| CTRI Number |
CTRI/2025/11/098155 [Registered on: 27/11/2025] Trial Registered Prospectively |
| Last Modified On: |
27/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy Screening Behavioral |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A study to see how Brahmi (Bacopa monnieri) helps reduce exam stress in college students. |
|
Scientific Title of Study
|
A randomized single blind placebo-controlled 12 weeks study to know the efficacy of Bacopa Monnieri (Brahmi) mother tincture in managing Examination Funk in 18 - 25 years age group students by using examination anxiety scale |
| 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 Diksha Goyal |
| Designation |
Assistant Professor |
| Affiliation |
HOMOEOPATHY UNIVERSITY |
| Address |
M N Homoeopathic medical college hospital and research institute bikaner rajasthan HOMOEOPATHY UNIVERSITY
Department of Homoeopathic Materia Medica University Campus
Saipura Sanganer
Jaipur 302029 Rajasthan (India) Jaipur RAJASTHAN 334001 India |
| Phone |
9587588665 |
| Fax |
|
| Email |
dgoyal93@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Jyoti Sharma |
| Designation |
Associate Professor |
| Affiliation |
Homoeopathy University |
| Address |
HOMOEOPATHY UNIVERSITY
Office Address and University Campus
Saipura Sanganer
Jaipur 302029 Rajasthan (India)
Jaipur RAJASTHAN 302029 India |
| Phone |
9785835468 |
| Fax |
|
| Email |
jyotisharmasky11@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Diksha Goyal |
| Designation |
Assistant Professor |
| Affiliation |
homoeopathy university |
| Address |
HOMOEOPATHY UNIVERSITY
Office Address and University Campus
Saipura Sanganer
Jaipur 302029 Rajasthan (India)
Bikaner RAJASTHAN 302029 India |
| Phone |
958758865 |
| Fax |
|
| Email |
dgoyal93@gmail.com |
|
|
Source of Monetary or Material Support
|
| self funded
M N Homoeopathic Medical College Hospital and RI Bikaner Rajasthan |
|
|
Primary Sponsor
|
| Name |
Dr Diksha Goyal |
| Address |
M N Homoeopathic Medical College Hospital & RI Bikaner Rajasthan 334022
near garden city naino ka bas jaipur jodhpur highway (India) |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Diksha Goyal |
Homoeopathy University |
HOMOEOPATHY UNIVERSITY
Dept of Homoeopathic Materia Medica University Campus
Saipura Sanganer
Jaipur 302029 Rajasthan (India) Jaipur RAJASTHAN |
09587588665
dgoyal93@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Homoeopathy University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Undergraduate students aged 18-25 years.
Experiencing symptoms of examination funk
Including anxiety, cognitive impairment, and physical discomfort by using examination anxiety scale |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bacopa Monnieri (Brahmi) Mother Tincture |
Students will be screened, then given either Brahmi mother tincture or placebo during exam preparation and exams with regular follow-ups. Bacopa monnieri (Brahmi) Mother Tincture, 10 drops in half cup of water, taken orally twice daily for 12 weeks.
|
| Comparator Agent |
placebo mother tincture |
Students will be screened, then given either Brahmi mother tincture or placebo during exam preparation and exams with regular follow-ups.
Anxiety, cognition, and exam performance will be compared before and after to assess Brahmi’s efficacy. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
Undergraduate students aged 18-25 years. Experiencing symptoms of examination funk including anxiety cognitive impairment and physical discomfort |
|
| ExclusionCriteria |
| Details |
Students with underlying medical conditions Known cases of psychiatric disorders Generalized Anxiety Disorder as per the Hamilton Anxiety scale those taking other supplements or medications that may interfere with the study. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Significant reduction in anxiety and improvement in cognitive function in the experimental group compared to the control group |
outcome of study will be assessed by using EAS a pre and post treatment scores of EAS will be compared every three months for a total period of 9 months in the students with examination funk in students of age 18 to 25 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="146" Sample Size from India="146"
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 2 |
|
Date of First Enrollment (India)
|
12/12/2025 |
| 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="0" Months="9" 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form Response - Clinical Study Report Response - Analytic Code
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [dgoyal93@gmail.com].
- For how long will this data be available start date provided 15-09-2026 and end date provided 15-10-2027?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
The purpose of this study is to evaluate the efficacy of Brahmi supplementation in alleviating the symptoms of examination funk among university students. Specifically, the study will assess whether Brahmi can reduce anxiety, enhance cognitive function, and improve physical symptoms like fatigue and sleep disturbances, thereby improving overall exam performance. Brahmi, also known as Bacopa monnieri, is a well-known medicinal herb used extensively in Ayurveda and Homoeopathy as a nervine tonic. It is considered a nootropic, enhancing cognitive functions such as memory, concentration, and learning ability. In homoeopathy, it is primarily prescribed for neurological disorders, mental fatigue, anxiety, and stress-induced ailments. Examination anxiety is a significant issue among adolescents, and young adults affecting their mental health and academic performance. While Brahmi (Bacopa monnieri) is traditionally recognized for its calming and cognitive-enhancing effects, no prior research has specifically evaluated its efficacy in managing examination funk within the context of Homoeopathy. This study aims to address this gap by conducting a randomized placebo-controlled trial to assess the effectiveness of Brahmi mother tincture in reducing examination anxiety. Using a culturally relevant and standardized Examination Anxiety Scale for Adolescents, this research represents a novel contribution to Homoeopathy and adolescent mental health management.
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