| CTRI Number |
CTRI/2024/11/076861 [Registered on: 18/11/2024] Trial Registered Prospectively |
| Last Modified On: |
16/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study on underlying causes in cases of Sore throat in children. |
|
Scientific Title of Study
|
An interventional Study To Estimate The Miasmatic Influence In Cases of Acute Pharyngitis Among paediatrics Age Group |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
G N Sai Satish |
| Designation |
PG SCHOLAR |
| Affiliation |
Bharati Vidyapeeth deemed to be University, Homoeopathic Medical College and Hospital |
| Address |
Bharati Vidyapeeth Deemed to be University
Homoeopathic Medical College and Homoeopathic Hospital
Dept. of Post Graduate and Research Centre
Pune Bangalore Highway
Pune 411043
Pune
MAHARASHTRA
411043
India |
| Phone |
7396185348 |
| Fax |
|
| Email |
saisateesh14@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vinodini V Patil |
| Designation |
Associate Professor Dept of Organon of Medicine |
| Affiliation |
Bharati Vidyapeeth deemed to be University, Homoeopathic Medical College and Hospital |
| Address |
Bharati Vidyapeeth Deemed to be University
Homoeopathic Medical College and Homoeopathic Hospital
Dept. of Post Graduate and Research Centre
Pune Bangalore Highway
Pune 411043
Pune
MAHARASHTRA
411043
India |
| Phone |
9890127840 |
| Fax |
|
| Email |
vinodini.patil@bharatividyapeeth.edu |
|
Details of Contact Person
Public Query
|
| Name |
G N Sai Satish |
| Designation |
PG SCHOLAR |
| Affiliation |
Bharati Vidyapeeth deemed to be University, Homoeopathic Medical College and Hospital |
| Address |
Bharati Vidyapeeth Deemed to be University
Homoeopathic Medical College and Homoeopathic Hospital
Dept. of Post Graduate and Research Centre
Pune Bangalore Highway
Pune 411043
Pune
MAHARASHTRA
411043
India |
| Phone |
7396185348 |
| Fax |
|
| Email |
saisateesh14@gmail.com |
|
|
Source of Monetary or Material Support
|
| BVDU Homoeopathic Medical college ,Dept of Post Graduate and Research Centre.
Pune-Satara road , Katraj
Dhankawadi
Pune
India 411043 |
|
|
Primary Sponsor
|
| Name |
G N SAI SATISH |
| Address |
Bharati Vidyapeeth Deemed to be University
Homoeopathic Medical College and Homoeopathic Hospital
Dept. of Post Graduate and Research Centre
Pune Bangalore Highway
Pune 411043 |
| Type of Sponsor |
Other [Self] |
|
|
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 G N SAI SATISH |
BVDUHMC DEPT OF PG And Research Centre Dept Of Organon of Medicine with Homoeopathic Philosophy |
Bharati Vidyapeeth Deemed to be University
Homoeopathic Medical College and Homoeopathic Hospital
Dept. of Post Graduate and Research Centre
Pune Bangalore Highway
Pune 411043
Pune
MAHARASHTRA |
7396185348
saisateesh14@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Bharati Vidyapeeth (DTU) HMC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J02||Acute pharyngitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Potentised homoeopathic medicine |
Potentised homoeopathic medicine in the form of pills or powder on basis of symptom similarity and patients susceptibility in various potencies in each individual case.
Route of administration: oral
study duration 1 year |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
Patients diagnosed with acute pharyngitis.
Patients of age 1-14 years.
Patients of both sex.
Patients complying for regular follow up.
Patients opting for homoeopathic medicines. |
|
| ExclusionCriteria |
| Details |
Patients who have not filled consent form.
Patients who are having other systemic illness.
Patients with lower respiratory disease.
Patients with complicated stage. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the miasmatic predominance in acute pharyngitis . |
The follow ups will be taken every 2 days after giving a suitable homoeopathic medicine for a duration of 12 days. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To estimate the effectiveness of homeopathic medicines in cases of acute pharyngitis. |
The follow ups will be taken every 2 days after giving a suitable homoeopathic medicine for a duration of 12 days. |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
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)
|
18/11/2024 |
| 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="1"
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
|
This study is single blind non randomised control trail to see the results of the predominant miasmatic background in cases of acute pharyngitis among paediatrics age group .The duration will be of one year and will be done on 34 patients at Bharati Vidyapeeth medical foundation Homoeopathic Hospital OPD,IPD and various rural and urban camps conducted by hospital , Katraj and periphery OPD. The primary outcome will be assessed using the follow up to see the miasmatic predominance in cases of acute pharyngitis among paediatrics age group . The secondary outcome is to estimate the effectiveness of homoeopathic medicines in cases of acute pharyngitis.
|