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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  
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 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  
Status 
Not Applicable 
 
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.

 
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