A Three-Group study to know the Effect of Sublingual Brahmi (Bacopa Monnieri) Drops in Managing Stomach Pain

An Open-Labelled Three-Armed Randomized Controlled Clinical Trial To Evaluate The Effect Of Sub-Lingual Brahmi (Bacopa Monnieri) Drops In The Management Of Abdominal Colic - NIL

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/03/083591

Enrollment

Registered

2025-03-27

Start date

Unknown

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: R108- Other abdominal pain

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: a. Participants aged between 18 and 60 years. b. Patients presenting with abdominal colicky pain that does not require immediate surgical intervention. c. Patients diagnosed with the following conditions, where Brahmi (Bacopa monnieri) drops may be beneficial: i. Multiple urinary calculi (unilateral or bilateral) without accompanying hydronephrosis. ii. Cholecystitis and cholelithiasis without severe complications. iii. Abdominal cramps and biliary colic. iv. Dysmenorrhea (painful menstruation). v. Appendicitis not necessitating immediate surgical intervention. d. Patients of all genders, regardless of caste, religion, and socio-economic status.

Exclusion criteria

Exclusion criteria: 1. Patients with renal or ureteric calculi that are accompanied by severe hydronephrosis, which requires immediate or urgent intervention. 2. Individuals with obstructive renal calculi leading to severe infections, such as pyelonephritis, that necessitate immediate medical treatment. 3. Patients diagnosed with obstructive jaundice, a condition requiring urgent management due to bile duct obstruction, often caused by gallstones or tumors. 4. Any patient with a condition requiring immediate surgical intervention, such as: 1. Complete bowel obstruction. 2. Perforated appendix. 3. Any other acute abdominal condition that mandates urgent surgery. 5. Patients with severe systemic conditions, such as uncontrolled diabetes or cardiovascular disease, that may complicate the management of abdominal colic or interfere with the study outcomes. 6. Pregnant or breastfeeding women, due to potential risks and lack of sufficient safety data on the use of Brahmi (Bacopa monnieri) drops in these populations. 7. Patients Who are not willing to give consent.

Design outcomes

Primary

Measure	Time frame
Decrease in Pain, Decrease in VAS Pain Score, Decrease in intensity and duration of pain, Decrease in following criteria of coliky pain 1.Tenderness 2.Nausea 3.Vomiting 4.Diarrhoea 5.Fatigue 6.Fainting Timepoint: Intervention will be done for 3 day, assessment will be done on 3rd day + follow up will be done on 7th day.	—

Secondary

Measure	Time frame
Improve overall quality of lifeTimepoint: 3 DAYS	—

Countries

India

Contacts

Public ContactDr Harish Daga

Parul Institute of Ayurved

harish.daga26839@paruluniversity.ac.in9428563415

Outcome results