| CTRI Number |
CTRI/2025/01/079395 [Registered on: 24/01/2025] Trial Registered Prospectively |
| Last Modified On: |
18/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To Study the effect of Homoeopathic medicine in Pharyngitis |
|
Scientific Title of Study
|
Prospective clinical study of Homoeopathic intervention for management of Pharyngitis assessed By STAT-10 |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nidhi A. Solanki |
| Designation |
PG scholar |
| Affiliation |
Rajkot Homoeopathic Medical College |
| Address |
Department Of Practice of Medicine, Rajkot Homoeopathic Medical
College, behind jainath complex, makkam chowk, Gondal road,
Rajkot
Rajkot GUJARAT 360002 India |
| Phone |
9327450701 |
| Fax |
|
| Email |
niddhisolanki28@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Hitarth Mehta |
| Designation |
Principal, HOD and PhD scholar |
| Affiliation |
Rajkot Homoeopathic Medical College |
| Address |
Department Of Practice of Medicine, Rajkot Homoeopathic Medical
College, behind jainath complex, makkam chowk, Gondal road,
Rajkot
Rajkot GUJARAT 360002 India |
| Phone |
9825340073 |
| Fax |
|
| Email |
hitarth.mehtarhmc@paruluniversity.ac.in |
|
Details of Contact Person Public Query
|
| Name |
Nidhi A. Solanki |
| Designation |
PG scholar |
| Affiliation |
Rajkot Homoeopathic Medical College |
| Address |
Department Of Practice of Medicine, Rajkot Homoeopathic Medical
College, behind jainath complex, makkam chowk, Gondal road,
Rajkot
Rajkot GUJARAT 360002 India |
| Phone |
9327450701 |
| Fax |
|
| Email |
niddhisolanki28@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rajkot Homoeopathic Medical College atteched with Sainath Hospital, Parul University, Rajkot, Gujarat, India
360002 |
|
|
Primary Sponsor
|
| Name |
Rajkot Homoeopathic Medical College atteched with Sainath Hospital Parul university |
| Address |
B/H jainath petrol pump, Gondal road, Rajkot, Gujarat, India , 360002 |
| 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 Nidhi A Solanki |
Rajkot Homoeopathic Medical College atteched with Sainath Hospital |
Practice of medicine OPD
B/H jainath petrol pump, Gondal road, Rajkot, Gujarat, India Rajkot GUJARAT |
9327450701
niddhisolanki28@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for Human Research - Rajkot Homoeopathic Medical College( RHMC), Parul University, Gujarat |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J029||Acute pharyngitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
INDIVIDUALISED HOMOEOPATHIC MEDICINE |
Individualized homoeopathic
medicine. Mode of Administration: Oral (sublingual) Selection of potency, dose and repetition : individualised medicine will be prescribed in 30, 200, 1 M potency. selection of dosage, potency and repetition will be according to susceptibility of patient and principles of organon of medicine |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged 5-15years.
Both genders (Male and Female) will be considered.
Diagnostic criteria mainly done basis of prediagnosed cases or diagnosed by history presentation and physical examinations or laboratory findings
All socio-economical classes are considered
|
|
| ExclusionCriteria |
| Details |
Patients with other systemic illness or serious pathological conditions, autoimmune conditions.
Patients above 15years and below 5 years of age.
Patients taking other therapeutic measures for pharyngitis
Other respiratory diseases, irreversible pathological changes and immunocompromised patient
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
There will be some improvement after prescribing Homoeopathic Medicines
|
There will be some improvement after prescribing Homoeopathic Medicines
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Cure- complete relief in all symptoms, no recurrence with sense of well being.
Improved - decreased throat pain, difficulty in swallowing & fever with sense of well being.
Status que - all symptoms as it is. |
There will be some improvement after prescribing Homoeopathic Medicines after 9 months
|
|
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
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 3 |
|
Date of First Enrollment (India)
|
16/07/2025 |
| 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="0" Months="9" 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
|
Introduction : The prevalence rate of sore throat is around 10% of people visiting primary healthcare services each year. Sore throat is the most common presenting symptom and one of the most common reasons for ambulatory care visits by adults and children. Acute pharyngitis is a common and debilitating condition affecting millions worldwide, resulting in significant healthcare utilization and economic burden. Despite its prevalence, diagnosis and management remain challenging due to Limited understanding of the pathogenesis and epidemiology, Overuse and misuse of antibiotics, Emerging antibiotic resistance, adverse effect, Lack of effective prevention strategies, Variable clinical presentation and severity etc. Each year, pharyngitis is responsible for more than 40 million visits to health care providers. Most children and adults experience 3-5 viral upper respiratory tract infections (including pharyngitis) per year. it is diagnosed in more than 2 million people per year in India. The pooled prevalence rate of pharyngitis in children aged 5–15 years in India is estimated to be 22.66%. Homeopathy is known for its holistic approach to patient care, considering individual symptoms, lifestyle, and emotional well-being. Examining the holistic aspects of homeopathic treatments may contribute to a more comprehensive understanding of managing pharyngitis. RESEARCH QUESTION : Whether the patient suffering from pharyngitis will get beneficial result after taking homoeopathic medicines ? Hypothesis: Null Hypothesis (H0): There is no significant difference in the treatment outcomes for pharyngitis individuals receiving homoeopathic intervention. Alternative Hypothesis (H1): There is a significant difference in the treatment outcomes for pharyngitis individuals receiving homoeopathic intervention. |