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CTRI Number  CTRI/2024/06/069531 [Registered on: 26/06/2024] Trial Registered Prospectively
Last Modified On: 25/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Appetizer And Digestant Activity Of Supernatant Liquid Of Puffed Rice Before Ayurvedic Purification Therapy 
Scientific Title of Study   Clinical Study To Evaluate Add On Efficacy Of Deepana And Pachana Action Of Laaja Manda Before Sodhananga Snehapana 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Neha R Patel 
Designation  Post Graduate Scholar 
Affiliation  Sri Dharmasthala Manjunatheswara College Of Ayurveda And Hospital, Hassan, Karnataka 
Address  Department Of Swasthavritta Evam Yoga, Sri Dharmasthala Manjunatheswara College Of Ayurveda And Hospital, BM Road, Tanniruhalla,Hassan-573201, Karnataka, India

Hassan
KARNATAKA
573201
India 
Phone  8722343363  
Fax    
Email  neharajesh56@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Shivakumar 
Designation  Associate Professor 
Affiliation  Sri Dharmasthala Manjunatheswara College Of Ayurveda And Hospital, Hassan, Karnataka 
Address  Department Of Swasthavritta Evam Yoga, Sri Dharmasthala Manjunatheswara College Of Ayurveda And Hospital, BM Road, Tanniruhalla,Hassan-573201, Karnataka, India

Hassan
KARNATAKA
573201
India 
Phone  9886259437  
Fax    
Email  drshiva.k@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Shivakumar 
Designation  Associate Professor 
Affiliation  Sri Dharmasthala Manjunatheswara College Of Ayurveda And Hospital, Hassan, Karnataka 
Address  Department Of Swasthavritta Evam Yoga, Sri Dharmasthala Manjunatheswara College Of Ayurveda And Hospital, BM Road, Tanniruhalla,Hassan-573201, Karnataka, India

Hassan
KARNATAKA
573201
India 
Phone  9886259437  
Fax    
Email  drshiva.k@gmail.com  
 
Source of Monetary or Material Support  
Sri Dharmasthala Manjunatheswara College Of Ayurveda And Hospital, BM Road, Tanniruhalla,Hassan-573201, Karnataka, India 
 
Primary Sponsor  
Name  Sri Dharmasthala Manjunatheswara College Of Ayurveda And Hospital 
Address  Sri Dharmasthala Manjunatheswara College Of Ayurveda And Hospital, BM Road, Tanniruhalla,Hassan-573201, Karnataka, India 
Type of Sponsor  Private 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 
Dr Neha R Patel  Sri Dharmasthala Manjunatheswara College Of Ayurveda And Hospital  Department of Swasthavritta OPD Number 09 Sri Dharmasthala Manjunatheswara College Of Ayurveda And Hospital, BM Road, Tanniruhalla,Hassan-573201, Karnataka, India
Hassan
KARNATAKA 		 8722343363

neharajesh56@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Sri Dharmasthala Manjunatheswara College Of Ayurveda And Hospital, Hassan  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. Ayurveda Condition: AMADOSHAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-dIpana and pAcana (Procedure Reference: Charaka samhita, Procedure details: administration of chitrakadi vati for deepana & pachana procedure before shodananga snehapana)
(1) Medicine Name: Chitrakadi vati, Reference: Charaka samhita, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: bd, Duration: 2 Days
2Intervention ArmProcedure-dIpana and pAcana (Procedure Reference: Sushruta Samhita, Procedure details: administration of laaja manda along with chitrakadi vati before shodananga snehapana to asses its add on effectivness of deepana & pachana action)
(1) Medicine Name: Laaja manda, Reference: Sushruta Samhita, Route: Oral, Dosage Form: Tandulodaka, Dose: 3000(ml), Frequency: sos, Duration: 2 Days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1. Subjects undergoing Snehapana before Shodana (Vamana and Virechana)
2. Subjects irrespective of gender, caste and Socio-economic status will be selected
3. Subjects who are willing to sign the informed consent form
 
 
ExclusionCriteria 
Details  1. Pregnant women and lactating mother.
2. Known case of uncontrolled hypertension.
3. Known case of speech and hearing disorder.
4. Known case of psychiatric illness.
5. Non cooperative subjects.
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1.Srothoroda- obstruction of channels
2.Balabramsha- weakness
3.Gaurava- heaviness
4.Anilamoodata- bloating
5.Alasya- laziness
6.Apakti- indigestion
7.Nishteeva- salivation
8.Malasangha- constipation
9.Aruchi- tastelessness
10.Klama- mental exhaustion
11.Abhyavarana Shakti
12.Jarana Shakti
 		 2 to 5 days
 
 
Secondary Outcome  
Outcome  TimePoints 
validated ama level assessment questionairre
validated agni assessment questionnairre 		 2 to 5 days 
 
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/ Phase 3 
Date of First Enrollment (India)   08/07/2024 
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  

As agni and ama are root cause of all the diseases, while managing the diseased condition, if agni is hampered and ama is present, it has to be treated first and should bring to normalcy. Deepana-pachana is mode of treatment for agni deepana and ama pachana. In this study deepana-pachana are considered as a puravakarma before sodhana procedure and aims to asses deepana-pachana action of pathya kalpana i.e., laaja manda before sodhananga snehapana.

STUDY GROUP - A minimum of 30 subjects will be administered with chitrakadi vati, one tablet twice daily before food. Along with-it quantity sufficient of laaja manda frequently will be given for two to five days. The data will be collected before and after the study.

CONTROL GROUP -A minimum of 30 subjects will be administered with chitrakadi vati, one tablet twice daily before food, for two to five days. The data will be collected before and after the study.

 
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