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CTRI Number  CTRI/2025/02/081406 [Registered on: 27/02/2025] Trial Registered Prospectively
Last Modified On: 25/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Study Comparing Modified and Classical Samsarjana Krama in Improving Digestion After Samshodhana 
Scientific Title of Study   Non Randomised Controlled Clinical Trial Of Modified Samsarjana Krama And Classical Samsarjana Krama After Samshodhana In Improving Agni 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vd Priyanka Parmeshwar kalase 
Designation  PG Scholar MD Panchkarma 
Affiliation  MES Ayurved Mahavidyalaya 
Address  Second floor Panchakarma department PG Section MES Ayurved Mahavidyalaya Ghanekhunt Lote Khed Ratnagiri MAHARASHTRA 415722 India Ratnagiri MAHARASHTRA 415722 India

Ratnagiri
MAHARASHTRA
415722
India 
Phone  9146401907  
Fax    
Email  priyankakalase2307@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Vd Vrushali swami 
Designation  HOD and Professor MD Panchakarma 
Affiliation  MES Ayurved Mahavidyalaya 
Address  Second Floor Panchakarma Department PG Section MES Ayurveda Mahavidyalay Ghanekunth lote Khed Ratnagiri Ratnagiri MAHARASHTRA 415722 India

Ratnagiri
MAHARASHTRA
415722
India 
Phone  9422856123  
Fax    
Email  vrushaliswami2009@gmail.com  
 
Details of Contact Person
Public Query  
Name  Vd Priyanka Parmeshwar kalase 
Designation  PG Scholar MD Panchkarma 
Affiliation  MES Ayurved Mahavidyalaya 
Address  Second floor Panchakarma department PG Section MES Ayurved Mahavidyalaya Ghanekhunt Lote Khed Ratnagiri MAHARASHTRA 415722 India Ratnagiri MAHARASHTRA 415722 India

Ratnagiri
MAHARASHTRA
415722
India 
Phone  9146401907  
Fax    
Email  priyankakalase2307@gmail.com  
 
Source of Monetary or Material Support  
MES Ayurveda Mahavidyalay and Attached Parshuram Hospital and Research Center Ghanekunth Lote Khed Ratnagiri Maharashtra India 415722 
 
Primary Sponsor  
Name  Vd Priyanka Parmeshwar kalase 
Address  MES Ayurveda Mahavidyalay Ghanekunth Lote Khed Ratnagiri Maharashtra India 415722 
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 
vd Priyanka Parmeshwar Kalase  Parshuram Hospital & Research Center  Panchakarma opd no-4 Ghanekuntha lote khed Ratnagiri Ratnagiri MAHARASHTRA
Ratnagiri
MAHARASHTRA 		 9146401907

priyankakalase2307@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
MES Ayurved mahavidyalaya ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:K318||Other specified diseases of stomach and duodenum. Ayurveda Condition: AGNIVAISHAMYAM,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-saMsarjana-kramaH, संसर्जन-क्रमः (Procedure Reference: , Procedure details: Study of modified samsarjana krama Modified samsarjana krama is prepared on the basis of nutritional values without loosing authenticity of classical samsarjana krama Substitute for classical samsarjana krama 1 Peya - Peya 2 Vilepi - Tandul Mudga Khichadi(Semisolid Consistency) 3 Akruta Yush - Tandul Mudga Khichadi(Thick Consistency) 4 Kruta Yush - Moong Dal Curry & Rice Roti 5 Akruta Rasa - Tapahari 6 Kruta Rasa - Urad Dal Curry & Jawar Roti depending upon pravara, madhyam, avar shuddhi (7,5,3 days respectively) )
2Comparator ArmProcedure-saMsarjana-kramaH, संसर्जन-क्रमः (Procedure Reference: charak siddhisthan , Procedure details: classical samsarjana krama Peya , vilepi, yush & mamsarasa depending upon pravara, madhyam, avar shuddhi (7,5,3 days respectively))
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1 Age 18 to 60 years of age.
2 Both sex will be included.
3 Participants Willing to give informed consent
4 Shodhanarha indicated for shodhana
5 Patients who are non-vegetarian will be included in classical samsarjana krama 
 
ExclusionCriteria 
Details  1 Shodhananarha contraindicated to shodhana
2 Habituated to alcohol 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To study the effect Modified samsarjana krama is equally effective or more effective than classical samsarjana krama.  Samsarjana krama given as per pravara,madhyam and avar shuddhi mean (7,5,3 days respectively) and follow up will be on 15th day 
 
Secondary Outcome  
Outcome  TimePoints 
1. To provide easy to cook & modified samsarjana krama
2. Literature study of the samsarjana krama 		 Samsarjana krama given as per pravara,madhyam & avar shuddhi(7,5,3 days respectively) & follow up will be on 15th day 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   17/03/2025 
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   Title: NON RANDOMISED CONTROLLED CLINICAL TRIAL OF MODIFIED SAMSARJANA KRAMA AND CLASSICAL SAMSARJANA KRAMA AFTER 
SAMSHODHANA IN IMPROVING AGNI.






Null Hypothesis :  Modified samsarjana krama is not effective than classical samsarjana krama in improving agni.


Alternative Hypothesis H1: Classical samsarjana krama is more effective than modified samsarjana krama in improving agni.


Alternative hypothesis H2: Modified samsarjana krama is equally effective to classical samsarjana krama





Study type : Experimental study.




Study design : Non randomized control clinical trial 




Inclusion Criteria:
  1.  Age – 18 -60 years of age.
  2.  Both sex will be included.
  3.  Participants Willing to give informed consent.
  4. Shodhanarha6
  5. (indicated for shodhana).
  6.  Patients who are non-vegetarian, will be included in classical 
  7. samsarjana krama.




Exclusion Criteria :

        1.Shodhananarha(contraindicated to shodhana).
        2. Habituated to alcohol




Sample size: 60 (30 in each group)




Sampling technique: Purposive sampling method 




Group A (control group)
30 patients  
Classical Samsarjana Krama
10avar,10madhyam,10pravar Shuddhi




Group B(trial group) 
 30 patients
 Modified samsarjana Krama
10avar,10madhyam,10pravar shuddhi




Duration of treatment – 3, 5 & 7 days , as per uttama, madhyam & avara shuddhi




Patients coming to OPD and IPD of our hospital 




Result- Result will be drawn as per assessment criteria and statistical analysis.
 
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