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CTRI Number  CTRI/2019/03/017993 [Registered on: 08/03/2019] Trial Registered Prospectively
Last Modified On: 24/05/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   amlapitta management with Abhayadi Vati 
Scientific Title of Study   Etio pathological study of Kaphaja Amlapitta and its management by Abhayadi Vati 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sandeep raman 
Designation  MD Ayurveda Scholar of Rognidana Evum Vikritivijnana 
Affiliation  Institute for post graduate Teaching and Research in Ayurveda  
Address  OPD NO 16 RNVV DEPT Institute for post graduate Teaching and Research in Ayurveda Gujarat Ayurved university Jamanagar Gujarat 361008 India
OPD NO 16 RNVV DEPT Institute for post graduate Teaching and Research in Ayurveda Gujarat Ayurved university Jamanagar Gujarat 361008 India
Jamnagar
GUJARAT
361008
India 
Phone  8058244000  
Fax  02882676856  
Email  sandeepraman3@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  PROF A B THAKAR 
Designation  PROFFESOR 
Affiliation  Institute for post graduate Teaching and Research in Ayurveda  
Address  DIRECTOR Institute for post graduate Teaching and Research in Ayurveda Gujarat Ayurved university Jamanagar Gujarat 361008 India
director Institute for post graduate Teaching and Research in Ayurveda Gujarat Ayurved university Jamanagar Gujarat 361008 India
Jamnagar
GUJARAT
361008
India 
Phone  9427776660  
Fax  02882676856  
Email  anup_thakar@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Sandeep raman 
Designation  MD Ayurveda Scholar of Rognidana Evum Vikritivijnana 
Affiliation  Institute for post graduate Teaching and Research in Ayurveda  
Address  OPD NO 16 RNVV DEPT Institute for post graduate Teaching and Research in Ayurveda Gujarat Ayurved university Jamanagar Gujarat 361008 India
P.G. Boys hostel Room No. 90, Institute for post graduate Teaching and Research in Ayurveda Gujarat Ayurved university Jamanagar Gujarat 361008 India
Jamnagar
GUJARAT
361008
India 
Phone  8058244000  
Fax  02882676856  
Email  sandeepraman3@gmail.com  
 
Source of Monetary or Material Support  
Institute for post graduate Teaching and Research in Ayurveda Gujarat Ayurved University Opp city B Division police station PN MargJamnagar 361008 Gujarat 
 
Primary Sponsor  
Name  Institute for Post graduate Teaching and Research in Ayurveda Gujarat Ayurved University 
Address  Gujarat Ayurved University Opp city B division police station PN marg Jamnagar 361008 Gujarat 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
DR D H PANDYA  Room no 515 Department of Roga Nidana Evum Vikriti Vigyan IPGT&RA GAU JAMNAGAR 361008 INDIA 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR SANDEEP RAMAN   Institute for post graduate teaching and research in ayurveda  OPD no 16 department of RNVV IPGT AND RA GAU JAMNAGAR GUJARAT
Jamnagar
GUJARAT 		 8058244000
02882676856
sandeepraman3@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE IPGT&RA JAMNAGAR  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K319||Disease of stomach and duodenum, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Abhayadi Vati  4 Tab Twice in a day foir one month 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  WILLING TO PARTICIPATE
AGE BETWEEN 18 TO 60 YEAR
PATIENTS HAVING SYMPTOMS OF KAPHAJA AMLAPITTA
 
 
ExclusionCriteria 
Details  BELOW 18 YEARS AND ABOVE 60 YEARS OF AGE
SUBJECT SUFFERING GIT DISORDERS OTHER THEN KAPHAJA AMLAPITTA
1 PEPTIC ULCER
2 DUODENAL ULCER
3 PANCREATIC AND HEPATIC DISEASE
4 INFLAMATORY BOWEL DISEASE
5 MALIGANCY OF GIT
ANY SYSTEMIC DISEASE DM UNCONTROL HTN PATIENTS TAKINGS NASIDs NOT WILLING TO PATIENTS  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
assesment will be done after one month Relief in amlapitta symptoms  Relief in amlapitta symptoms 
 
Secondary Outcome  
Outcome  TimePoints 
assess will be done after one month Relief in symptoms of kaphaja amlapitta  Relief in symptoms of kaphaja amlapitta 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   15/03/2019 
Date of Study Completion (India) 18/03/2020 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 02/03/2020 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 NOT YET PUBLISHED 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary
Modification(s)  		 EtiopathologicaL study of kaphaja amlapitta and to find out effecacy of Abhayadi vati during this trial. Patients having sign and symptoms of Kaphaja Amlapitta were registered. Total 60 patients were registered in present study. All patients completed trial. No any patient was dropped out and found The trial drug Abhaydi vati had given 4 vati (500mg) after meal with honey twice in a day.that Abhayadi Vati had given a very signinificant results in subjective parameters of Kaphaja Amlapitta patients. 
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