A Randomized, Double-Blind, Placebo-Controlled Trial By Herbal Creations to Evaluate the Safety and Efficacy of GUT RESET Capsules in Alleviating the Gastro-Esophageal Reflux (GER)- Related Symptoms
EFFICACY AND SAFETY VARIABLES
| Efficacy |
• Gastroesophageal Symptom Assessment Scale (GSAS) - Day 1, Day 15, Day 30, Day 45, Day 60 • Presence or Absence of Clinical Symptoms • 7 Point Likert scale - Dyspepsia Symptoms |
|---|---|
| Safety |
• Laboratory Parameters - LFT, RFT, CBC • Adverse events |
RESEARCH DESIGN AND METHODOLOGY
| Study Design | A double blinded, randomized placebo-controlled Clinical Study |
|---|---|
| Clinical Condition |
1. Gastroesophageal Reflux symptoms (Heartburn, Regurgitation, Upper abdominal or
chest pain, Trouble swallowing, sensation of lump, ongoing cough, inflammation of vocal
cords, new or worsening asthma)
2. Dyspepsia or indigestion |
| Participants | 50 subjects aged 18- 60 years (25 subjects- GUT RESET; 25 subjects- PLACEBO) |
| Study Duration | 60 days |
| Evaluation | On Day 15, 30, 45 and Day 60 |
| Study Outcomes |
• Efficacy of GUT RESET Capsules in reducing GER symptoms.
• Efficacy of GUT RESET Capsules in reducing the Dyspepsia symptoms. • Safety and tolerability of GUT RESET Capsules • To assess the quality of life |
INTRODUCTION
Rationale: Glabridin, commonly called as Liquorice demonstrated Anti-ulcer and Anti-inflammatory activity which is helpful in restoring the normal physiological activity of stomach and reduce the symptoms related to GER. as the performed study by Herbal Creations
INVESTIGATIONAL PRODUCT AND DOSE
| Dose | GUT RESET Capsule (400mg), once daily |
|---|---|
| Route of Administration | Oral |
- Each patient followed a specific dosing schedule: one 400 mg GUT RESET capsule was ingested daily in the morning after food for 60 days.
Efficacy and Safety Variables
Assessment of Severity of Gastroesophageal Symptom Assessment Scale (GSAS) from Baseline to End of Study
| Symptom | Group 1 GUT RESET |
Group 2- PLACEBO |
P value | Group 1 GUT RESET |
Group 2 PLACEBO |
P value |
|---|---|---|---|---|---|---|
| Burning Sensation in chest | 3 (1) | 0 (1.5) | <0.001 | 75% | 0 | 0.001 |
| Backwash (regurgitation) of food or sour liquid |
2 (1) | 0 (1) | <0.001 | 66% | 0 | 0.001 |
| Upper abdominal or chest pain | 2 (1) | 0 (2) | <0.001 | 66.67% | 0 | 0.001 |
| Trouble swallowing (dysphagia) | 1 (2) | 0 (0.5) | 0.01 | 41.66% | 0 | 0.01 |
| Sensation of a lump in your throat | 2 (1) | 0 (1) | <0.001 | 66.67% | 0 | 0.001 |
| An ongoing cough | 2 (1) | 0 (1) | <0.001 | 66.67% | 0 | 0.001 |
| Inflammation of the vocal cord (laryngitis) |
0.5 (1.75) | 0 (0.5) | 0.006 | 0 | 0 | 0.005 |
• The severity of symptoms in the GUT RESET group have shown to reduce over the period of 60 days.
Assessment of Frequency of Gastroesophageal Symptom Assessment Scale (GSAS) from Baseline to End of Study
| Symptom | Group 1 GUT RESET |
Group 2- PLACEBO |
P value | Group 1 GUT RESET |
Group 2 PLACEBO |
P value |
|---|---|---|---|---|---|---|
| Burning Sensation in chest Backwash (regurgitation) of food or sour liquid |
4 (0) | 0 (2) | <0.001 | 100% | 0 | 0.001 |
| Upper abdominal or chest pain | 3 (1) | 0 (2) | <0.001 | 100% | 0 | 0.001 |
| Trouble swallowing (dysphagia) | 3 (1) | 0 (1.5) | <0.001 | 100% | 0 | 0.001 |
| Trouble swallowing (dysphagia) | 2.5 (3) | 0 (1) | 0.004 | 100% | 25% | 0.001 |
| Sensation of a lump in your throat | 2.5 (1) | 1 (2) | <0.001 | 100% | 50% | 0.001 |
| An ongoing cough | 3 (1) | 0 (1) | <0.001 | 100% | 0 | 0.001 |
| Inflammation of the vocal cord (laryngitis) |
0 (2) | 0 (0) | 0.012 | 0 | 0 | 0.012 |
The frequency of symptoms completely resolved in the GUT RESET group by the end of 60 days.
Inter Group Comparison of Improvement in Dyspepsia Symptoms during Follow up
| Change in Severity [Median (IQR)] | |||
|---|---|---|---|
| Symptom | Group 1 GUT RESET |
Group 2- PLACEBO | P value |
| Relief in upper abdominal fullness | 20% | 0 | 0.07 |
| Reduction in upper abdominal pain | 0 | 0 | 0.03 |
| Reduction in Belching | 20% | 0 | 0.04 |
| Reduction in Bloating | 16.67% | 0 | 0.04 |
| Relief from Early satiety | 16.67% | 0 | 0.03 |
| Reduction in Nausea | 16.67% | 0 | 0.002 |
| Decrease in Vomiting | 16.67% | 0 | 0.004 |
| Reduction in Regurgitation (backwash) | 16.67% | -50% | 0.007 |
| Reduction in burning sensation if chest (heartburn) | 16.67% | -50% | 0.035 |
| Improvement in Appetite | 16.67% | -50% | 0.004 |
Resolution of Clinical Symptoms by End of Study
| Clinical Symptoms | GUT RESET | PLACEBO | p value | ||
|---|---|---|---|---|---|
| Absent (%) | Present (%) | Absent (%) | Present (%) | ||
| Upper Abdominal/ Chest Pain | 95.83% | 4.17% | 12% | 88% | 0.001 |
| Trouble Swallowing (Dysphagia) | 100% | 0 | 72% | 28% | 0.005 |
| Sensation of a lump in your Throat | 100% | 0 | 28% | 72% | 0.001 |
| An Ongoing Cough | 100% | 0 | 8% | 92% | 0.001 |
| Inflammation of the Vocal Cord | 100% | 0 | 60% | 28% | 0.001 |
| New or Worsening Asthma | 100% | 0 | 96% | 4% | 0.32 |
| A Burning sensation in your chest | 91.67% | 8.33 | 0 | 100% | 0.001 |
| Backwash | 70.83% | 29.17 | 0 | 100% | 0.001 |
OVERALL CONCLUSIONS
•
GUT RESET capsules showed significant effect on the reduction of the severity and frequency of GER symptoms measured using GSAS scale over the period of 60 days.
•
The difference in the severity and frequency of various symptoms namely burning sensation in chest, backwash of food, upper abdominal or chest pain, dysphagia, sensation of lump in the throat, ongoing cough and inflammation of vocal cord from baseline to the end of study was higher in the GUT RESET group when compared to placebo. This difference was found to be statistically highly significant.
•
The safety evaluation reinforces the favourable safety profile of GUT RESET capsules, with the absence of adverse events and the maintenance of key laboratory and vital signs parameters within acceptable ranges.
