| CTRI Number |
CTRI/2019/09/021362 [Registered on: 23/09/2019] Trial Registered Prospectively |
| Last Modified On: |
20/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
Public Title of Study
Modification(s)
|
Benefits and harms of using GutGard in patients suffering from heart burn / regurgitation of food known as gastro-esophageal reflux |
Scientific Title of Study
Modification(s)
|
Efficacy and safety of GutGard in the management of gastro-esophageal reflux (GER)-related symptoms - A Phase III, single centre, double-blind, parallel group, randomized placebo-controlled trial |
| Trial Acronym |
|
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nithya Gogtay |
| Designation |
Professor |
| Affiliation |
Seth GSMC & KEM Hospital |
| Address |
Department of Clinical Pharmacology
1st Floor
New Building
Seth GSMC & KEM Hospital
Parel.
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9820495836 |
| Fax |
|
| Email |
njgogtay@hotmail.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Jeffrey Pradeep raj |
| Designation |
Senior Resident |
| Affiliation |
Seth GSMC & KEM Hospital |
| Address |
Department of Clinical Pharmacology
1st Floor
New Building
Seth GSMC & KEM Hospital
Parel.
Division of Clinical Pharmacology, Sri Ramachandra Medical College, Chennai-116
Mumbai
MAHARASHTRA
400012
India |
| Phone |
07904286189 |
| Fax |
|
| Email |
jpraj.m07@gmail.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Jeffrey Pradeep raj |
| Designation |
Senior Resident |
| Affiliation |
Seth GSMC & KEM Hospital |
| Address |
Department of Clinical Pharmacology
1st Floor
New Building
Seth GSMC & KEM Hospital
Parel.
Division of Clinical Pharmacology, Sri Ramachandra Medical College, Chennai-116
Mumbai
MAHARASHTRA
400012
India |
| Phone |
07904286189 |
| Fax |
|
| Email |
jpraj.m07@gmail.com |
|
|
Source of Monetary or Material Support
|
| Natural Remedies Private Limited, Plot No. 5B, Veerasandra Indl. Area,
19th K. M. Stone,
Hosur road, Electronic City Post,
Bangalore, 560100.
Karnataka,
India. |
|
|
Primary Sponsor
|
| Name |
Natural Remedies Private Limited |
| Address |
Plot No. 5B, Veerasandra Industrial Area,19th K.M. Stone, Hosur Road, Electronic City, Bangalore, Karnataka, India – 560 100 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Jeffrey Pradeep raj |
Department of Clinical Pharmacology, 1st floor New Building |
Seth GS Medical College & KEM Hospital
Acharya Donde Marg, Parel, Mumbai - 400012
Mumbai
MAHARASHTRA |
7904286189
jpraj.m07@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Insitutional Ethics Committee I and II |
Approved |
| Insitutional Ethics Committee I and II |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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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 |
GutGard |
GutGard 75mg capsule twice daily after food intake for 4 weeks |
| Comparator Agent |
Placebo |
Matching identical placebo twice daily after food intake for 4 weeks |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Apparently healthy adults of any gender 18 - 60 years of age, willing to provide consent affected by symptoms of GER
2. History of GER-related symptoms for at least 1 month prior to study inclusion and otherwise healthy
3. Not participated in any other interventional trials in the last 1 month before trial recruitment
4. Willing to discontinue medications like H2 Receptor antagonists, Antacids, Prokinetics and supplements that have been prescribed for the GER related symptoms and not on any of these agents in the last 10 days before randomization
5. Presence of symptoms of at least 2 days in the week preceding randomization
|
|
| ExclusionCriteria |
| Details |
1. Presence of any of the following red flag symptoms of dyspepsia – Iron deficiency anaemia, dysphagia, weight loss, persistent vomiting, GI bleed, epigastric mass
2. Women of reproductive age who are pregnant / lactating / not willing for adequate contraception
3. History of allergy to any medications including alternate system of medications
4. History of uncontrolled diabetes (Random Blood Sugar > 200mg%)
5. Inability to follow-the protocol or expressed inability to complete all follow-ups
6. Abnormalities in the liver function tests (defined as total bilirubin >1mg% or SGOT / SGPT > 3 times the upper limit of normal)
7. Abnormal renal function test (Creatinine > 1.4mg%)
8. Congestive cardiac failure and other medical conditions which the investigator feels will affect the pharmacokinetic parameters of the study drug
9. History of erosive esophagitis, Barrett’s esophagus, tumoral pathologies, atypical pathology without heartburn and ulcer
10. Severe disease that affect activities of daily living as assessed by GERD – HRQoL scale, where the score for heartburn and regurgitation > 3
11. Presence of HIV, HbsAG or HCV positive and any other medical/ surgical condition the investigator feels may cause harm to the participant
|
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Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
Among patients with Gastro-esophageal Reflux (GER) related symptoms predominantly heartburn, to assess the efficacy of GutGard 150mg (75mg twice daily) in comparison to those receiving placebo over a 4-week period using
1. GERD Health-Related Quality of Life (GERD-HRQoL) on D28 .
2. Symptoms severity score as assessed by Gastroesophageal Reflux Disease Symptom Assessment Scale (GSAS) on days 7, 14, 28 and 35 |
Days 7, 14, 28 & 35 |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Frequency & level of severity of individual GER related symptoms as assessed by GSAS |
Days 7, 14, 28, 35 |
| Medication Adherence |
Days 28 |
| Number of rescue medications used |
Day 14, 28 & 35 |
| Change in Quality of life score (Global Assessment Questionnaire) |
Day 28 |
| Proportion of participants with rebound effects (requirement of at least 1 day of rescue medication or ≥ 2 days of mild symptoms) |
Day 35 |
| Change in pH at lower oesophagus and lower esophageal sphincter pressure in 10% of participants |
Anytime between days 26-28 |
| Mean percent change in gastric emptying as measured by solid meal scintigraphy |
Day 28 |
| Mean Percent Change in gastric emptying as assessed by liquid meal scintigraphy in those with abnormal solid meal scintigraphy |
Day 28 |
| Proportion of ADRs |
Days 7, 14, 21 & 28 |
|
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Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "200"
Final Enrollment numbers achieved (India)="200" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/10/2019 |
| Date of Study Completion (India) |
21/07/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not yet published anything |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
- 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.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response (Others) - Contact the corresponding author with a reasonable request
- For how long will this data be available start date provided 01-01-2022 and end date provided 01-01-2027?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
Brief Summary
Modification(s)
|
Gutgard® is a combination of natural flavonoids for gut health developed by Natural Remedies Pvt. Ltd. Gutgard® is derived from the roots of Glycyrrhiza glabra L. commonly known as licorice or Mulethi, widely used in Ayurveda from ancient period for reducing heartburn, to pacify altered pitta and to heal ulcers. Gutgard® is a standardized herbal composition containing more than 40 flavonoids as identified by LCMS and is free from glycyrrhizin. Flavonoids are a class of secondary metabolites of plants with multiple health benefits. The pharmacological actions of flavonoids viz.,antioxidant, anti-inflammatory, immunomodulatory and antimicrobial properties can be considered beneficial for gut health. Clinical, preclinical and in-vitro studies have demonstrated the benefit as well as the safety of Gutgard® in gut health. Preclinical studies demonstrated prokinetic effects and effects against constipation and anti-ulcer effects. While invitro studies demonstrated anti-inflammatory activity of Gutgard. In addition, Gutgard is clinically tested to manage the symptoms of FD (functional dyspepsia) and to reduce the gastric load of Helicobacter pylori. Gutgard® supports normal and healthy gastrointestinal tract. With respect to safety Gutgard is devoid of glycyrrhizin that is known to cause hypertension. Gutgard is tested in acute toxicity study demonstrated that it is safe upto 5g/kg rat body weight. In subchronic toxicity study conducted as per OECD guidelines for toxicity Gutgard demonstrated NOAEL of 1000 mg/kg rat body weight. The clinical studies on gutgard did not demonstrate any major treatment related adverse effects and is found to be well tolerated by humans. Pharmacological actions of Gutgard® Factors that are considered to be involved in FD and IBS (Irritable bowel syndrome) can be grouped under three broad physiological functions as below. 1) Normal bowel movement or gut motility 2) Immunity or gastroprotective function 3) Anti-microbial activity against H. pylori
Currently, we propose a phase III clinical trial among participants who have GER related symptoms (Heartburn and reflux) to see if it improves the symptoms. we also objectively measure the change in LES pH and pressure. We also look at the rate of gastric emptying
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