| CTRI Number |
CTRI/2024/06/069414 [Registered on: 24/06/2024] Trial Registered Prospectively |
| Last Modified On: |
24/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Homoeopathic management of acute pharyngitis |
|
Scientific Title of Study
|
A prospective study on the homoeopathic management of acute pharyngitis based on Boenninghausens totality. |
| 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 SMRITHY M S |
| Designation |
PG SCHOLAR |
| Affiliation |
Sarada Krishna Homoeopathic Medical College. |
| Address |
IIIrd floor, College Building, Department of Organon
of Medicine, Sarada Krishna Homoeopathic Medical
College, Kulasekharam, Kanniyakumari district,
Tamilnadu.
Kanniyakumari
TAMIL NADU
629161
India |
| Phone |
9446071401 |
| Fax |
|
| Email |
smrithy1998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr MANOJ NARAYAN V |
| Designation |
PROFESSOR |
| Affiliation |
Sarada Krishna Homoeopathic Medical College. |
| Address |
IIIrd floor, College Building, Department of Organon
of Medicine, Sarada Krishna Homoeopathic Medical
College, Kulasekharam, Kanniyakumari district,
Tamilnadu.
Kanniyakumari
TAMIL NADU
629161
India |
| Phone |
9995114518 |
| Fax |
|
| Email |
manojnarayanv@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr MANOJ NARAYAN V |
| Designation |
PROFESSOR |
| Affiliation |
Sarada Krishna Homoeopathic Medical College |
| Address |
IIIrd floor, College Building, Department of Organon
of Medicine, Sarada Krishna Homoeopathic Medical
College, Kulasekharam, Kanniyakumari district,
Tamilnadu.
Kanniyakumari
TAMIL NADU
629161
India |
| Phone |
9995114518 |
| Fax |
|
| Email |
manojnarayanv@gmail.com |
|
|
Source of Monetary or Material Support
|
| INSTITUTION - Sarada krishna homoeopathic medical
college, Kulasekharam, Kanniyakumari district,
Tamilnadu,India
629161
|
|
|
Primary Sponsor
|
| Name |
Post graduate research funded by college |
| Address |
Sarada krishna homoeopathic medical
college, Kulasekharam, Kanniyakumari district,
Tamilnadu.629161
|
| 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 SMRITHY M S |
Sarada Krishna Homoeopathic Medical College |
PG Scholar Department of Organon,Opd,Ipd,Rural Health
Centres, Sarada Krishna
Homoeopathic Medical
College, Kulasekharam,
Kanniyakumari, TamilNadu,629161.
Kanniyakumari
TAMIL NADU |
9446071401
smrithy1998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE SARADA KRISHNA HOMOEOPATHIC MEDICAL COLLEGE |
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 |
| Comparator Agent |
NIL |
NIL |
| Intervention |
SIMILIMUM BASED ON BOENNINGHAUSEN TOTALITY |
Case taking, selection and administration of medicine will be based on Homoeopathic
principles.
Homoeopathic similar remedy is prescribed for the totality of symptom erected on the
basis of Boenninghausen method after detailed case taking.
Intervention of the study is based on disappearance in symptoms in patients before and after homoeopathic management in the duration of 2 weeks.
Pre and post assessment will be analyzed based on the symptomatic relief using Modified Naranjo Criteria for Homoeopathy clinical assessment tool.
|
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients of age group 5-70.
Both sexes.
Patients presenting signs and symptoms of Acute Pharyngitis with onset less than 3 days.
Modified Centor Criteria Score less than 2. |
|
| ExclusionCriteria |
| Details |
Patients with Chronic or Recurrent Pharyngitis, Tonsillitis, other Upper Respiratory Tract
Infections.
Age group below 5 and above 70.
Patients presenting signs and symptoms of Acute Pharyngitis with onset 3 or more days.
Modified Centor Criteria Score with 2 or more.
Individuals with severe underlying medical conditions such as immunodeficiency disorders, autoimmune diseases, or malignancies.
Pregnant or breastfeeding women may be excluded.
Cases in which surgical intervention is necessary. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Effectiveness of Homoeopathic similimum prescribed according to the erected totality
based on Boenninghausen’s method |
2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Symptomatic and general improvement in patient’s condition is evaluated according to
assessment tool. |
2 weeks |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
05/07/2024 |
| 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="2"
Months="0"
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
|
Acute Pharyngitis is a medical condition characterized by the inflammation of the pharynx. It stands out as one of the most prevalent upper respiratory ailments encountered in clinical practice, particularly among pediatric patients in India. The prevalence of Group A Pharyngitis (GAS) in this demographic varies from 4.2 to 13.7%. Streptococcus pyogenes (group A beta – haemolytic streptococci) infection is the primary bacterial cause of acute pharyngitis, accounting for approximately 5 to 15% of sore throat cases in adults and 20 to 30% in children.The standard medical approach to acute pharyngitis often involves the antibiotics for bacterial infection and relieve symptoms. Concerns about antibiotic resistance have arisen due to the excessive use of antibiotics, prompting the search for alternative treatment methods.The current research is centered on managing acute pharyngitis through the use of homoeopathic medicines, employing Boenninghausen’s method to construct the totality. The study is justified by the need to expand the evidence base for Homoeopathic treatment in this common medical condition. By examining the symptoms and individualized Homoeopathic remedies, the study aims to contribute to improved patient care in the management of acute pharyngitis. Improvement of the symptoms is assessed using Modified Naranjo Criteria for Homoeopathy clinical assessment tool. |