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CTRI Number  CTRI/2025/09/095119 [Registered on: 19/09/2025] Trial Registered Prospectively
Last Modified On: 22/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A randomized placebo-controlled clinical trial to evaluate the efficacy of the standardized homoeopathic remedy Gelsemium sempervirens versus placebo in reducing performance anxiety among junior college students assessed using the Academic Anxiety Scale. 
Scientific Title of Study   A randomized placebo-controlled clinical trial on the efficacy of a standardized homeopathic remedy Gelsemium sempervirens in the management of performance anxiety disorders among junior college student 
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 Shaina Bronika James  
Designation  PG Scholar 
Affiliation  Bharati Vidyapeeth (Deemed to be a University), Homoeopathic medical college and Hospital 
Address  Bharati vidyapeeth (Deemed to be a University), Homoeopathic medical college and Homoeopathic Hospital, Department of postgraduate and Research Centre, Pune

Pune
MAHARASHTRA
411043
India 
Phone  7089078740  
Fax    
Email  shaina.james-hmcpune@bvp.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Poonam P Rathi 
Designation  MD (Hom) 
Affiliation  Bharati Vidyapeeth (Deemed to be a University), Homoeopathic medical college and Hospital 
Address  Bharati Vidyapeeth (Deemed to be a University), Homoeopathic medical college and Homoeopathic Hospital, Department of postgraduate and Research Centre, Pune

Pune
MAHARASHTRA
411043
India 
Phone  9665745589  
Fax    
Email  poonam.rathi@bharatividyapeeth.edu  
 
Details of Contact Person
Public Query  
Name  Dr Poonam P Rathi 
Designation  MD (Hom) 
Affiliation  Bharati Vidyapeeth (Deemed to be a University), Homoeopathic medical college and Hospital 
Address  Bharati Vidyapeeth (Deemed to be a University), Homoeopathic medical college and Homoeopathic Hospital, Department of postgraduate and Research Centre, Pune

Pune
MAHARASHTRA
411043
India 
Phone  9665745589  
Fax    
Email  poonam.rathi@bharatividyapeeth.edu  
 
Source of Monetary or Material Support  
Bharati vidyapeeth (Deemed to be University), Homoeopathic medical college and Homoeopathic Hospital, Department of postgraduate and Research Centre, Pune 
 
Primary Sponsor  
Name  Dr Shaina Bronika James 
Address  Bharati Vidyapeeth (Deemed to be University), Homoeopathic Medical College and Homoeopathic Hospital, Department of Postgraduate and Research Centre, Pune, Maharashtra, India. 411043 
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 Shaina Bronika James  BVDU Homoeopathic Medical College and Hospital, Dept. of postgraduate and Research Center, Pune  Homoeopathic Materia Medica OPD, Department of HMM, Katraj, Dhankawadi, Pune 411043
Pune
MAHARASHTRA 		 7089078740

shaina.james-hmcpune@bvp.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Bharati Vidyapeeth (DTU) HMC, Pune  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F418||Other specified anxiety disorders,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Gelsemium sempervirens  Standardized homeopathic remedy Gelsemium sempervirens is administered orally in the required potency (30C to 1M) in the centesimal scale as per homeopathic posology. The medicine will be dispensed in powder, globules, or liquid form, depending on the need of the patient. 
Comparator Agent  Placebo  Placebo identical in appearance, taste, and mode of administration to the intervention group but containing no active ingredient. Administered orally on the same schedule as the intervention. 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  20.00 Year(s)
Gender  Both 
Details  1. Junior college students aged 15 to 20 years of both genders.
2. Academic Anxiety Scale (AAS) score greater than 11.
3. Not receiving any other form of treatment for anxiety disorder.
4. Willing to participate and provide written informed consent. 
 
ExclusionCriteria 
Details  1. Students with severe psychiatric illnesses, including major depressive disorder, bipolar disorder, psychotic disorder and schizophrenia.
2. Currently using any psychiatric medication. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment    
Blinding/Masking   Participant Blinded 
Primary Outcome
Modification(s)  
Outcome  TimePoints 
Reduction in performance anxiety symptoms measured by Academic Anxiety Scale (AAS) scores.  Assessment will be done at baseline and at the end of 6 months using the Academic Anxiety Scale. 
 
Secondary Outcome
Modification(s)  
Outcome  TimePoints 
Change in anxiety scores (Academic Anxiety Scale) comparison between intervention & placebo groups over the study period.  Assessment will be done at baseline & at the end of 6 months using the Academic Anxiety Scale. 
 
Target Sample Size   Total Sample Size="52"
Sample Size from India="52" 
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   N/A 
Date of First Enrollment (India)   23/09/2025 
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 Yet Recruiting 
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
Modification(s)  
This is a randomized, placebo-controlled clinical trial. The primary objective of the study is to determine whether the standard homoeopathic remedy Gelsemium Sempervirens provides reduction in performance anxiety symptoms as compared to a placebo. The study is being conducted at Bharati Vidyapeeth (deemed to be university) Homoeopathic Medical College and Hospital, including OPD, IPD, and various rural and urban camps conducted by the hospital. Participants will be screened using inclusion and exclusion criteria, and only those with a baseline Academic Anxiety Scale (AAS) score greater than 11 will be considered for the study. Comprehensive case taking will be performed for those whose academic anxiety scale score is greater than 11. Participants would be randomly assigned to either group A or group B with the help of a computer randomization technique. Group A  will be receiving Gelsemium Sempervirens. Group B will receive a placebo. Follow-up will be done every month, and assessment by using the academic anxiety rating scale will be done. 
 
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