| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K929||Disease of digestive system, unspecified, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | 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 . |