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CTRI Number  CTRI/2023/03/050245 [Registered on: 02/03/2023] Trial Registered Prospectively
Last Modified On: 19/01/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A Clinical Trial to study the Safety And Efficacy of ACIDEEM Plus Tablet Vs Pantoprazole 40mg tablet for Reflux Disease, Regurgitation and Heartburn, Acidity in Indian adults for decreasing upper Gastrointestinal symptoms. 
Scientific Title of Study   Prospective, Open label, observational, Multicenter study for evaluation of efficacy and safety of ACIDEEM Plus Tablet vs Pantoprazole 40mg for Reflux disease, regurgitation and heartburn, acidity in Indian adults for decreasing upper gastrointestinal symptoms. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
HHCRS/ACIDEEMPLUS/008/20222 Version 1.0  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrAshwin Porwal 
Designation  Principal Investigator 
Affiliation  Healing hands clinic. 
Address  4th Floor, Millennium Star Extension, Landmark: Adjacent to Ruby Hall Entrance Gate, dhole patil Pune

Pune
MAHARASHTRA
411001
India 
Phone  9822347770  
Fax    
Email  drashwinporwal@healinghandsclinic.co.in  
 
Details of Contact Person
Scientific Query  
Name  DrAshwin Porwal 
Designation  Principal Investigator 
Affiliation  Healing hands clinic. 
Address  4th Floor, Millennium Star Extension, Landmark: Adjacent to Ruby Hall Entrance Gate, dhole patil Pune

Pune
MAHARASHTRA
411001
India 
Phone  9822347770  
Fax    
Email  drashwinporwal@healinghandsclinic.co.in  
 
Details of Contact Person
Public Query  
Name  DrAshwin Porwal 
Designation  Principal Investigator 
Affiliation  Healing hands clinic. 
Address  4th Floor, Millennium Star Extension, Landmark: Adjacent to Ruby Hall Entrance Gate, dhole patil Pune

Pune
MAHARASHTRA
411001
India 
Phone  9822347770  
Fax    
Email  drashwinporwal@healinghandsclinic.co.in  
 
Source of Monetary or Material Support  
Healing Hands Clinic ,Ground Floor, Millenium Star Extension Adjacent to Ruby Hall Entrance Gate, Balkrishna Sakharam Dhole Patil Rd, Pune, Maharashtra 411001 
 
Primary Sponsor  
Name  Healing Hands & Herbs Pvt Ltd 
Address  101,MangalMurti Complex, C.T.S.No.990Shukrawar Peth Tilak Rd, Pune, Maharashtra 411002 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrAshwin Porwal  Healing Hands Clinic   Ground Floor, Millenium Star Extension Adjacent to Ruby Hall Entrance Gate, Balkrishna Sakharam Dhole Patil Rd, Pune, Maharashtra 411001
Pune
MAHARASHTRA 		 9822347770

drashwinporwal@healinghandsclinic.co.in 
DrAshwin Porwal  Healing Hands Clinic   Mangalmurti Complex, 105, First floor, Near Hirabaug, Tilak Road, Pune, Maharashtra 411002
Pune
MAHARASHTRA 		 9822347770

drashwinporwal@healinghandsclinic.co.in 
DrAshwin Porwal  Healing Hands Clinic   101/102 Girme Towers, Salunke Vihar Rd, next to HDFC Bank, opp. Kotak Mahindra Bank, Oxford Village, Kedari Nagar, Wanowrie, Pune, Maharashtra 411004
Pune
MAHARASHTRA 		 9822347770

drashwinporwal@healinghandsclinic.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Healing Hands IEC  Approved 
Healing Hands IEC  Approved 
Healing Hands IEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:K219||Gastro-esophageal reflux disease without esophagitis. Ayurveda Condition: AMLAPITTAM,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator Arm (Non Ayurveda)-Pantoprazole 40 mg1 tablets before breakfast and 1 tablets before dinner with water for 2 weeks
2Intervention ArmDrugOther than Classical(1) Medicine Name: Acideem Plus, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 750(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 2 Weeks, anupAna/sahapAna: No, Additional Information: 1 tablets before breakfast and 1 tablets before dinner with water for 2 weeks
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  95.00 Year(s)
Gender  Both 
Details  1.Patients aged 18 years of age.

2.Patient with diagnosis of uncomplicated symptomatic GERD.

3.Patient/Parent/legal guardian willing to give a written informed consent/parental consent/assent form.

4.Able to/Willing to strictly adhere to investigator’s prescription.
 
 
ExclusionCriteria 
Details  1.Individuals were excluded if they had taken any medications which might interfere with the action of the study medications prior to the start of the study or during the study.

2.Patient having a clinical history or symptom profile suggestive of complicated GERD, other GI diseases (including Barrett’s oesophagus, acute peptic ulcer, or indication for Helicobacter pylori eradication therapy) or any severe diseases of other major body systems.

3.Patient having any existing conditions that might compromise their safety or participation in the study. 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Other 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Compared the change in Reflux Disease Questionnaire (RDQ) Score for GERD (Heartburn+ regurgitation)  Upto 2 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Compared the change in RDQ Scores for individual heartburn, regurgitation and acidity.  Upto 2 weeks 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   13/03/2023 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None Yet. 
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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Statistical Analysis Plan
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [drashwinporwal@healinghandsclinic.co.in].

  6. For how long will this data be available start date provided 03-02-2024 and end date provided 01-03-2026?
    Response - Immediately following publication. No end date.

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

The study is a prospective, open label, observational, multicenter, study for evaluation of efficacy and safety of ACIDEEM Plus Tablet vs Pantoprazole 40mg for Reflux disease, regurgitation and heartburn, acidity in Indian adults for decreasing upper gastrointestinal symptoms”.

Eligible patients both male, female 18 years of age with symptomatic GERD will be enrolled in the study. The decision to prescribe ACIDEEM Plus Tablet or Pantoprazole tablet will be made by the treating physician as per clinical judgement. A detailed medical history will be obtained and also physical examination will be conducted for each patient by the study investigators. Treatment duration is 02 weeks and patients will be followed-up till the end of study (week 2).

At screening (Day -1 to Day 0) the potential patients will be identified by site team and a written informed consent (for patients aged 18 years and above would be procured before any study related procedures are undertaken.)  The assessment as per schedule of assessments would be performed at screening and enrolment for determining the eligibility.

A total of 100 subjects will be enrolled in the study. 50 subjects will receive ACIDEEM Plus tablet twice daily and 50 subject will receive Pantoprazole 40mg tablet as per physician discretion. The subject would be informed to visit clinic at 1 weeks (Visit 2), and 02 weeks (Visit 3). Safety assessment will be done throughout study duration.

 

 
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