| CTRI Number |
CTRI/2025/04/083854 [Registered on: 02/04/2025] Trial Registered Prospectively |
| Last Modified On: |
19/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
TO STUDY THE ROLE OF MIASMS IN CASES OF CHRONIC TONSILLITIS AND ITS HOMOEOPATHIC MANAGEMENT |
|
Scientific Title of Study
|
MIASMATIC INTERPREATATION OF CHRONIC TONSILITIS AND IT’S HOMOEOPATHIC MANAGEMENT |
| 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 Rashmi Vaghela |
| Designation |
PG Scholer |
| Affiliation |
Rajkot Homoeopathic Medical College |
| Address |
Department of Organon of Medicine and Homoeopathic Philosophy, Rajkot Homoeopathic
Medical College, behind jainath complex, makkam chowk, Rajkot
Rajkot GUJARAT 360002 India |
| Phone |
9173179249 |
| Fax |
|
| Email |
rashamivaghela95@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Mital N Kacha |
| Designation |
Assistant Professor |
| Affiliation |
Rajkot Homoeopathic Medical College |
| Address |
Department of Organon of Medicine and Homoeopathic Philosophy, Rajkot Homoeopathic
Medical College, behind jainath complex, makkam chowk, Rajkot
Rajkot GUJARAT 360002 India |
| Phone |
9099144019 |
| Fax |
|
| Email |
dr.mitalkacha@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Rashmi Vaghela |
| Designation |
PG Scholer |
| Affiliation |
Rajkot Homoeopathic Medical College |
| Address |
Department of Organon of Medicine and Homoeopathic Philosophy, Rajkot Homoeopathic
Medical College, behind jainath complex, makkam chowk, Rajkot
Rajkot GUJARAT 360002 India |
| Phone |
9173179249 |
| Fax |
|
| Email |
rashamivaghela95@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rajkot Homoeopathic Medical Collage,Parul university |
|
|
Primary Sponsor
|
| Name |
Rajkot Homoeopathic Medical Collage,Parul university |
| Address |
Department of Organon of Medicine and Homoeopathic Philosophy, Rajkot Homoeopathic
Medical College, behind jainath complex, makkam chowk, Rajkot Gujrat 360002 India |
| 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 Rashmi Vaghela |
RAJKOT HOMOEOPATHIC MEDICAL COLLAG |
Department of Organon of Medicine and Homoeopathic Philosophy,Rajkot Homoeopathic Medical College,behind Jainath Complex, Makkam chowk, Rajkot, Gujrat 360002 India Rajkot GUJARAT |
9173179249
rashamivaghela95@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, Gujara |
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 |
Individualized homoeopathic medicine selected on basis of underlying miasm by repertorial aspect and mangement of case.
Mode of Administration: Oral(sublingual) Selection of
potency, dose and repetition:
individualised medicine will be presecribed in 30, 200, 1 M potency. selection of dosage,
potency and repitation will be according to susceptibility of patient and principles of
organon of medicine |
| Comparator Agent |
not applicable |
not applicable |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
All socio-economic class view considered. |
|
| ExclusionCriteria |
| Details |
Age below 5 and more than 45
Pregnant and lactating women.
Chronic tonsillitis cases with major complications
Patients on prolonged immunosuppression and antibiotic therapy.
Cases with irregular follow ups & patients who had not followed personal hygiene advises and auxiliary measures as advised by the physician.
Cases of chronic disease with irreversible pathological changes.
|
|
|
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 |
it will be assessed every 2 weeks and will be tried to achieve maximum by 9 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Significant Improvement- sense of well being with no complaints or relapse of the
symptoms.
Moderate Improvement- patient relieved from presenting complaints in frequency & intensity.
Status quo- when there is neither increase nor decrease in the intensity of symptoms.
|
This may be also achieved within the time frame of primary outcome that is within 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 2 |
|
Date of First Enrollment (India)
|
05/04/2025 |
| 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
Modification(s)
|
Recurrent tonsillitis is described as when an individual suffers from several attacks of tonsillitis per year. Chronic and recurrent tonsillitis both cause repeated occurrences of inflamed tonsils which have a significant impact on a patient’s quality of life. Numerous children suffer from recurrent tonsillitis and sore throats, and these illnesses become part of their life. Antimicrobials can provide temporary relief, but in many cases tonsilitis recurs. The cause of such recurrent infections have been identified as microorganisms which often create biofilms and a repository of infection in the wet and warm folds of the tonsils. Chronic inflammatory changes in the tonsils are usually the result of recurrent acute infections treated inadequately. Recurrent infections lead to development if minute abscesses within the lymphoid follicles. These become walled off by fibrous tissue and surrounded by inflammatory cells. Homoeopathy is a system of medicine that has scope in chronic or recurrent tonsilitis because allopathy has nothing to offer other than tonsillectomy. Treatment option of chronic or recurrent tonsilitis include the conservative treatment consists of attention to general health, diet, treatment of coexistent infection of teeth, nose & sinuses. Tonsillectomy is indicated when tonsils interfere with speech, deglutination and respiration or cause recurrent attacks. As Hahnemann described it, a miasm defined as the fundamental cause of an erroneous or diseased state of the. Chronic conditions are caused by chronic miasms, just as acute conditions are caused by acute miasms. Miasms cause a complete dynamic and physical change to the interior of the whole man...his whole being is altered. It is only after this complete change has occurred that symptoms of the disease change have occurred that the disease or illness are demonstrated. Chronic diseases slowly progress and symptoms result over the course of a lifetime, due to an inadequate constitutional response to a miasm. With respect to acute disease or illness,there is a rapid onset of symptoms progressing towards a crisis which ends in recovery or death without treatment. For example, cancer is typically a chronic disease that progresses slowly over the years whereas the flu is an acute disease that progress swiftly over a few days. In both conditions the entire body has to be compromised or changed by the miasm before the symptoms are demonstrated by the patients. So, in case chronic tonsilitis that is result from recurrent attack of acute tonsilitis or infection of the tonsils that lasts longer than a week or two, there is underlying chronic miasms is present. So, in homoeopathy in such chronic conditions or disease or recurrent disease on the basis of underlying prominent miasm of patient we give the simillimum & anti-miasmatic medicines to the patient. By this way we can treat the person as a whole & remove the disease from its root. We can also prevent the disease by preservative measures. In case of chronic diseases we can also prevent surgical measures or recurrency by giving proper homoeopathic medicine on basis of miasms. So, our purpose of study of miasmatic interpretation of chronic tonsillitis is to prevent tonsillectomy & to prevent recurrence of tonsillitis and to remove the disease from its root. Homoeopathic management of chronic tonsillitis include both preventive and medicinal view. Because prevention is always better than cure. We can prevent the recurrent tonsillitis by good oral hygiene and other ways. And by giving simimllimum homoeopathic medicines also cure the chronic tonsillitis from root without tonsillectomy and no recurrence occur. v RESEARCH QUESTION: - How is miasms useful
in the management of Chronic Tonsillitis or Recurrent Tonsillitis. HYPOTHESIS: - 1.
Null Hypothesis — There will be no improvement after prescribing Homoeopathic
Medicine in case of chronic tonsillitis. 
2.
Alternate Hypothesis — There will be significant improvement in symptoms after
prescribing Homoeopathic medicine in case of chronic tonsillitis.
|