| CTRI Number |
CTRI/2024/09/073697 [Registered on: 10/09/2024] Trial Registered Prospectively |
| Last Modified On: |
03/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effectiveness of homoeopathic medicine Tuberculinum bovinum in reducing the nasal obstruction of adenoid hypertrophy in children |
|
Scientific Title of Study
|
Effect of Tuberculinum bovinum on nasal airway obstruction of Adenoid hypertrophy: A single-arm quasi-experimental study |
| 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 Fathima N M |
| Designation |
Post graduate student |
| Affiliation |
Government Homoeopathic Medical College Kozhikode |
| Address |
Department of Materia Medica
Government Homoeopathic Medical collage karaparamba kozhikode
Kozhikode
KERALA
673010
India |
| Phone |
9495530665 |
| Fax |
|
| Email |
fathimaalinm@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr ARUNPRASAD |
| Designation |
GUIDE |
| Affiliation |
Government Homoeopathic Medical College Kozhikode |
| Address |
Department of Materia Medica
Government Homoeopathic Medical collage karaparamba kozhikode
Kozhikode
KERALA
673010
India |
| Phone |
9846040847 |
| Fax |
|
| Email |
appoo.ap@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Fathima N M |
| Designation |
Post graduate student |
| Affiliation |
Government Homoeopathic Medical College Kozhikode |
| Address |
Department of Materia Medica
Government Homoeopathic Medical collage karaparamba kozhikode
Kozhikode
KERALA
673010
India |
| Phone |
9495530665 |
| Fax |
|
| Email |
fathimaalinm@gmail.com |
|
|
Source of Monetary or Material Support
|
| Goverment Homoeopathic Medical collage karaparamba kozhikode |
|
|
Primary Sponsor
|
| Name |
Dr Fathima N M |
| Address |
Post graduate student
Department of Materia Medica
Government Homoeopathic Medical collage karaparamba kozhikode |
| 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 Fathima N M |
Government Homoeopathic Medical collage kozhikode |
research op
ground floor,old building,Government Homoeopathic Medical collage kozhikode
Kozhikode
KERALA |
9495530665
fathimaalinm@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Government Homoeopathic Medical College Kozhikode |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J352||Hypertrophy of adenoids, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
Tuberculinum bovinum |
Homoeopathic Medicine Tuberculinum bovinum above
30 th potency mentioned in HPI
will be administered orally
according to the principles of
Homoeopathy for 12 weeks. |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion criteria
1. Patients satisfying the case definition.
2. Age group between 03 and 10 years of both sexes. |
|
| ExclusionCriteria |
| Details |
Exclusion criteria
1. Patients with underlying immune deficiencies, neoplasia
2. Children with congenital malformations of the face, a deviated nasal septum, nasal
polyposis, and tumours
3. Children with bleeding disorders
4. Past history of adenoid surgery
5. Patients with severe systemic illnesses. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To determine the changes in nasal obstructive symptoms of hypertrophied adenoid in
children after 12 weeks of treatment with the homoeopathic medicine Tuberculinum
bovinum by assessing the clinical score for adenoid hypertrophy. |
Compared at baseline, 4 weeks, 8 weeks, and
12 weeks of treatment. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To determine whether there is a reduction in adenoid size after administration of
Tuberculinum bovinum in children with adenoid hypertrophy using lateral X-ray
skull. |
At baseline & after 12 weeks |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
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)
|
17/09/2024 |
| 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 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
|
Adenoid hypertrophy is a common disorder in children and can result in symptoms like mouth breathing, nasal discharge, snoring, sleep apnea, voice changes, and blockage of the Eustachian tube. Recurrent otitis media, as well as long-term nasal obstruction, can result in pulmonary hypertension and corpulmonale. As an effective, non-operative method, Homoeopathy offers good scope in the treatment of hypertrophied adenoids. A study by Poonam et al. suggests that homeopathic medicines may play a beneficial role in the management of symptomatic adenotonsillar hypertrophy in children. Tuberculinum bovinum is an excellent remedy in the treatment of adenoid hypertrophy in Homoeopathy. Dr. J.T. Kent, in his lesser writings, said, „I have cured probably 100 cases of adenoids with Tuberculinum alone, so that the children breathe 4 through the nose and close the mouth‟. |