Introduction to Gut Reset

Introduction to Gut Reset

Gut Reset is a revolutionary supplement designed to support optimal gut health. Comprised of natural ingredients, Gut Reset helps maintain a healthy balance of gut flora, essential for digestion and overall well-being. By promoting the growth of beneficial bacteria and inhibiting harmful pathogens, Gut Reset enhances nutrient absorption, boosts immune function, and contributes to better digestive comfort. This supplement is perfect for individuals seeking a natural way to improve their gut health and achieve a healthier lifestyle.

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How Gut Reset Enhances Overall Well-being

Beyond improving digestion, Gut Reset offers a range of benefits that contribute to overall well-being. A healthy gut is closely linked to a strong immune system, as a significant portion of immune cells reside in the digestive tract. By fostering a balanced gut microbiome, Gut Reset helps enhance immune response and protect against infections. Furthermore, a well-functioning gut can positively impact mental health, as the gut-brain axis influences mood and cognitive function. Users of Gut Reset often report feeling more energetic, less bloated, and experiencing a greater sense of well-being, making it an essential addition to any health regimen.

SummaryClinical Study 1

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

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.