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CTRI Number  CTRI/2024/04/065887 [Registered on: 18/04/2024] Trial Registered Prospectively
Last Modified On: 09/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   A Clinical Trial On Hyperacidity With Patolnimabadi Kashaya. 
Scientific Title of Study   Open Label Single Arm Clinical Study To Evaluate the Effect Of Patolanimbadi Kashaya in Amlapitta. 
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 Naiya Patel 
Designation  Kayachikitsa Post Graduate Scholar 
Affiliation  G.J patel Institute of Ayurvedic Studies and Research,new vallabh vidhyanagar 
Address  Department of Kayachikitsa,G.J Patel Institute Of Ayurvedic Studies And Research,S.G.Patel Ayurveda Hospital And Maternity Home,New V.V Nagar, Anand Gujarat 388121 India

Anand
GUJARAT
388121
India 
Phone  7016669241  
Fax    
Email  naiya.patel@ayugjac.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Soumya EA 
Designation  Assistant professor 
Affiliation  G.J Patel Institute of Ayurvedic Studies and Research,new vallabh vidhyanagar ,Anand 
Address  Department of Kayachikitsa,G.J Patel Institute Of Ayurvedic Studies And Research,S.G.Patel Ayurveda Hospital And Maternity Home,New V.V Nagar, Anand Gujarat 388121 India

Anand
GUJARAT
388121
India 
Phone  9847003989  
Fax    
Email  soumya.ea@cvmu.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Naiya Patel 
Designation  Kayachikitsa post graduate Scholar 
Affiliation  G.J Patel Institute of Ayurvedic Studies and Research,New Vallabh Vidhyanagar ,Anand 
Address  Department of Kayachikitsa,G.J Patel Institute Of Ayurvedic Studies And Research,S.G.Patel Ayurveda Hospital And Maternity Home,New V.V Nagar, Anand Gujarat 388121 India

Anand
GUJARAT
388121
India 
Phone  7016669241  
Fax    
Email  naiya.patel@ayugjac.edu.in  
 
Source of Monetary or Material Support  
G J Patel Institute Of Ayurvedic Studies and Research,Department of Kayachikitsa,New VallabhVidyanagar,Anand-388121 
 
Primary Sponsor  
Name  Dr Naiyaben Ashishkumar Patel 
Address  G J Patel Institute Of Ayurvedic Studies and Research,Department of Kayachikitsa,New Vallabh Vidyanagar,Anand-388121  
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 
Dr Naiya Patel  G.J Patel Institute Of Ayurvedic Studies And Research,S.G.Patel Ayurveda Hospital And Maternity Home  Department of Kayachikitsa,G.J Patel Institute Of Ayurvedic Studies And Research,S.G.Patel Ayurveda Hospital And Maternity Home, New V.V Nagar, Anand,Gujarat-388121,Anand GUJARAT
Anand
GUJARAT 		 7016669241

naiya.patel@ayugjac.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
G.J Patel Institute Of Ayurvedic Studies And Research & S.G. Patel Ayurveda Hospital & Maternity Home Institutional Ethics Committee  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: AMLAPITTAM,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Patolnimbadi Kwath, Reference: Sahasrayogam, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 48(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: Nil
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Subjects having classical symptoms of Amlapitta Such As Avipaka ,Klama, Utklesh,Tikta-amlauadgar
Hridakanthadaha, Aruchi, Gaurava.
2.Controlled cases of hypertension and diabetes mallitus
3.Chronicity not more than 1 year. 
 
ExclusionCriteria 
Details  1.Chronicity more than 1 year.
2.Known case of peptic ulcer,duodenal ulcer and Malignancy.
3.Symptoms like hematemesis and Malena.
Pregnant and Lactating women. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To improve the quality of life in amlapitta patient.  One month 
 
Secondary Outcome  
Outcome  TimePoints 
To Reduce the Severity Of Amlapitta.  0th Day first Assessment
15th Day second Assessment
30th Day third Assessment
45th Day Final Follw up 
 
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 2/ Phase 3 
Date of First Enrollment (India)   15/05/2024 
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 Yet Recruiting 
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   This is Open Label Single Arm Clinical Trial.In this Study Subjects Fullfiling the Criteria of Inclusion and Exclusion Will be Selected For the Study.Sample size is 30 and kwath will be given for 30 days.Subjects Will  be given Patolnimbadi kwath  48 ml 2 times before food.Assessment will be on 1st day.15th day,30th day and final follow up on 45th day.The Result will be analysed after appropriate statistical test. 
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