| CTRI Number |
CTRI/2024/05/066590 [Registered on: 01/05/2024] Trial Registered Prospectively |
| Last Modified On: |
30/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Clinical Trial Based On Exciting and Maintaining Causes In Management Of Tonsillitis By Homoeopathy |
|
Scientific Title of Study
|
Clinical Study On The Utility Of Individualised Homoeopathic Medicines Based On Exciting And Fundamental Causes In Management Of Tonsillitis - A Prospective Open Arm Interventional Study |
| Trial Acronym |
MOTH |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Himalaya Sahu |
| Designation |
Junior Resident MD Scholar |
| Affiliation |
State National Homoeopathic Medical College and Hospital,Lucknow |
| Address |
Department of Organon of Medicine & Homoeopathic Philosophy
State National Homoeopathic Medical College and hospital Viraj khand 1 Gomti nagar Lucknow UP
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
8896376576 |
| Fax |
|
| Email |
hims1690@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Archna Kumari |
| Designation |
Reader |
| Affiliation |
State National Homoeopathic Medical College and Hospital |
| Address |
Department of Organon of Medicine,State National Homoeopathic Medical College and Hospital Viraj khand 1 Gomti nagar Lucknow
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
9450522295 |
| Fax |
|
| Email |
archna505@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Archna Kumari |
| Designation |
Reader |
| Affiliation |
State National Homoeopathic Medical College and Hospital |
| Address |
Department of Organon Of Medicine,State National Homoeopathic Medical College and Hospital Viraj khand 1 Gomti nagar Lucknow
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
9450522295 |
| Fax |
|
| Email |
archna505@gmail.com |
|
|
Source of Monetary or Material Support
|
| State National Homoeopathic Medical College and Hospital Lucknow ,U.P. ,India-226010 |
|
|
Primary Sponsor
|
| Name |
Himalaya Sahu |
| Address |
Department of Organon of Medicine & Homoeopathic Philosophy ,
State National Homoeopathic Medical College and Hospital Lucknow U.P.,India-226010 |
| 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 Himalaya Sahu |
State National Homoeopathic Medical College and Hospital |
OPD ,State National Homoeopathic Medical College and Hospital Viraj khand 1 Gomti nagar Lucknow
Lucknow
UTTAR PRADESH |
8896376576
hims1690@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J350||Chronic tonsillitis and adenoiditis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized Homoeopathic medicine |
Intervention is planned as administering individualized homoeopathic medicine to a group of 30 patients suffering from Tonsillitis after detailed case taking and repertorization.Individualized homoeopathic medicine will be given in varying potencies of centesimal scale depending upon the susceptibility of the patient. Each dose shall consist of 4-5 globules of cane sugar medicated with single medicine(preserved in 90%v/v ethanol) to be taken orally on an empty stomach. Dosage and repetition will depend upon the individual requirement of the cases. |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient with age group 05 to 50 of both sexes having tonsillitis
2.Presenting with clinical signs and symptoms of chronic tonsillitis – presence of any symptoms: hyperaemia of anterior and posterior palatine arches, enlarged submandibular lymph nodes, halitosis, chronic sore throat, foreign body sensation or a history of expelling foul-tasting and foul smelling cheesy lumps.
3.Patient who are newly diagnosed with clinical acute tonsillitis.
4.Patients who can give consent informed and comply with study procedure |
|
| ExclusionCriteria |
| Details |
1. Patient with complications like Quinsy, Septic focus, Septicemia, Laryngeal oedema, Pharyngeal or Retropharyngeal abscess.
2. Diagnosed cases of Adenoids, Obstructive sleep apnea and Acute rheumatic fever.
3. Patient who require medical emergency intervention and systemic disease with intervention.
4. Presence of neurological or psychiatric diseases affecting quality of life.
5. Cases already undergoing homeopathic treatment for any chronic diseases.
6. Pregnant, puerperial and lactating women.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Friedman Grading Scale For Tonsils |
Improvement in the Friedman Grading Scale For Tonsils at day 1 and again after 15 day upto 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Visual analogue scale based on severity score |
Day 0,1,2,3,4,5,6 and7 |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
11/05/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
There is possibility to control and treat the tonsillitis with the help of sound knowledge of organon of medicine, materia medica and repertory because homoeopathy believes in the individual as whole not in disease .Our literature is full of information about clinical condition and related information . In clinical practice most of time we use to prefer constitutional remedy to control tonsillitis and most of time it works wonder. Only classical approach is not fit for these cases. These cases required several remedies based on totality on exciting and fundamental causes.
Our study is used to know the efficacy of Individualized Homoeopathic medicine in treating the acute and chronic cases of tonsillitis and to know the causes behind them. |