research Centre Ashta Sangli 
 
Primary Sponsor  
Name  Dr Vinit Rajapure 
Address  OPD NO 5 Shalakyatantra OPD Ground Floor Dhanvantari Ayurved Hospital Ashta TAL Walwa Dist Sangli  
Type of Sponsor  Other [Self] 
 
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 Vinit Rajapure  Hon Shri Annasaheb Dange Ayurved Medical College And Post Graduate And Research Centre Ashta Sangli  OPD NO 5 Shalakyatantra OPD Ground Floor Dhanvantari Ayurved Hospital Ashta TAL Walwa Dist Sangli
Sangli
MAHARASHTRA 		 7776999503

rajapurevinit99@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Hon. Annasaheb Dange Ayurved Medical College And Pg Research Centre Institutional Ethical Comittee  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: SARVASARAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Triphala churna, Reference: Bhavprakash nighantu , Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: madhu), Additional Information: -
2Intervention ArmProcedure-gaNDUShaH, गण्डूषः (Procedure Reference: Sharangdhar khand 3 10/43, Procedure details: Mixture of BharadChurna, (coarse powder) of babooltwak will be taken 40 gm of above churnawill be mixed with 640 ml of water (i.e.,1:16 proportion). Boil the mixture till 1/8th part (i.e.,80 ml) remains. Filtration will bedone. Remaining solid part will bediscarded. For every time freshly formed Kwath will be advised to patient. Patient will be provided babooltwakchurnain 40 gmpackets. Procedure of kwath will be explained in detail. Instruction paperwill be provided along churnapac)
(1) Medicine Name: Babool twak kwath , Reference: Nighantu ratnakar , Route: Topical, Dosage Form: Kwatha/Kashaya, Dose: 100(ml), Frequency: bd, Duration: 7 Days
3Comparator ArmProcedure-gaNDUShaH, गण्डूषः (Procedure Reference: Sharangdhar khand 3 10/43, Procedure details: Mixture of BharadChurna, (coarse powder) of babooltwak will be taken 40 gm of above churnawill be mixed with 640 ml of water (i.e.,1:16 proportion). Boil the mixture till 1/8th part (i.e.,80 ml) remains. Filtration will bedone. Remaining solid part will bediscarded. For every time freshly formed Kwath will be advised to patient. Patient will be provided babooltwakchurnain 40 gmpackets. Procedure of kwath will be explained in detail. Instruction paperwill be provided along churnapac)
(1) Medicine Name: Babool twak kwath, Reference: Nighantu ratnakar, Route: Topical, Dosage Form: Kwatha/Kashaya, Dose: 100(ml), Frequency: bd, Duration: 7 Days
4Comparator ArmDrugClassical(1) Medicine Name: Haridrakhand , Reference: Bhaishajya ratnavali 55 haridrakhand 2, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: milk), Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Patient Having diagnose with Pittaj Sarvasar
Patients With Aphthous Stomatitis Minor
Patients With Traumatic Stomatitis Bacterial Stomatitis Burn Injuries Drug Allergy Stomatitis
Patients Irrespective Of Gender Religion Occupation Socio Economic Status Educational Status Marital Status Caste Will Be Selected Randomly For The Study
 
 
ExclusionCriteria 
Details  Traumatic Injury Of Mouth Jagged Teeth Dental Procedural Trauma
Patients Duration Of Course Suffering From Any Systemic Illness Which Interfere The Of Duration Course DM Asthma HIV AIDS Viral Disease
For Example Herpes Zoster Bacterial Syphilis Fungal
Cases Of Carcinoma On Treatment Of Radiotherapy And Chemotherapy
Patients With Addiction Habits Such As Chewing Tobacco Pan Masala Alcohol Consumption
Patients With Recent History Of Use Of Non Steroidal Anti Inflammatory Drugs
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
to evaluate the efficacy of Babool Twak Kwath Gandush And Triphala Churna With Madhu Internally in the management of pittaj sarvasar.  15 days 
 
Secondary Outcome  
Outcome  TimePoints 
To Compare efficacy of Babool Twak Kwath Gandush And Triphala Churna With Madhu Internally with Babool Twak Kwath Gandush And Haridrakhand internally in managment of pittaj sarvasar   15 Days 
 
Target Sample Size   Total Sample Size="84"
Sample Size from India="84" 
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)   20/10/2023 
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   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   As we see the number of patients with stomatitis increasing nowadays so this study will help the patients for better healing of stomatitis this study is a randomized open controlled trial to evaluate the efficacy of Babool Twak Kwath Gandush And Triphala Churna internally in the management of Pittaj Sarvasar with special reference to stomatitis as trial drug and Babool Twak Kwath Gandush And Haridrakhand internally as control drug trial and control drugs are used as Gandush and internal medicine used for 7 days and as per need after 7 days the patients is advised to come on 15th day for follow up 42 patients in each group will be studied study will be conducted in India outcome of the study will be assessed on better healing and deduction of signs and symptoms of Pittaj Sarvasar with special reference to stomatitis    
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