| 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
|
|
|
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
|
|
|
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. |