| CTRI Number |
CTRI/2025/10/095885 [Registered on: 10/10/2025] Trial Registered Prospectively |
| Last Modified On: |
10/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Homoeopathy for Nasal obstruction in children and Its Effects on Sleep Quality |
|
Scientific Title of Study
|
A Clinical Study On The Role Of Homoeopathy In Treating Nasal Obstruction And Its Impact On Quality Of Sleep Among Paediatric 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 |
Dr HAJEERA A |
| Designation |
Junior Resident, Department of Paediatrics |
| Affiliation |
White Memorial Homoeo Medical College |
| Address |
Department of Homoeopathic Paediatrics, White Memorial Homoeo Medical College, Attoor, Veeyanoor PO
Kanniyakumari
TAMIL NADU
629177
India |
| Phone |
9500250050 |
| Fax |
|
| Email |
hajeedr72@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr ABHIJITH RANJAN S |
| Designation |
Associate Professor, Department of Paediatrics |
| Affiliation |
White Memorial Homoeo Medical College |
| Address |
Department of Homoeopathic Paediatrics, White Memorial Homoeo Medical College, Attoor, Veeyanoor PO
Kanniyakumari
TAMIL NADU
629177
India |
| Phone |
9809012398 |
| Fax |
|
| Email |
abhijithranjans@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr ABHIJITH RANJAN S |
| Designation |
Associate Professor, Department of Paediatrics |
| Affiliation |
White Memorial Homoeo Medical College |
| Address |
Department of Homoeopathic Paediatrics, White Memorial Homoeo Medical College, Attoor, Veeyanoor PO
Kanniyakumari
TAMIL NADU
629177
India |
| Phone |
9809012398 |
| Fax |
|
| Email |
abhijithranjans@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Homoeopathic Paediatrics, White Memorial Homoeo Medical College, Attoor, Veeyanoor PO, Kanniyakumari, Tamilnadu, India Pin: 629177 |
|
|
Primary Sponsor
|
| Name |
WHITE MEMORIAL HOMOEO MEDICAL COLLEGE AND HOSPITAL |
| Address |
ATTOOR, VEEYANOOR POST, KANNIYAKUMARI DISTRICT. TAMILNADU - 629177 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 HAJEERA A |
White Memorial Homoeo Medical College and Hospital |
Medical College and Hospital Department of Paediatrics, White Memorial Homoeo Medical College and Hospital, Attoor, Veeyanoor PO, Kanniyakumari, Tamilnadu, India Pin 629177
Kanniyakumari
TAMIL NADU
Kanniyakumari
TAMIL NADU |
9500250050
hajeedr72@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| WHITE MEMORIAL HOMOEO MEDICAL COLLEGE AND HOSPITAL ETHICS COMMITTEE WMHMCH-EC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J348||Other specified disorders of noseand nasal sinuses, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized Homoeopathic medicine |
A single homoeopathic medicine will be selected through proper Repertorization and Materia Medica and prescribed with suitable potency according to the patients susceptibility based on the Homoeopathic principles. The intervention will be administered with the intervals of 15 days once after follow ups. |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
School going children of age 5-14 years
Children of both sexes.
The patients who are having nasal obstruction (NOSE), with sleep disturbance qualifying more than 0.33 Paediatric Sleep Quesstionare (PSQ) score |
|
| ExclusionCriteria |
| Details |
Patients below 5years and above 14 years of age.
Patients with other systemic illnesses or complications.
Patients suspected or confirmed structural abnormalities.
Patients with intellectual disability or global developmental delay. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pre and post treatment assessment will be based on PAEDIATRIC SLEEP QUESTIONIARE (PSQ) tool.
10 – 30% = Mild improvement
35 – 70% = Moderate improvement
more than 75% = Marked improvement
Monthly follow up with improvement in sleep quality |
6 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The improvement in the quality of sleep among nasal obstruction in children is considered to indicate that Individualized Homoeopathic medicines are effective. |
6 month |
|
|
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)
|
01/12/2025 |
| 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="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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [hajeedr72@gmail.com].
- For how long will this data be available start date provided 30-12-2026 and end date provided 30-12-2031?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
AIM: To study the effectiveness of individualized homoeopathic medicine in managing sleep disturbance due to nasal obstructions and improving sleep quality of children.
BACKGROUND AND JUSTIFICATION: Nasal obstruction is thought to be a major cause of sleep impairment. Typical sleep-related problems seen with nasal obstruction include snoring, sleep-disordered breathing and sleep apnea. The impact of nasal obstruction on quality of life is well studied, however its effects on sleep have been less well studied. This study aims to investigate sleep disturbances in paediatric patients with nasal obstructions using paediatric sleep questionnaires.
HYPOTHESIS: NULL HYPOTHESIS: Homoeopathic medicine is not effective in the management of sleep disturbance induced by Nasal obstruction. ALTERNATIVE HYPOTHESIS: Homoeopathic medicine is effective in the management of sleep disturbance induced by Nasal obstruction.
METHODOLOGY A sample of 30 cases will be selected based on purposive sampling. With the patient consent, detailed case taking will be done. The patient will be assessed at baseline with the PAEDIATRIC SLEEP QUESSTIONIARE tool as pre assessment. After case taking, the totality of symptoms will be obtained through the analysis and evaluation of symptoms. With the help of proper repertorization and Homoeopathic Materia Medica, final selection of remedy will be done by Individualization. Then the Individualized Homoeopathic medicine will be prescribed with the proper dose, potency, and repetition of medicines according to the Homoeopathic principles. Follow up will be done 2 weeks once and every change in the quality of sleep will be assessed monthly once using on PAEDIATRIC SLEEP QUESSTIONIARE tool as post assessment. |