| 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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K219||Gastro-esophageal reflux disease without esophagitis. Ayurveda Condition: AMLAKAHÂ (KEVALAPITTA), |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other 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: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Placebo Tablets | A 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 disordersScreening
and Assigning: Day 0
Subject
Assessment: Day 1
Follow-up:
Day 2 for any adverse event |