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CTRI Number  CTRI/2023/07/054798 [Registered on: 05/07/2023] Trial Registered Prospectively
Last Modified On: 29/06/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To compare the efficacy of amlapittaghna arka and mishreya arka in the hyperacidity 
Scientific Title of Study   An open label double arm randomized comparative clinical study to evaluate the efficacy of amlapittaghna arka and mishreya arka in the management of urdhvaga amlapitta (non ulcer dyspepsia) 
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 Nikhil Chaudhari 
Designation  PG Scholar 
Affiliation  Parul Institute of Ayurved 
Address  OPD No 116 Department of Kayachikitsa Parul Ayurved Hospital Parul University PO Limda Tal Waghodia Gujarat Vadodara GUJARAT 391760 India

Vadodara
GUJARAT
391760
India 
Phone  7588318278  
Fax    
Email  cnikhil064@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Manu R 
Designation  Professor 
Affiliation  Parul Institute of Ayurved 
Address  OPD No 116 Department of Kayachikitsa Parul Ayurved Hospital Parul University PO Limda Tal Waghodia Gujarat Vadodara GUJARAT 391760 India

Vadodara
GUJARAT
391760
India 
Phone  9481328930  
Fax    
Email  dr.manurajgopal@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Nikhil Chaudhari 
Designation  PG Scholar 
Affiliation  Parul Institute of Ayurved 
Address  OPD No 116 Department of Kayachikitsa Parul Ayurved Hospital Parul University PO Limda Tal Waghodia Gujarat Vadodara GUJARAT 391760 India

Vadodara
GUJARAT
391760
India 
Phone  7588318278  
Fax    
Email  cnikhil064@gmail.com  
 
Source of Monetary or Material Support  
OPD No 116 Department of Kayachikitsa Parul Ayurved Hospital Parul University PO Limda Tal Waghodia Gujarat Vadodara 391760 
 
Primary Sponsor  
Name  Parul Ayurved Hospital 
Address  OPD No 116 Department of Kayachikitsa Parul Ayurved Hospital Parul University PO Limda Tal Waghodia Gujarat Vadodara 391760 
Type of Sponsor  Research institution and hospital 
 
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 Nikhil Chaudhari  PARUL AYURVED HOSPITAL  OPD No 116 Department of Kayachikitsa Parul Ayurved Hospital Parul University PO Limda Tal Waghodia Gujarat Vadodara 391760
Vadodara
GUJARAT 
7588318278

cnikhil064@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Parul Institute of Ayurved Parul University  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:K30||Functional dyspepsia. Ayurveda Condition: AMLAPITTAM,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Mishreya Arka, Reference: Arka Prakash, Route: Oral, Dosage Form: Arka, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information:
2Comparator ArmDrugClassical(1) Medicine Name: Amlapittaghna Arka, Reference: Arka Prakash, Route: Oral, Dosage Form: Arka, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: Madhu), Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Patients having symptoms of Amlapitta like Avipaka,Klama,Utklesha,Tikta-amla udgara,Hridaya kanthadaha,Gaurava and Aruchi

Chronicity upto 1 year 
 
ExclusionCriteria 
Details  Patients of age below 18 years and above 50 years

Chronicity more than 1 year

Duodenal ulcer, Malignancy

Symptoms like Hematemesis and Malena

Pregnant and lactating women
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Helps in reducing hyperacidity and abdomimnal discomfort  Total 15 days of treatment will be there. During these 15 days, assessment will be done on 7th and 15th day.  
 
Secondary Outcome  
Outcome  TimePoints 
To reduce sign & symptoms of hyperacidity (non ulcer dyspepsia) as follows
1) Bothersome postprandial fullness
2) Early satiety
3) Epigastric pain
4) Epigastric burning 
Total 15 days of treatment will be there. During these 15 days, assessment will be done on 7th & 15th day. 
 
Target Sample Size   Total Sample Size="62"
Sample Size from India="62" 
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 3 
Date of First Enrollment (India)   15/07/2023 
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   AIM:
  •  To evaluate the efficacy of Amlapittaghna arka and Mishreya arka in the management of Urdhvaga Amlapitta (Non-ulcer dyspepsia) 
 OBJECTIVES :

ʉۢ To study the effect of Amlapittaghna arka and Mishreya arka in the management of Urdhvaga Amlapitta based on classical symptoms of Amlapitta

ʉۢ To study the effect of Amlapittaghna arka and Mishreya arka in the management of Urdhvaga Amlapitta based on GSRS Scale and CBC

 â€¢ To compare Amlapittaghna arka and Mishreya arka. 


 
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