| CTRI Number |
CTRI/2020/03/023910 [Registered on: 12/03/2020] Trial Registered Prospectively |
| Last Modified On: |
10/08/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A clinical study to understand the effectiveness of a new product in adult subjects with stomach problem. |
Scientific Title of Study
Modification(s)
|
A double blind, single centric, randomized, placebo-controlled study to demonstrate the efficacy and safety of RefluG (Test product) with Placebo in the management of symptoms of Gastroesophageal reflux disease (GERD). |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pendalimari Rajesh |
| Designation |
Principal Investigator |
| Affiliation |
Rajalakshmi Hospital |
| Address |
Rajalakshmi Hospital
Department of Gastroenterology
Room number-2
Ground Floor
Lakshmipura Main Road
Vidyaranyapura Post
Bangalore
KARNATAKA
560097
India |
| Phone |
|
| Fax |
|
| Email |
drrajeshrlh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepa Subramanian |
| Designation |
CEO |
| Affiliation |
Syncretic Clinical Research Services Pvt Ltd |
| Address |
Syncretic Clinical Research Services Pvt Ltd
No 32 Door No 4 (Old No.38)
5th cross 11th Main Vasanthnagar.
Bangalore
KARNATAKA
560052
India |
| Phone |
|
| Fax |
|
| Email |
deepa@syncretic.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepa Subramanian |
| Designation |
CEO |
| Affiliation |
Syncretic Clinical Research Services Pvt Ltd |
| Address |
Syncretic Clinical Research Services Pvt Ltd
No 32 Door No 4 (Old No.38)
5th cross 11th Main Vasanthnagar.
Bangalore
KARNATAKA
560052
India |
| Phone |
|
| Fax |
|
| Email |
deepa@syncretic.in |
|
|
Source of Monetary or Material Support
|
| Giellepi Spa
Via B, Cellini
37 Lissone (MB) - 20851
Italy |
|
|
Primary Sponsor
|
| Name |
Giellepi Spa |
| Address |
Via B,
Cellini 37 Lissone (MB) - 20851
Italy |
| Type of Sponsor |
Other [[Manufacturer, Limited Company] ] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Pendalimari Ramesh |
Rajalakshmi Hospital |
Department of Gastroenterology,
Ground Floor, Room No-2,
Lakshmipura Main Road
Vidyaranyapura Post
Bangalore
KARNATAKA |
9553252525
drrajeshrlh@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Rajalakshmi Hospital 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, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Fenugreek galactomannans (Trigonella foenum-graecum seed extract)
Mallow (Malva sylvestris dry extract) |
Sachet containing 10ml oral solution to be administered 3 times a day |
| Comparator Agent |
Placebo |
Sachet containing 10ml oral solution to be adminstered 3 times a day |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1 Patient should be able to give written informed consent.
2 Diagnosis of GERD by endoscopy
3 Males and females 18 -65 years of age (both inclusive).

4 Subjects who should be able to follow controlled diet (coffee and tea must be limited to not more than 2 cups per day, Chocolate, alcoholic beverages and spices should be reduced as much as possible).
5Subjects who are negative for Helicobacter pylori infection
6 Childbearing women using either oral or local contraceptives.
7 Ability to comply with requirements of trial
|
|
| ExclusionCriteria |
| Details |
Subjects with esophagitis and complications of gastroesophageal reflux disease including oesophageal stricture, Barrett’s oesophagus or adenocarcinoma of the oesophagus
Subjects with any significant intestinal maladies (including known gastric and duodenal ulcer, hiatal hernia, infections or inflammatory conditions of the small or large intestine, and obstructions)
Subjects with dyspepsia, Malabsorption, celiac disease, prior gastric surgery, pyloric stenosis, or a history of erosive esophagitis or GERD refractory to 2 months of therapy with either an H2-receptor antagonist (H2RA) or a PPI.
Known history of drug or alcohol abuse
Subjects who, in the opinion of the investigator, are mentally incapacitated such that informed consent cannot be obtained.
Subjects with clinically significant history of co-morbid condition (like, diabetes, immunodeficiency, HIV, HPV), cardiac disease, kidney disease, that in the opinion of the investigator could affect the efficacy and safety outcome of the study.
Patients suffering from any condition which in opinion of the Investigator may interfere with nutrient absorption, distribution, metabolism and excretion e.g. sub-acute obstruction, celiac disease, Crohn’s disease, Small intestine bacterial overgrowth (SIBO), chronic pancreatitis, or cystic fibrosis, lactase deficiency, or lactose intolerance, biliary atresia, parasitic diseases, diseases of the gallbladder, liver, kidney or pancreas etc.
Subject with deteriorating health status at the time of enrolment, rapid weight loss, terminal disease, significant chronic disease (e.g, chronic diarrhoea, gastro-intestinal diseases, irritable bowel syndrome)
9. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) values ≥ 2.5 X Upper Limit of Normal (ULN), Serum creatinine of ≥ 1.5 mg/dL
10. Subjects on Hormone replacement therapy or chemotherapy or radiotherapy.
Subjects participating in any other studies or participated in any clinical trial 3 months prior to start of this trial.
Pregnant women.
Known hypersensitivity to, or intolerance of, study medications or their formulation excipients.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To demonstrate that Investigational product is superior to placebo and is efficacious in symptom remission (30% more symptom remission compared to placebo) in management of GERD. |
Screening day, Day 0, 7 and 14 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1Safety will be assessed throughout by AE reporting, laboratory testing, PE, and vital signs.
2Change in symptom frequency and intensity using RDQ
3Change in GERD symptom assessed by VAS
4Change in Quality of life using GERD- HRQL- SF36
5Number of subjects with 50% reduction of symptoms compare to baseline
6Number of days required to achieve 24 hours without heartburn
7Fast action symptoms relief as mentioned in the RDQ
8Change in F.S.S.G
9Change in Heartburn Severity Index
|
Screening day, Day 0, 7 and 14 |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
Date of First Enrollment (India)
Modification(s)
|
06/06/2020 |
| Date of Study Completion (India) |
14/07/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This clinical study was planned to evaluate the safety and efficacy of a novel therapy in subjects diagnosed with Gatroesophageal reflux disease (GERD).
In this study 60 subjects will recruited who are with GERD for a treatment period of 14 days. The treatment will demonstrate that the investigational product is superior to placebo and is efficacious in symptom remission. The treatment will also evaluate for change in symptom frequency and intensity using reflux disease questionnaire, change in GERD symptoms accessed by VAS, change in QOL using HRQL-SF36, Change in frequency scale for symptom questionnaire and change in heartburn severity index from baseline to Day 7 ans 14 and also in between the groups in these visits. This study will also evaluate number of subjects with 50% reduction of symptoms compare to baseline and number of days required to achieve 24 hours without heartburn. The objective of the study is to evaluate the efficacy and safety of Reflux (IP) in subjects diagnosed with GERD when compared to placebo. Type of the study - Randomized, double blind, placebo controlled. |