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CTRI Number  CTRI/2017/02/007859 [Registered on: 14/02/2017] Trial Registered Retrospectively
Last Modified On: 09/02/2017
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A COMPARATIVE CLINICAL STUDY ON MUSTADI PRATISARAN AND MUSTADI KAVAL IN THE MANAGEMENT OF SHITADA(GINGIVITIS) 
Scientific Title of Study   A COMPARATIVE CLINICAL STUDY ON MUSTADI PRATISARAN AND MUSTADI KAVAL IN THE MANAGEMENT OF SHITADA(GINGIVITIS) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Hardikkumar V Parmar 
Designation  PG SCHOLAR 
Affiliation  Government Akhandanand Ayurvedic College 
Address  Block-689/6,"GH"Type,Sector-8, Gandhinagar-382008, Gujarat,India

Ahmadabad
GUJARAT
382008
India 
Phone  9429428599  
Fax    
Email  hardikparmar27@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Krishna Makadia 
Designation  M.S. AYURVEDA 
Affiliation  Government Akhandanand Ayurvedic College 
Address  READER Upgraded Department of Shalakyatantra Government Akhandanand Ayurvedic College Bhadra Ahmedabad GUJARAT 380001 Ahmadabad GUJARAT 380001 India

Ahmadabad
GUJARAT
380001
India 
Phone  9427410171  
Fax    
Email  drkrishna1111@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Krishna Makadia 
Designation  M.S. AYURVEDA 
Affiliation  Government Akhandanand Ayurvedic College 
Address  READER Upgraded Department of Shalakyatantra Government Akhandanand Ayurvedic College Bhadra Ahmedabad GUJARAT 380001 Ahmadabad GUJARAT 380001 India

Ahmadabad
GUJARAT
380001
India 
Phone  9427410171  
Fax    
Email  drkrishna1111@gmail.com  
 
Source of Monetary or Material Support  
GOVT AKHANDANAND AYURVED COLLEGE AND HOSPITAL,AHMEDABAD AND MANIBEN AYURVED HOSPITAL, AHMEDABAD 
 
Primary Sponsor  
Name  GOVT AKHANDANAND AYURVED COLLEGE AND HOSPITAL 
Address  OPD Of Shalakyatantra department Government Akhandanand Ayurvedic College Bhadra AND MANIBEN AYURVED HOSPITAL ASARVA Ahmedabad GUJARAT 380001 
Type of Sponsor  Government 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 
HARDIKKUMAR PARMAR  OPD OF SHALAKYATANTRA DEPARTMENT GOVT AKHANDANAND AYURVED COLLEGE, AHMEDABAD  Government Akhandanand Ayurvedic college and Hospital Bhadra Ahmedabad GUJARAT 380001 Ahmadabad GUJARAT
Ahmadabad
GUJARAT 		 9429428599

hardikparmar27@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICAL COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Shitada(Gingivitis),  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  MŪSTÄ€DI CHURNA PRATISÄ€RAN   Sufficient quantity of Drug & honey will be taken on the tip of cleaned finger and will be massaged gently over the Labial, Buccal, Lingual & Palatal Surface of gums. 
Comparator Agent  MÅ«stādi Kaval(Mouthwash)  Mouth to be rinsed thoroughly with 30 ml of Kaval(mouthwash) for 30 seconds, after that the solution should be expelled.  
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patients presenting with signs and symptoms of shitada(Gingivitis), described as per Ayurvedic and Modern science. 
 
ExclusionCriteria 
Details  Patients below 16 years and above 70 years.
Patients with pus discharge from gums.
Patients with Periodontal pocket.
Patients having any systemic diseases, i.e., diabetes mellitus, hypertension, hematological disorders, which causes gingivitis.
Patients using any other systemic drugs which may alter the result of the study.
Pregnant women.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Improvement in Akasmata raktstrava,Sotha,Mukha dorgandhyata  Improvement in Akasmata raktstrava,Sotha,Mukha dorgandhyata 
 
Secondary Outcome     
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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   N/A 
Date of First Enrollment (India)   06/09/2016 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   not yet published 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

This is a randomized, parallel group trial in Department of Shalakyatantra OPD at Government Akhandanand Ayurvedic College and hospital Ahmedabad,Gujarat. Dealing with the treatment of the disease Shitada(Gingivitis).

Acharya mentions that it should be treated with the drugs having properties like Shōthahara, Shōdhana, Raktasthambhana, and Krimighna etc.The drug mÅ«stādi yōg have all above properties.Therefore in the present study mÅ«stādi churna Pratisarana has been selected for clinical trials in group P. mÅ«stādi  Kaval has been selected for clinical trials in group K.

METHODS- In group P, mÅ«stādi  churna will be applied locally on gingiva for Pratisarana with honey

In group K, patient will be asked to withhold sufficient quantity of mÅ«stādi kaval in the oral cavity and will be advised to move the liquid comfortably (Kaval) in the oral cavity.

 
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