| CTRI Number |
CTRI/2025/01/079544 [Registered on: 27/01/2025] Trial Registered Prospectively |
| Last Modified On: |
28/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Other |
|
Public Title of Study
|
Treatment of acute tonsillitis by homoeopathic medicine of their peculiarities in paediatric age group |
|
Scientific Title of Study
|
Efficacy of Individualized Homoeopathic Medicines in the Treatment of Acute Tonsillitis in Paediatric Age Group An Experimental One Group Pre-Test Post-Test 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. Neerja Dugtal |
| Designation |
Associate Professor |
| Affiliation |
Uttarakhand Ayurved University, Dehradun |
| Address |
Assoc Professor, Dept of Obstetrics & Gynaecology, Chandola Homoeopathic Medical College & Hospital, Kichha Rd, Rudrapur, Uttarakhand
Udham Singh Nagar
UTTARANCHAL
263148
India |
| Phone |
7668259807 |
| Fax |
05944-280039 |
| Email |
neerjadugtal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prasoon Choudhary |
| Designation |
Professor & HOD, Dept. of Paediatrics |
| Affiliation |
Homoeopathy University |
| Address |
Homoeopathy University, 10, 11 & 12, Ward No 36, Saipura, Sanganer
Jaipur
RAJASTHAN
302029
India |
| Phone |
9414718100 |
| Fax |
|
| Email |
drprasoonchoudhary@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Neerja Dugtal |
| Designation |
Associate Professor |
| Affiliation |
Uttarakhand Ayurved University, Dehradun |
| Address |
Assoc Professor, Dept of Obstetrics & Gynaecology, Chandola Homoeopathic Medical College & Hospital, Kichha Rd, Rudrapur, Uttarakhand
Udham Singh Nagar
UTTARANCHAL
263148
India |
| Phone |
7668259807 |
| Fax |
05944-280039 |
| Email |
neerjadugtal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Chandola Homoeopathic Medical College and Hospital, Kichha Rd, P.O. Lalpur, Dist. U.S. Nagar, Uttarakhand - 263148 |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Other [Nil] |
|
|
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 Neerja Dugtal |
Chandola Homoeopathic Medical College & Hospital |
Paediatrics OPD & IPD, Chandola Homoeopathic Medical College & Hospital, Kichha Rd, Rudrapur, Uttarakhand 263148
Udham Singh Nagar
UTTARANCHAL |
7668259807
neerjadugtal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Homoeopathy University Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J039||Acute tonsillitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Belladonna
Mercurius solubilis
Hepar sulphuris
Phytolacca
Baryta carb
Calc carb
Apis
Arsenic
Lachesis |
30 200 1M orally OD BD TDS according to susceptibility of patient for 3 months.Total enrollment period is 6 months. Prospective study will be conducted for 9 months. |
| Intervention |
Thuja Sabina Sulphur Calc carb Baryta carb Thuja Phytolaccin Sabina Bacillinum Hepar sulph Silicea Guaicum |
30 200 1M orally OD BD TDS according to susceptibility of patient. Prospective study will be conducted for 9 months. Enrollment period will be 6 months. We will monitor each patients progress for minimum 3 months, noting improvements or worsening of symptoms, response to treatment and any development of complications. Patients will be scheduled for follow up visits to assess their response to treatment, monitor for any complications and determine if discontinuation criteria have been met. Patients will be followed up every week in first month then fortnightly in second third month. Additionally, receiver operating characteristic (ROC) curve analysis can be performed to evaluate the overall performance of the criteria across different cutoff points. |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
Patient within a specific age range 2 to 16 years old
Clinically diagnosed CA03 acute tonsillitis by ICD 11
Patient presenting with acute symptoms of tonsillitis within the past 48 hrs
Patient with minimum score on the Centor Criteria scale
Patients without underlying chronic diseases or conditions that might complicate the study or affect the outcome
Residing in nearby communities
Male and female both gender
Patients and their guardians willing to comply with the study protocol, including follow-up visits and medication compliance
Informed consent from the parent or legal guardian of the paediatric patient to participate in the study |
|
| ExclusionCriteria |
| Details |
Patients with chronic or recurrent tonsillitis
Patients who have undergone recent tonsillectomy, as this would affect the presentation and management of tonsillitis
Patients with compromised immune systems due to diseases (e.g., HIV/AIDS) or medications (e.g., chemotherapy)
Patients with known allergies or sensitivities to the medications being used in the study
Patients with severe coexisting illnesses or conditions that could interfere with the study or their ability to comply with the treatment regimen
Patients who have participated in a similar study or received the same treatment within a certain timeframe to avoid duplication of data
Patients who are unlikely to comply with the study protocol, such as missing follow-up appointments or not taking medications as prescribed |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assess the efficacy of individualised homoeopathic medicines in the treatment of acute tonsillitis in paediatric age group. |
Assess the efficacy of individualised homoeopathic medicines in the treatment of acute tonsillitis in paediatric age group by using the Centor Criteria scale every month. Each case will be followed up for 3 months. Study time period will be 9 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assess the efficacy of individualised homoeopathic medicines in reducing the severity of symptoms in acute tonsillitis in paediatric age group. |
Assess the efficacy of individualised homoeopathic medicines in reducing the severity of symptoms in acute tonsillitis in paediatric age group by using the Centor Criteria scale every month. Each case will be followed up for 3 months. Study time period will be 9 months. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
01/02/2025 |
| 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
|
Prospective study will be conducted for 9 months. We will assess patients presenting with acute tonsillitis, including history taking and physical examination to determine symptom severity, duration, and any complications. Enrollment period will be 6 months. We will monitor each patients’ progress for minimum 3 months, noting improvements or worsening of symptoms, response to treatment and any development of complications. Patients will be scheduled for follow up visits to assess their response to treatment, monitor for any complications and determine if discontinuation criteria have been met. Patients will be followed up every week in first month then fortnightly in second third month. Additionally, receiver operating characteristic (ROC) curve analysis can be performed to evaluate the overall performance of the criteria across different cutoff points. |