| CTRI Number |
CTRI/2024/01/062169 [Registered on: 31/01/2024] Trial Registered Prospectively |
| Last Modified On: |
06/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Role of Homoeopathic medicines in the treatment of fever |
|
Scientific Title of Study
|
A Randomized Clinical Trial to evaluate the effectiveness of Millesimal and Centesimal Potencies of Homoeopathic Medicines in the management of Pyrexia in Adults Using FAST Tool |
| 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 Jeswin Abraham |
| Designation |
PG scholar |
| Affiliation |
Vinayaka Missions Homoeopathic Medical College and Hospital |
| Address |
Department of Organon of Medicine
Opd Room no 2e1
Vinayaka Missions Homoeopathic Medical College and Hospital
NH47 Sankari Main road Seeragapadi
Salem
Salem TAMIL NADU 636308 India |
| Phone |
9895119121 |
| Fax |
|
| Email |
jeswinabrahamv9@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Santi Dheepan |
| Designation |
Assistant professor |
| Affiliation |
Vinayaka Missions Homoeopathic Medical College and Hospital |
| Address |
Department of Organon of Medicine
Opd Room no 2e1
Vinayaka Missions Homoeopathic Medical College and Hospital
NH47 Sankari Main road Seeragapadi
Salem
Salem TAMIL NADU 636308 India |
| Phone |
9986076195 |
| Fax |
|
| Email |
santiagobear93@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Santi Dheepan |
| Designation |
Assistant professor |
| Affiliation |
Vinayaka Missions Homoeopathic Medical College and Hospital |
| Address |
Department of Organon of Medicine
Opd Room no 2e1
Vinayaka Missions Homoeopathic Medical College and Hospital
NH47 Sankari Main road Seeragapadi
Salem
Salem TAMIL NADU 636308 India |
| Phone |
9986076195 |
| Fax |
|
| Email |
santiagobear93@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vinayaka Mission Homoeopathic Medical College and Hospital NH47 Sankari Main road
Seeragapadi
Salem
Tamilnadu
|
|
|
Primary Sponsor
|
| Name |
Vinayaka Missions Homoeopathic Medical College and Hospital |
| Address |
NH47 Sankari Main road Seeragapadi
Salem
Tamilnadu
636308
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 |
| Dr Jeswin Abraham |
Vinayaka Missions Homoeopathic Medical College and Hospital |
Department of Organon of Medicine
Opd Room no 2e1
Vinayaka Missions HomoeopathiC Medical College and Hospital
NH47 Sankari Main road
Seeragapadi
Salem Salem TAMIL NADU |
9895119121
jeswinabrahamv9@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Vinayaka Missions Kirupananda Variyar Medical College and Hospital Salem |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R509||Fever, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Centesimal potency Homoeopathic medicine |
Required Homoeopathic medicine in centesimal potency is selected based on the symptom similarity and administered in water dose (1 drop of medicine is dissolved in 20 teaspoon (100 ml) full of distilled water). The medicine is administered 1 teaspoon (5ml) of medicated solution orally every half hour till betterment occurs. The temperature is monitored every one hour till fever subsides. After administration of medicine the patient is kept under admission in IPD or under observation for about four hours. |
| Comparator Agent |
Millesimal potency Homoeopathic medicine |
Required Homoeopathic medicine in millesimal potency is selected based on the symptom similarity and administered in water dose (1 pill of medicine is dissolved in 20 teaspoon full of distilled water). The medicine is administered 1 tsp of medicated solution orally every half hour till betterment occurs. The temperature is monitored every one hour till fever subsides. After administration of medicine the patient is kept under admission in IPD or under observation for about
four hours. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients of age group between 18 – 60 yrs.
2.Both sexes
3.Diagnostic criteria are mainly based on the clinical presentation. |
|
| ExclusionCriteria |
| Details |
1.Patients below 18 yrs.Â
2.Adults above 60 yrs.
3.Temperature above 102.2 °F
4.Patients who reported after twenty four hours of onset.
5.Patients who have taken medications other than Homoeopathic prescription for the same.
6.Patients who are suffering from life-threatening diseases, advanced stages of long-standing diseases.
7.Patients who are immune-compromised .
8.Patients who fails to get betterment of temperature parameters within maximum of two hour after administration of first dose. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the degree of fever reduction by fifty millesimal potency and centesimal potency . |
One year and three months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of fever reduction in millesimal and centesimal potencies. |
one year three and months |
| To assess patient satisfaction and comfort using FAST tool. |
one year and three months |
| To evaluate the speed of recovery in both of the potency scales using FAST tool. |
one year and three months |
| To gauge the ease of administration for healthcare professionals. |
one year and three months |
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/03/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1" Months="3" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
In Homoeopathy, acute diseases are classified into epidemic outbreaks, sporadic instances, and uniquely individual cases. The ideal Homoeopathic treatment hinges on a comprehensive understanding of the characteristic symptoms presented by the patient. This is complemented by identifying the root cause of the disease’s exciting factor. Any changes or deviations in the patient’s overall health, often termed ‘altered generals’, are also given prime consideration. However, certain aspects remain debated even within the well-defined boundaries of Homoeopathic practice. One such aspect is selection of required potency. Finding the right balance and determining the most effective dose is crucial, especially when the stakes are as high as they are with fever management. The scales used for prescription are decimal, centesimal and millesimal. Among these decimal and centesimal potencies are widely used and well proven. But certain debates are going on the path of millesimal scale. The fifty millesimal scale or the LM scale was introduced in the sixth edition of Organon of medicine in the year 1921 mainly for the reason that remedies may be required to be repeated. In order to decrease the drug quantity in the dose and to minimalise aggravation even during the management of chronic diseases, this particular scale was introduced. The primary reason for the different opinions is that the concept was published after the death of master Hahnemann. As a result many of the practitioners are reluctant in accepting the scale. As a result worldwide research for validating the utility and the scope of this scale is not done extensively when comparing with the other two scales. This research seeks to navigate this complex terrain. The primary objective is to analyse the efficiency of fifty millesimal potency and centesimal potency in fever management within the homoeopathic context. Also the speed of recovery in both of the scales is evaluated and compared. By shedding light on this subject, the study aims to clarify and chart a more straightforward path for practitioners in the area of management of acute pyrexia. The Organon of Medicine provides a comprehensive account of treating acute diseases using homoeopathic medicines. The Central Council for Research in Homeopathy (CCRH) has actively explored the efficacy of Homoeopathy in managing acute diseases, leading to the publication of numerous articles. Notably, the CCRH Best Dissertation Awards recognize outstanding studies on homoeopathic medicines in the context of acute and chronic diseases. This research also aims to substantiate the effectiveness of homoeopathic medicines, specifically in treating fever. |