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CTRI Number  CTRI/2025/04/084096 [Registered on: 04/04/2025] Trial Registered Prospectively
Last Modified On: 03/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Improving Brain Response with Homoeopathy: Comparing Millesimal and Centesimal Potencies Using Reaction Time Tests 
Scientific Title of Study   Homoeopathic Management of Neurological Perfromance: A Comparative study of Millesimal and Centismal Potencies using Reaction Time Assessment 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Srinidhi Raman 
Designation  UG Scholar (Intern) 
Affiliation  Venkateswara Homoeopathic Medical College and Hospital 
Address  Department of Homoeopathic Pharmacy 4/11, Samayapuram Main Road, Karambakkam, Porur, Chennai Chennai TAMIL NADU

Chennai
TAMIL NADU
600116
India 
Phone  4424760638  
Fax    
Email  srinidhiraman14@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr G Senthil Kumaran 
Designation  Assistant Professor 
Affiliation  Venkateswara Homoeopathic Medical College and Hospital 
Address  Department of Homoeopathic Pharmacy 4/11, Samayapuram Main Road, Karambakkam, Porur, Chennai Chennai TAMIL NADU

Chennai
TAMIL NADU
600116
India 
Phone  9486875128  
Fax    
Email  senthilbhms@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr G Senthil Kumaran 
Designation  Assistant Professor 
Affiliation  Venkateswara Homoeopathic Medical College and Hospital 
Address  Department of Homoeopathic Pharmacy 4/11, Samayapuram Main Road, Karambakkam, Porur, Chennai Chennai TAMIL NADU

Chennai
TAMIL NADU
600116
India 
Phone  9486875128  
Fax    
Email  senthilbhms@gmail.com  
 
Source of Monetary or Material Support  
Venkateswara Homoeopathic Medical College and Hospital, 4/11, Samayapuram Main Road, Karambakkam, Porur, Chennai - 600116 
 
Primary Sponsor  
Name  Venkateswara Homoeopathic Medical College and Hospital 
Address  4/11, Samayapuram Main Road, Karambakkam, Porur, Chennai 
Type of Sponsor  Private medical college 
 
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 G Senthil Kumaran  Venkateswara Homoeopathic Medical College and Hospital  Unit-4, 4/11, Samayapuram Main Road, Karambakkam, Porur, Chennai Chennai TAMIL NADU
Chennai
TAMIL NADU 
9486875128

senthilbhms@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Venkateswara Homoeopathic Medical College and Hospital Institutional Ethics Committee for Human Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F70||Mild intellectual disabilities, (2) ICD-10 Condition: F71||Moderate intellectual disabilities, (3) ICD-10 Condition: G09||Sequelae of inflammatory diseasesof central nervous system, (4) ICD-10 Condition: E114||Type 2 diabetes mellitus with neurological complications, (5) ICD-10 Condition: E05||Thyrotoxicosis [hyperthyroidism], (6) ICD-10 Condition: I10||Essential (primary) hypertension, (7) ICD-10 Condition: I83||Varicose veins of lower extremities,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Individualized Homoeopathic remedy in Millesimal Potency  According to each case and as per the principles of homoeopathic posology and frequency of repetition will be prescribed accordingly for a period of 01 week The intervention will involve administering the indicated homoeopathic medicine in either millesimal potency, prepared in a 100 ml aqueous solution. A 5 ml dose of the solution will be administered orally, twice daily, for a duration of one week. 
Comparator Agent  Individualized Homoeopathic remedy in Centismal Potency  According to each case and as per the principles of homoeopathic posology and frequency of repetition will be prescribed accordingly for a period of 01 week The intervention will involve administering the indicated homoeopathic medicine in either millesimal or centesimal potency, prepared in a 100 ml aqueous solution. A 5 ml dose of the solution will be administered orally, twice daily, for a duration of one week. 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Individuals with reaction time value above 15 cm in the ruler drop test, Any participants willing, Both healthy and individuals with diagnosed as Essential (primary) hypertension, Mild intellectual disabilities, Moderate intellectual disabilities, Sequelae of inflammatory diseases of central nervous system, Thyrotoxicosis [hyperthyroidism], Type 2 diabetes mellitus with neurological complications, Varicose veins of lower extremities 
 
ExclusionCriteria 
Details  Patients taking prolonged medicines, Patients with critical/ fatal illnesses, Disabled patients, Patients with severe psychological disorders, patients of age other than 40 years – 60 years: children, infants, adolescence and geriatric group 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Participants receiving individualized Homoeopathic treatment (both Millesimal and Centesimal potencies) are expected to show a significant decrease in reaction time (measured by the Ruler Drop Test), indicating improved neurological function and reflex efficiency.
Comparative effectiveness of the potencies will be evaluated
 
Baseline, Day 4 & Day 7 
 
Secondary Outcome  
Outcome  TimePoints 
To assess if the individualised homoeopathic remedy can influence the coexisting health condition along with the neurological functioning.
To assess how quick the medicine given in millesimal potency can act
To assess the diseases which are also associated with RT.
To observe the influence of individualized Homoeopathic remedies on coexisting chronic diseases
 
Baseline, Day 4 & Day 7 
 
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 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="0"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
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  

Reaction Time (RT) is the time taken to respond to a stimulus. it measures the reflex and efficiency of the brain and spine. Assessing RT provides insights into neurological diseases, including one sided disease. Homoeopathy, based on individualization, may influence physiological responses. This study explores the effect of individualized Homoeopathic treatment on RT and reflex responses. this test is a general assessment test which was a gold standard test used for assessing traumatic brain injuries. homoeopathy is a branch of science which deals in treating holistically. it is based on the principle, like cures like, hence it is based on individualised treatment. patients with their symptoms, and the assessment test values are noted and examined and based on their symptoms individualised treatment. the treatment was given in millesimal potency in aqua form for 7 days, thrice a day. follow up and re-examination was done on day 4 and day 7. the results were compared and analysed.

 

Need for the study:

this study is normally done in elderly or children to assess cognitive study, but there are lesser studies showing effectiveness of this study in other neurological diseases and in middle aged adults of 40 - 60-year-olds. Many studies were conducted using complex RT but very tests were only conducted using simple RT test.  This test is used for studies of either infant / children or in elderly, but never used in middle aged adults. Studies have shown repeated RT shows quicker response to stimulus. It also helps in assessing the cognition of a patient In children many learning disabilities and cognitive deficits are identified.  This test also has visual, tactile and auditory response towards the stimulus. But there are no studies in showing efficacy of homoeopathy in such diseases and improvement through such simple tests Further study is necessary in large sample, also assessing the action of homoeopathy in neurological functioning. Role of other chronic diseases like hypertension/ hypothyroidism in neurological functioning and its control through homoeopathic medicine can be studied. A control group can be added and cross verified. Effect of RT in other diseases other than neurological diseases must also be studied in detail. this test further can be used to analyse and assess the effectiveness of homoeopathy in athletes in both functioning and in healing.

 

aim: to evaluate the influence of millesimal potency in homoeopathy on neurological performance by assessing the reaction time in a case series study.

 

objectives:

1. The study aims to evaluate RT in individuals and assess the impact of individualized Homoeopathic remedies, analysing their role in neurological function enhancement.

2. to find the neurological and one-sided diseases associated with rt test

effect of individualised homoeopathic medicines in middle aged adults

effect of rt test as a preliminary test for many other one-sided diseases.

 

hypothesis:

Alternate hypothesis: The administration of millesimal potency in homoeopathic treatments has a measurable effect on neurological performance, as assessed by reaction time tests, in middle aged adults.

Null hypothesis: Millesimal potency of homoeopathic remedy has no significant effect on reaction time in individuals with neurological impairments.

 
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