| CTRI Number |
CTRI/2024/04/066301 [Registered on: 25/04/2024] Trial Registered Prospectively |
| Last Modified On: |
01/05/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
EFFECT OF THE HOMOEOPATHIC MEDICINES IN ACUTE PAIN |
|
Scientific Title of Study
|
A RANDOMIZED CONTROLLED TRIAL TO ASSESS THE EFFECTIVENESS OF INDIVIDUALIZED HOMOEOPATHIC MEDICINES IN ACUTE PAIN |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ADITI CHADHA |
| Designation |
PG SCHOLAR |
| Affiliation |
Sri Ganganagar Homoeopathic Medical College Hospital and Research Institute |
| Address |
Department of Organon of Medicine
First Floor
Sri Ganganagar Homoeopathic Medical College Hospital and Research Institute
Tantia University
Near Riico Bus Stand Hanumangarh Road Sri Ganganagar
Ganganagar
RAJASTHAN
335002
India |
| Phone |
8130773036 |
| Fax |
|
| Email |
addyc340@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
SUNIL KUMAR |
| Designation |
HOD |
| Affiliation |
Sri Ganganagar Homoeopathic Medical College Hospital and Research Institute |
| Address |
DEPARTMENT OF ORGANON OF MEDICINE
FIRST FLOOR
SRI GANGANAGAR HOMOEOPATHIC MEDICAL COLLEGE HOSPITAL AND RESEARCH INSTITUTE
TANTIA UNIVERSITY
NEAR RIICO BUS STAND HANUMANGARH ROAD
SRI GANGANAGAR
Ganganagar
RAJASTHAN
335002
India |
| Phone |
9460631101 |
| Fax |
|
| Email |
drsunilbishnoi84@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
ADITI CHADHA |
| Designation |
PG SCHOLAR |
| Affiliation |
Sri Ganganagar Homoeopathic Medical College Hospital and Research Institute |
| Address |
DEPARTMENT OF ORGANON OF MEDICINE
FIRST FLOOR
SRI GANGANAGAR HOMOEOPATHIC MEDICAL COLLEGE HOSPITAL AND RESEARCH INSTITUTE
NEAR RIICO BUS STAND HANUMANGARH ROAD
SRI GANGANAGAR
Ganganagar
RAJASTHAN
335002
India |
| Phone |
8130773036 |
| Fax |
|
| Email |
addyc340@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Ganganagar Homoeopathic Medical College, Hospital and Research Institute
Tantia University
Near Riico Bus Stand
Hanumangarh Road
Sri Ganganagar
Rajasthan 335002 |
|
|
Primary Sponsor
|
| Name |
Tantia University |
| Address |
Sri Ganganagar Homoeopathic Medical College Hospital and Research Institute
NEAR RIICO BUS STAND HANUMANGARH ROAD SRIGANGANAGAR |
| 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 |
| ADITI CHADHA |
Sri Ganganagar Homœopathic Medical College Hospital and Research Institute |
DEPARTMENT OF ORGANON OF MEDICINE
FIRST FLOOR
SRIGANGANAGAR HOMOEOPATHIC MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE
TANTIA UNIVERSITY
NEAR RIICO BUS STAND HANUMANGARH ROAD SRIGANGANAGAR
Ganganagar
RAJASTHAN |
8130773036
addyc340@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Sri Ganganagar Homœopathic Medical College Hospital and Research Institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R52||Pain, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Homoeopathy |
Individualized Homoeopathic Drugs
Dose: 50th Millesimal potencies / Centesimal Potencies
Frequency of Dosing: 2 Hourly / 3 Hourly / 4 Hourly / QID / TDS
Route of Administration: Oral
Duration of Intervention: 1 week in each case
|
| Comparator Agent |
Saccharum lactis |
Placebo
Administered 2 Hourly / 3 Hourly / 4 Hourly/ QID/ TDS
Route of intervention: Oral
Duration of intervention: 1 week in each case |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. All the patients presenting with acute pain.
2. Patients of all age group and both sexes.
3. Patients taking a prescription medication (NSAIDs, acetaminophen, and aspirin) episodically (or as needed) for the management of pain, agrees to discontinue its use prior to or at the Screening and Baseline Visit
4. Patients agreeing to not commence any new prescription medication for the management of pain
throughout the study
5. Patients agreeing to not commence any injection therapy for pain during the course of the study
6. Patients agreeing to not use acupuncture, biofeedback, or transcutaneous electrical nerve
stimulation (TENS) for the management of pain during the course of the study.
|
|
| ExclusionCriteria |
| Details |
1. Terminally ill patients. [eg. congestive heart failure, renal failure or dialysis etc.]
2. Patients unwilling to give the consent.
3. Patients with pre-existing opiate therapy; and patients with dependencies on tobacco, alcohol, opioids, or other substances.
4. Patients with angina, bronchospasm, bronchial asthma, bronchospasm (chronic obstructive pulmonary disease and emphysema), diabetes mellitus, hyperthyroidism, fibromyalgia, or uncontrolled seizures or known hypersensitivity.
5. Anything that, in the opinion of the investigator, would place the participant at
increased risk or preclude the participant’s full compliance with or completion of the study
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Visual Analogue Scale (VAS) measuring pain intensity |
Visual Analogue Scale (VAS) at Baseline
And After 1 week of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Health-related quality of life (HRQOL) |
Health-related quality of life (HRQOL) at Baseline & after 1 week of intervention |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "126"
Final Enrollment numbers achieved (India)="126" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
03/05/2024 |
| Date of Study Completion (India) |
09/05/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
09/05/2025 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Pain has been the oldest medical problem but is little understood by the physicians throughout history. Though various analgesic modalities are available, acute pain management plans must be specialized for each patient in view of individual variation. Further, people often look for other modes of treatment such as homoeopathy that have relatively fewer or no side effects. Considering this common use of homeopathy for managing acute pain there is lack of sufficient evidence about its effectiveness, the present randomized controlled trial aimed to examine the effect of homeopathy on acute pain intensity. For the study 100 patients reporting acute pain will be enrolled. Individualized homoeopathic medicines and placebo will be prescribed. The score of pain pre and post medication will be recorded using VAS (Visual Analog Scale). Treatment outcome will be analysed using appropriate statistics.
|