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Clinical Trials/CTRI/2022/08/044644
CTRI/2022/08/044644Not yet recruitingPhase 4

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

Dr Lavanya SD1 site in 1 country30 target enrollmentStarted: August 14, 2022Last updated:
Conditions

Trial Snapshot

Phase
Phase 4
Status
Not yet recruiting
Sponsor
Enrollment
30
Locations
1
Primary Endpoint
To assess the composition and load of the tongue microbiota after Deepana pachana prior to sodhana .

Study Overview

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 arhaAge –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 .

Study Design

Study Type
Interventional
Allocation
Not Applicable
Masking
Not Applicable

Eligibility Criteria

Ages
20.00 Year(s) to 70.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • •1 Sodhana arha.

Exclusion Criteria

  • •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.

Outcomes

Primary Outcomes

To assess the composition and load of the tongue microbiota after Deepana pachana prior to sodhana .

Time Frame: Pre and post analysis of the composition and load of the tongue swab sample on the zeroth day and on the fourth day

Secondary Outcomes

  • Assessment of the composition and load of the tongue microbiota used to validate Deepana pachana prior to sodhana .

Investigators

Sponsor
Dr Lavanya SD
Sponsor Class
Other [self]

Study Sites (1)

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