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CTRI Number  CTRI/2024/10/074746 [Registered on: 04/10/2024] Trial Registered Prospectively
Last Modified On: 03/10/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Other 
Public Title of Study   To Evaluate the Efficacy and Safety of Dipya Acidity Relief Tablet in the Management of chronic gastritis  
Scientific Title of Study   To Evaluate Efficacy & safety of Dipya Acidity Relief Tablet in Management of chronic Gastritis. 
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.jai Kini 
Designation  PG Research Director 
Affiliation  Maharastra University of Health sciences, Nashik 
Address  Yerala Medical Trust’s Ayurveda Medical College & Research Centre 3rd floor Department -Rognidan Kharghar Navi Mumbai

Mumbai
MAHARASHTRA
410210
India 
Phone  9869046901  
Fax    
Email  researchdirectorymtayurved@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DrSandip Mali 
Designation  Sr.Manager - medico Marketing  
Affiliation  Charak Pharma Pvt.Ltd 
Address  Vedistry Pvt Ltd 3rd floor 21 Evergreen Industrial Estate Off E Moses Road, Mahalaxmi Mumbai

Mumbai
MAHARASHTRA
400011
India 
Phone  09702913695  
Fax    
Email  drsandeepmali@charak.com  
 
Details of Contact Person
Public Query  
Name  DrViraj Kelkar 
Designation  Assistant Profeesor  
Affiliation  Maharashtra university of health sciences , Nashik 
Address  Yerala Medical Trusts Ayurveda Medical College & Research Centre 3rd floor Deparment- Agadtantra Kharghar Navi Mumbai.

Mumbai
MAHARASHTRA
410210
India 
Phone  9860672704  
Fax    
Email  viraj30kelkar@gmail.com  
 
Source of Monetary or Material Support  
Vedistry Pvt Ltd 21, Evergreen Industrial Estate Off E Moses Road, Mahalaxmi Mumbai 400011  
 
Primary Sponsor  
Name  Vedistry Pvt Ltd 
Address  21, Evergreen Industrial Estate Off E Moses Road, Mahalaxmi Mumbai 400011  
Type of Sponsor  Pharmaceutical industry-Indian 
 
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 
DrJai Kini  Yerala Medical Trust’s Ayurveda College & Hopspital  OPD no -01 kayachikitsa Department Ground floor Institutional Area Sector 4 Kharghar Navi Mumbai
Mumbai
MAHARASHTRA 		 9869046901

researchdirectorymtayurved@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Yerala Medical Trusts Ayurveda Medical College & Trust Hospital ( PG Research Centre  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:K293||Chronic superficial gastritis. Ayurveda Condition: AMLAPITTAM,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugOther than Classical(1) Medicine Name: DIPYA ACIDITY RELEIF TABLET, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1. Male or Female Study Participants aged between 18 to 50 years, inclusive, at the time of signing the informed consent.
2. Completed the screening process within 3 days prior to randomization.
3. Study participant has understood and signed the informed consent form to participate in the study.
4. Study participant willing to be available for the entire study period and adhere to protocol requirements as evidenced by signing the informed consent document.
5. Study participants clinically diagnosed with chronic gastritis
 
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence   Other 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Reduction in heartburn/epigastric discomfort
2. Reduction in acid reflux in
3.Relief from gas and bloating.
4. Relief from Nausea & vomiting
5. Improvement in appetite

 		 Visit 0: Screening Day 0 (-3 days)
- Visit 1: Randomization in the study Day 1
- Visit 2: Day 15
- Visit 3: Day 30
- Visit 4: Day 45
- Visit 5: Day 60 (±3 days)
 
 
Secondary Outcome  
Outcome  TimePoints 
1. Changes in Laboratory Safety Parameters (CBC, LFT, KFT) from baseline to the end of the study.
2. Change in vital signs from baseline to the end of therapy.
3. Assessment of Adverse Events (AEs) & Serious Adverse Events (SAEs) in all enrolled Study administration  		 - Visit 0: Screening Day 0 (-3 days)
- Visit 1: Randomization in the study Day 1
- Visit 2: Day 15
- Visit 3: Day 30
- Visit 4: Day 45
- Visit 5: Day 60 (±3 days)
 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "35"
Final Enrollment numbers achieved (India)="35" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   15/10/2024 
Date of Study Completion (India) 10/05/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [drsandeepmali@charak.com].

  6. For how long will this data be available start date provided 25-09-2025 and end date provided 25-10-2042?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  


 Chronic gastritis   & Acid reflux, also known as gastroesophageal reflux disease (GERD), and heartburn are prevalent gastrointestinal disorders that result from damage to stomach  lining  &  the backflow of stomach acid into the oesophagus. These conditions can lead to symptoms such as burning chest pain, regurgitation, and discomfort, Bloating  significantly impacting daily activities and overall quality of life. While numerous over-the-counter (OTC) remedies, including antacids and proton pump inhibitors (PPIs), are available, many individuals still experience persistent symptoms, indicating a need for improved therapeutic options.

Recent research has highlighted the limitations of existing treatments, such as delayed onset of action, potential side effects, and inadequate symptom relief. As such, there is growing interest in developing a novel acidity relief tablet that combines effective active ingredients with a formulation aimed at rapid action and prolonged relief.

The Dipya Acidity Relief  Tablet is  100 % ayurvedic formulation  which acts through different pathways to treat  Acidity /Chronic Gastritis .The purpose of this clinical trial is to rigorously evaluate the efficacy, safety, and tolerability of the Dipya Acidity Relief tablet. Participants will be monitored for symptom relief over a specified period, and data will be collected on  primary  & secondary outcomes, including the duration of relief and any adverse effects experienced. By assessing the efficacy & safety of this , the trial aims to provide evidence that supports its potential as a preferred option for patients seeking effective and  long term  ayurvedic solution   from acid-related symptoms.

 

 
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