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CTRI Number  CTRI/2023/10/058553 [Registered on: 12/10/2023] Trial Registered Prospectively
Last Modified On: 04/12/2023
Post Graduate Thesis  No 
Type of Trial  PMS 
Type of Study   Ayurveda
Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Effectiveness and safety of Formulation HB01 for instant relief from heartburn. 
Scientific Title of Study   A double-blind randomized placebo controlled Clinical study to evaluate the effectiveness and safety of Formulation HB01 for instant relief from heartburn. 
Trial Acronym  NIL  
Secondary IDs if Any  
Secondary ID  Identifier 
MGCTS/23/118 Version 1.0 Dated 10 July 2023  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Deepak Kaushal  
Designation  Principal Investigator  
Affiliation  AR Multispecialty Hospital & Research Centre, Meerut 
Address  135, Delhi Rd, beside Ramleela ground, New Punjabi Pura, Meerut, Uttar Pradesh

Meerut
UTTAR PRADESH
250002
India 
Phone  8909369611  
Fax    
Email  deepak.kaushal.5686@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Puneet Mittal  
Designation  Clinical Research Consultant 
Affiliation  Mittal Global Clinical Trial Services  
Address  Dept of Clinical Research, First Floor, MGCTS Building, Mittal Ayurved Sansthan, Mansarovar Industrial Estate, Panchli, Meerut

Meerut
UTTAR PRADESH
250002
India 
Phone  8937015757  
Fax    
Email  puneetmittal@mgcts.org  
 
Details of Contact Person
Public Query
 
Name  Puneet Mittal  
Designation  Clinical Research Consultant 
Affiliation  Mittal Global Clinical Trial Services 
Address  Dept of Clinical Research, First Floor, MGCTS Building, Mittal Ayurved Sansthan, Mansarovar Industrial Estate, Panchli, Meerut

Meerut
UTTAR PRADESH
250002
India 
Phone  8937015757  
Fax    
Email  puneetmittal@mgcts.org  
 
Source of Monetary or Material Support  
Nutrin GmbH Schnaid 36 B, 91352 Hallerndorf, German 
 
Primary Sponsor  
Name  Nutrin GmbH 
Address  Schnaid 36 B, 91352 Hallerndorf, German 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
Not applicable   Not applicable  
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Deepak Kaushal   AR Multispecialty Hospital & Research Centre  135, Delhi Rd, beside Ramleela ground, New Punjabi Pura, Beripura, Meerut, Uttar Pradesh
Meerut
UTTAR PRADESH 
8909369611

deepak.kaushal.5686@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ARMHRC Institutional Ethics Committee  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: AMLAKAH (KEVALAPITTA),  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugOther than Classical(1) Medicine Name: HB01 Tablets, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 1 Days, anupAna/sahapAna: No, Additional Information: -
2Comparator Arm (Non Ayurveda)-Placebo TabletsA Placebo Tablet to be taken once
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Gender: Non-pregnant, non-lactating female aged between 18 to 65.
2.Subject willing to give written informed consent
3.Women of child bearing potential must have a negative urine pregnancy test.
4.Free of any Kidney and Heart disorder, which in the opinion of the investigator, will interface with the study results or increase the risk of AE.
 
 
ExclusionCriteria 
Details  1.Subjects who are pregnant, breast feeding, or planning to become pregnant during the study.
2.Have any condition that, in the opinion of the investigator, would confound the safety and efficacy assessments of the product.
3.Have participated in any interventional clinical trial in the previous 30 days.
4.Have a known sensitivity to sorbitol and any of the constituents of the test product.
5.Have a history of alcohol or illegal drug/ substance abuse or suspected alcohol or illegal drug/substance abuse in the past 2 years.
6.Patients with Cholecystectomy.
7.Subject with an elevated level of calcium.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
Change in SGA self-evaluation score
Change in RDQ score 
Time frame 0-1 day
Time frame 0-1 day 
 
Secondary Outcome  
Outcome  TimePoints 
Not applicable   Not applicable  
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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   Post Marketing Surveillance 
Date of First Enrollment (India)   21/10/2023 
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="0"
Months="1"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
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  

Heartburn is a burning pain in your chest, just behind your breastbone. The pain is often worse after eating, in the evening, or when lying down or bending over. Occasional heartburn is common and no cause for alarm. Most people can manage the discomfort of heartburn on their own with lifestyle changes and nonprescription medications. Heartburn that is more frequent or interferes with your daily routine may be a symptom of a more serious condition that requires medical care.
The majority of medical professionals concur that lower esophageal dysfunction is caused by the reflux of stomach or duodenal contents into the oesophagus. It could be regarded as a functional disorder if there isn’t a visible hiatus hernia or esophagitis. Globus has also been described as being indicative of an esophageal functioning abnormality. When unrelated to dyspepsia, this sensation of having a "lump in the throat" is thought to be caused by the upper esophageal sphincter malfunctioning.
Additionally, holding back tears is thought to be a physical example of suppressed emotion. Although a lot of money and time is spent treating the symptoms of these two esophageal disorders, little is known about their prevalence, how they relate to one another, or how they differ from other functional gastrointestinal disorders

Screening and Assigning: Day 0

Subject Assessment: Day 1

Follow-up: Day 2 for any adverse event

 
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