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CTRI Number  CTRI/2022/08/044644 [Registered on: 04/08/2022] Trial Registered Prospectively
Last Modified On: 03/08/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Assessment of changes in tongue flora before and after giving Ayurvedic appetizer-digestives prior to purification therapy. 
Scientific Title of Study   An observational study to assess the changes of tongue microbiota after deepana pachana prior to sodhana 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrLavanya SD 
Designation  PG Scholar 
Affiliation  Amrita Vishwa Vidyapeetham 
Address  Department of Panchakarma Amrita School of Ayurveda,Amritapuri,Amrita Vishwa Vidyapeetham Kollam, Kerala ,India
Department of Panchakarma, Amrita School of Ayurveda, Clappana PO
Kollam
KERALA
690525
India 
Phone  9496701233  
Fax    
Email  lavanyanairsd@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DrVishnu U 
Designation  Associate professor 
Affiliation  Amrita Vishwa Vidyapeetham 
Address  Department of Panchakarma Amrita School of Ayurveda,Amritapuri,Amrita Vishwa Vidyapeetham, Clappana.PO ,Kollam,Kerala ,India
Department of Panchakarma, Amrita School of Ayurveda, Amritapuri, Clappana PO
Kollam
KERALA
690525
India 
Phone  9567198958  
Fax    
Email  vishnuu@ay.amrita.edu  
 
Details of Contact Person
Public Query
 
Name  Dr Lavanya SD 
Designation  2nd Year PG Scholar 
Affiliation  Amrita Vishwa Vidyapeetham 
Address  Department of Panchakarma Amrita School of Ayurveda,Amritapuri,Amrita Vishwa Vidyapeetham, Clappana.PO ,Kollam,Kerala ,India
Department of Panchakarma,Amrita School of Ayurveda, Amritapuri, Clappana PO
Kollam
KERALA
690525
India 
Phone  9496701233  
Fax    
Email  lavanyanairsd@gmail.com  
 
Source of Monetary or Material Support  
Amrita School of Ayurveda,Amrita Vishwa Vidyapeetham,Amritapuri,Clappana P.O,Vallikkavu,Kollam,690525,Kerala,India 
 
Primary Sponsor  
Name  Dr Lavanya SD 
Address  Saranyas,Ottoor,Manambur P.O, 695611,Thiruvananthapuram, Kerala,  
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 Lavanya SD  Amrita School of Ayurveda Hospital  Department of Panchakarma Amrita School of Ayurveda, Amrita Vishwa Vidyapeetham, Amritapuri ,Clappana .P.O,690525
Kollam
KERALA 
9496701233

lavanyanairsd@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC AIMS KOCHI  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K929||Disease of digestive system, unspecified,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-pAcana, पाचन (Procedure Reference: Sharngadhara Samhita Prathama khanda 4 th Chapter 1 st sloka, Procedure details: 3 times per day)
(1) Medicine Name: Trikatu, Reference: Sushrutha Samhita, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: tds, Duration: 3 Days
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1 Sodhana arha

 
 
ExclusionCriteria 
Details  1 Sodhana anarha
2 Oral pathology
3 Having any systemic diseases .
4 Use of antibiotics,or immune suppressive medications , NSAIDS in the past 3 months
5 Smokers ,Tobacco ,Alcohol
6 Use of mouthwash
7 Over toothbrushing (more than 2)
8 Recently admitted in hospital for any health issues.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the composition and load of the tongue microbiota after Deepana pachana prior to sodhana .
 
Pre and post analysis of the composition and load of the tongue swab sample on the zeroth day and on the fourth day 
 
Secondary Outcome  
Outcome  TimePoints 
Assessment of the composition and load of the tongue microbiota used to validate Deepana pachana prior to sodhana .
 
Pre and post assessment of the tongue swab sample on the zeroth day before starting the intervention and on the fourth day after the proper attainment of deepana pachana. 
 
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   Phase 4 
Date of First Enrollment (India)   14/08/2022 
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 Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

An observational study to assess the changes of tongue microbiota after deepana pachana prior to sodhana

Rationale of the study :  Deepana pachana chikitsa  is categorized as one among the poorvakarmas. This  refers to the oral administration of certain medicines that aid the process of digestion ,thus ensuring the optimal state of koshta . Deepana pachana karmas play an important role in bringing the saama dosha to nirama dosha avastha. As a part of poorvakarma  in panchakarma , Deepana pachana is a necessary mode of treatment .Prior to snehapana proper deepana pachana is mandatory. Jihva pareeksha is one among Ashtasthana pareeksha & it  reveals a variety of clinical informations . Duration of deepana pachana is mentioned in the classics ,till obtaining  samyak langhana lakshana ie, sense of  purity of mouth, that can be taken as anulipta jihva, nirama avastha . By doing  tongue bacterial culture we can find out the bacterial load in the tongue swab sample.

 

Primary objective is to  assess the composition and load of the tongue microbiota after deepana pachana prior to sodhana .

  Secondary objective : Can assessment of tongue microbiota used to validate deepana pachana prior to sodhana  .

Methodology: 30 individuals fulfilling the inclusion criteria  will be selected from OPD & IPD of Amrita school of Ayurveda prior to sodhananga snehapana . 

Study design  and  study settings : Single group Observational study at Amrita school of Ayurveda & hospital .

Duration of the study:18 months.  

Inclusion criteria : Sodhana arha Age –20-70  years ,Irespective of Gender

Exclusion criteria : Sodhana anarha , Oral pathology , Having any systemic diseases ,Use of antibiotics or immune suppressive medications , NSAIDS in the past 3 months , Smokers , Tobacco,Alcohol, Use of mouthwash , Over toothbrushing (more than 2) , Recently admitted  in hospital for any health issues.

Procedure  : 30  individuals will be selected satisfying the inclusion criterias ,after screening the patients before starting deepana pachana ,swab from  the  coated tongue will be  collected  at the morning before toothbrushing and cultured using biochemical  method . Individuals will be given  appropriate deepana pachana aushadhi according to  the condition . The day when attaining samyak langhita lakshanas , pakvamala lakshana & Aama pachana (by observing tongue coating) stop deepana pachana ,  tongue swab will be collected & cultured . Examine plates for understanding any change in microbial load .

 Tongue swab from coated tongue will be collected before and after administration of deepana pachana . Collected swab will be cultured using biochemical  method . Examine the  plates for observing the microbial load .

 

                                      

 

 

 

 

 

 
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