CTRI

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CTRI Number

CTRI/2025/03/083591 [Registered on: 27/03/2025] Trial Registered Prospectively

Last Modified On:

25/03/2025

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Drug
Ayurveda

Study Design

Randomized, Parallel Group, Multiple Arm Trial

Public Title of Study

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

Scientific Title of Study

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

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

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

Name	Dr Kajal Patel
Designation	Post Graduate
Affiliation	Parul Institute of Ayurved
Address	Room No 403 Deparment of Shalya Tantra, Parul Institute of Ayurved, Parul University, Post Limda, Waghodia, Gujarat 391760 Vadodara GUJARAT 291760 India Vadodara GUJARAT 391760 India
Phone	8140448970
Fax
Email	kajal.kkpatel8442@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Harish Daga
Designation	Associate Professor
Affiliation	Parul Institute of Ayurved
Address	Room No 403 Deparment of Shalya Tantra, Parul Institute of Ayurved, Parul University, Post Limda, Waghodia, Gujarat 391760 Vadodara GUJARAT 291760 India Vadodara GUJARAT 391760 India
Phone	9428563415
Fax
Email	harish.daga26839@paruluniversity.ac.in

Details of Contact Person
Public Query

Name	Dr Harish Daga
Designation	Associate Professor
Affiliation	Parul Institute of Ayurved
Address	Room No 403 Deparment of Shalya Tantra, Parul Institute of Ayurved, Parul University, Post Limda, Waghodia, Gujarat 391760 Vadodara GUJARAT 291760 India Vadodara GUJARAT 391760 India
Phone	9428563415
Fax
Email	harish.daga26839@paruluniversity.ac.in

Source of Monetary or Material Support

PARUL AYURVED HOSPITAL Parul University Taluka Waghodia District Vadodara State Gujarat India Pincode-391760

Primary Sponsor

Name	Dr Kajal Patel
Address	Room No 403 Deparment of Shalya Tantra, Parul Institute of Ayurved, Parul University, Post Limda, Waghodia, Gujarat 391760 Vadodara GUJARAT India
Type of Sponsor	Other [Self]

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 Kajal Patel	Parul Ayurved Hospital	Shalya OPD No 106 Parul Ayurved Hospital, Parul University, Post Limda, Waghodia, Gujarat 391760 Vadodara GUJARAT	8140448970 kajal.kkpatel8442@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Parul Institute of Ayurved	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition:R108\|\|Other abdominal pain. Ayurveda Condition: SULAH,

Intervention / Comparator Agent

sno	Intervention/Comparator	Type	Drug-Type	Procedure Name	Details
1	Intervention Arm	Drug	Other than Classical		(1) Medicine Name: Brahmi , Reference: NA, Route: Oral, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 1(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Days, anupAna/sahapAna: No, Additional Information: -
2	Comparator Arm	Drug	Other than Classical		(1) Medicine Name: Brahmi , Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Days, anupAna/sahapAna: No, Additional Information: -
3	Comparator Arm (Non Ayurveda)		-	Drug	Medicine: Mefenamic acid IP 250mg Dicyclomine Hydrochloride IP 10mg Route: Oral Dosage form: Tablet Dose: 1 tablet Frequency: bd Duration: 3days

Inclusion Criteria

Age From	18.00 Year(s)
Age To	60.00 Year(s)
Gender	Both
Details	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.

ExclusionCriteria

Details

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.

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

Case Record Numbers

Blinding/Masking

Open Label

Primary Outcome

Outcome	TimePoints
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	Intervention will be done for 3 day, assessment will be done on 3rd day + follow up will be done on 7th day.

Secondary Outcome

Outcome	TimePoints
Improve overall quality of life	3 DAYS

Target Sample Size

Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"

Phase of Trial

Phase 3/ Phase 4

Date of First Enrollment (India)

15/04/2025

Date of Study Completion (India)

Applicable only for Completed/Terminated trials

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Applicable only for Completed/Terminated trials

Estimated Duration of Trial

Years="1"
Months="6"
Days="0"

Recruitment Status of Trial (Global)

Not Applicable

Recruitment Status of Trial (India)

Not Yet Recruiting

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

The primary objective of this study is to evaluate and compare the efficacy of Brahmi extract in two forms sublingual drops and capsules against a conventional pharmaceutical treatment comprising Mefenamic Acid and Dicyclomine Hydrochloride for the management of abdominal colic. The secondary objective is to preparation of brahmi drops and brahmi capsule. Analytical study of drops and capsule.The trial follows an open-labelled, three-armed, randomized controlled design with a sample size of 60 patients, divided into three groups of 20 each. The study spans 10 days, including a 3-day treatment period and a 7-day follow-up. Participants will be assessed based on subjective criteria such as pain intensity, duration, and location, as well as objective criteria like tenderness, nausea, vomiting, diarrhea, fatigue, and fainting, using standardized assessment scales.