CTRI

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CTRI Number

CTRI/2025/12/099021 [Registered on: 12/12/2025] Trial Registered Prospectively

Last Modified On:

17/02/2026

Post Graduate Thesis

Type of Trial

Interventional

Type of Study

Drug
Ayurveda

Study Design

Single Arm Study

Public Title of Study

A study to see how safe and useful the product is for people with acidity.

Scientific Title of Study

An Open-Label, Single-Arm, Single-Center Phase 3 Clinical Study to Evaluate the Safety and Efficacy of Gut Arogya in Subjects with Acidity

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
CTSRS/2525 Version No 2.0 Dated 17 Nov 2025	Protocol Number

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr Indushree B S
Designation	Principal Investigator
Affiliation	RVS Ayurvedic Medical College Hospital and Research Centre
Address	Ground Floor R.No-1, Srigandhadakavalu, Vishwaneedam Post, Outer Ring Road, Bangalore KARNATAKA 560091 India
Phone	6364898825
Fax
Email	drbsindushree@gmail.com

Details of Contact Person
Scientific Query

Name	Ms Sathyavathi LM
Designation	HOD-Clinical Operations
Affiliation	Samahitha Research Solutions
Address	Clinical Research Unit, No.1204, "Ashva", 2nd Floor, 26th Main, Jayanagar 9th Block, Bangalore Bangalore KARNATAKA 560091 India
Phone	9739001749
Fax
Email	satyalm@samahitha.com

Details of Contact Person
Public Query

Name	Ms Arpita Malgi
Designation	Team Lead - Clinical Operations
Affiliation	Samahitha Research Solutions
Address	Clinical Research Unit, No.1204, "Ashva", 2nd Floor, 26th Main, Jayanagar 9th Block, Bangalore Bangalore KARNATAKA 560069 India
Phone	06364898825
Fax
Email	arpita@samahitha.com

Source of Monetary or Material Support

Teamworks United LLP 11-D, Sampat farms, Bicholi Mardana road, Opp. Agarwal public school, Indore, Madhya Pradesh - 452016

Primary Sponsor

Name	Teamworks United LLP
Address	11-D, Sampat farms, Bicholi Mardana road, Opp. Agarwal public school, Indore, Madhya Pradesh - 452016
Type of Sponsor	Pharmaceutical industry-Indian

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Indushree B S	RVS Ayurvedic Medical College, Hospital and Research Centre	Ground Floor R.No-1, Srigandhadakavalu, Vishwaneedam Post, Outer Ring Road, Bangalore KARNATAKA	06364898825 drbsindushree@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Pranav Diabetes Center Ethics Committee	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition:K30\|\|Functional dyspepsia. Ayurveda Condition: AMLAPITTAM, (2) ICD-10 Condition:K219\|\|Gastro-esophageal reflux disease without esophagitis. Ayurveda Condition: AMLAPITTAM, (3) ICD-10 Condition:R12\|\|Heartburn. Ayurveda Condition: AMLAPITTAM,

Intervention / Comparator Agent

sno	Intervention/Comparator	Type	Drug-Type	Procedure Name	Details
1	Intervention Arm	Drug	Other than Classical		(1) Medicine Name: Gut Arogyaprash, Reference: NA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -Water), Additional Information: -5 g once daily with ~100 mL lukewarm water on an empty stomach in the morning (alternative: after dinner at night, if morning dosing not feasible) for 30 consecutive days.

Inclusion Criteria

Age From	18.00 Year(s)
Age To	55.00 Year(s)
Gender	Both
Details	1. Male or female, aged 18 to y70ears. 2. History of mild-to-moderate acidity (functional dyspepsia-like symptoms) for at least 6 months prior to screening. 3. Presence of one or more of the following symptoms within the past 7 days prior to screening: - Epigastric burning/pain - Heartburn or retrosternal burning - Bloating - Belching/eructation - Early satiety - Nausea and/or vomiting - Flatulence/gas discomfort 4. Willingness and ability to comply with all study procedures, including daily symptom diaries and study visits. 5. Signed and dated informed consent obtained prior to any study-related procedure. 6. For females of childbearing potential: agreement to use acceptable contraception throughout the study.

ExclusionCriteria

Details

1. Known history or current evidence of serious systemic disease, including:
- Tuberculosis, HIV, HBV, or HCV infection
- Ischemic heart disease, malignancy, chronic renal failure, or chronic liver disease
- Jaundice or clinical evidence of active hepatitis
2. Diagnosis of other functional gastrointestinal disorders (IBS, chronic constipation, ulcer disease, GERD requiring PPI therapy).
3. Presence of diabetes mellitus or hypertension requiring daily medication.
4. Use of any investigational product within 30 days prior to enrollment.
5. Use of prohibited concomitant medications (PPIs, H2 blockers, prokinetics, antibiotics, bismuth salts, NSAIDs, herbal GI remedies) within 7 days prior to baseline.
6. Known allergy, hypersensitivity, or intolerance to any of the components of Gut Arogya.
7. Pregnant or lactating women.
8. Clinically significant laboratory abnormalities (if tested) or any other medical or psychiatric condition that, in the opinion of the Investigator, would make participation unsafe or interfere with study outcomes.

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Open Label

Primary Outcome

Outcome

TimePoints

The primary efficacy endpoint is the change from Baseline (Day 0) to End of Study (Day 30 ±2 days) in acidity-related symptom severity as measured by the 11-point Numeric Rating Scale (NRS; 0 = no symptom, 10 = worst imaginable) for the following symptoms:
- Epigastric burning/pain
- Heartburn/retrosternal burning
- Bloating
- Belching/eructation
- Early satiety
- Nausea and/or vomiting
- Flatulence/gas discomfort
Primary measure:
- Mean change in composite symptom score (average of individual symptom NRS scores).
- Change in frequency of symptomatic episodes (number of episodes in past 7 days, recorded in subject diary).

Day 0 (Visit 1)
Day 15 ±2 (Visit 2)
Day 30 ±2 (Visit 3 or EOS)

Secondary Outcome

Outcome	TimePoints
1. Quality of Life Improvement 2. Global Assessment of Tolerability 3. Safety 4. Treatment Compliance	Day 0 (Visit 1) Day 15 ±2 (Visit 2) Day 30 ±2 (Visit 3 or EOS)

Target Sample Size

Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "20"
Final Enrollment numbers achieved (India)="20"

Phase of Trial

Phase 3

Date of First Enrollment (India)

13/12/2025

Date of Study Completion (India)

21/01/2026

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Date Missing

Estimated Duration of Trial

Years="0"
Months="0"
Days="30"

Recruitment Status of Trial (Global)

Not Applicable

Recruitment Status of Trial (India)

Completed

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
Modification(s)

Brief Summary:
This study aims to evaluate the safety, tolerability, and effectiveness of Gut Arogya, an Ayurvedic formulation, in adults with mild-to-moderate gut acidity (Amlapitta/functional dyspepsia). Approximately 20 participants with a history of recurring acidity for at least 6 months will receive Gut Arogya daily for 30 days. Participants’ symptoms, quality of life, and overall tolerability will be monitored at baseline, Day 15, and Day 30.
Purpose of the Study:
The primary objective is to determine whether Gut Arogya reduces symptoms such as heartburn, bloating, belching, nausea, and early satiety. Secondary objectives include assessing quality of life improvements, safety, tolerability, and treatment compliance, and generating preliminary data for future larger trials.
Result of the study:
This Phase III, open-label, single-arm clinical study demonstrated that Gut Arogya provided meaningful clinical improvement in adults with mild-to-moderate acidity (Amlapitta/functional dyspepsia) over a 30-day treatment period. The primary objectives of the study were successfully met, with participants experiencing a clear reduction in the severity of acidity-related symptoms, as assessed by the Numeric Rating Scale (NRS), along with a notable decrease in the frequency of symptomatic episodes recorded in participant diaries. In addition, clinically meaningful improvements were observed in associated digestive complaints, including gas, constipation, and bloating, indicating broader gastrointestinal symptom relief and improved digestive function. Secondary outcomes further supported the therapeutic benefit of Gut Arogya. Quality of life, measured using the WHOQOL-BREF questionnaire, showed improvement across multiple domains, reflecting enhanced physical, psychological, and environmental well-being, while social health remained stable throughout the study period.
Gut Arogya was well tolerated, with both participant-reported outcomes and investigator assessments confirming good overall acceptability. No serious adverse events were reported, and all observed adverse events were mild, transient, and resolved without medical intervention, supporting a favorable safety profile. High treatment compliance throughout the study reinforced the feasibility and acceptability of daily administration.
In summary, Gut Arogya appears to be a safe, effective, and well-tolerated therapeutic option for the management of mild-to-moderate acidity and related digestive disturbances. By reducing symptom severity and frequency, alleviating associated gastrointestinal symptoms such as gas, constipation, and bloating, and improving overall quality of life, Gut Arogya demonstrates potential as a reliable intervention for comprehensive digestive health management.