| CTRI Number |
CTRI/2025/02/080047 [Registered on: 07/02/2025] Trial Registered Prospectively |
| Last Modified On: |
04/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Use of Homoeopathy in obstructive sleep apnea |
|
Scientific Title of Study
|
Role of homoeopathic medicines in risk modification of the patients with obstructive sleep apnea using kent’s repertory: a single arm pre and post clinical trial
|
| 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 Wajeeha Qureshi |
| Designation |
Post Graduate Trainee |
| Affiliation |
National institute of Homoeopathy |
| Address |
OPD No 10,Departmentof case taking and Repertory.
National institute of Homoeopathy, Block GE, Sector3 Bidhannagar, Salt Lake,700106, WEST BENGAL
North Twentyfour Parganas
WEST BENGAL
700106
India |
| Phone |
7489884636 |
| Fax |
|
| Email |
minshinkim4636@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Lokanath Behera |
| Designation |
Associate Professor |
| Affiliation |
National institute of Homoeopathy |
| Address |
OPD No 10, Repertory department
National institute of Homoeopathy, Block GE, Sector3 Bidhannagar, Salt Lake, kolkata 700106, WEST BENGAL
North Twentyfour Parganas
WEST BENGAL
700106
India |
| Phone |
9477747610 |
| Fax |
|
| Email |
LOKANATH.NIH@GOV.IN |
|
Details of Contact Person
Public Query
|
| Name |
Dr Lokanath Behera |
| Designation |
Associate Professor |
| Affiliation |
National institute of Homoeopathy |
| Address |
OPD No 10, Repertory department
National institute of Homoeopathy, Block GE, Sector3 Bidhannagar, Salt Lake, kolkata 700106, WEST BENGAL
North Twentyfour Parganas
WEST BENGAL
700106
India |
| Phone |
9477747610 |
| Fax |
|
| Email |
LOKANATH.NIH@GOV.IN |
|
|
Source of Monetary or Material Support
|
| National institute of Homoeopathy, Block GE, Sector3 Bidhannagar, Salt Lake,700106, WEST BENGAL |
|
|
Primary Sponsor
|
| Name |
national institute of homoeopathy |
| Address |
National institute of Homoeopathy, Block GE, Sector3 Bidhannagar, Salt Lake, kolkata 700106, WEST BENGAL |
| Type of Sponsor |
Government 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 Wajeeha Qureshi |
National institute of Homoeopathy |
National institute of Homoeopathy, Block GE, Sector3 Bidhannagar, Salt Lake, kolkata 700106, WEST BENGAL
North Twentyfour Parganas
WEST BENGAL |
7489884636
minshinkim4636@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| National institute of Homoeopathy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G473||Sleep apnea, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
Individualized Homoeopathic
medicine |
Indicated individualized homoeopathic medicine will be
prescribed after proper case taking and the repertorisation of the case using rubrics within kents repertory. Dose and frequency of the selected medicine will be given as per the susceptibility of the case. Follow up will be done monthly till 6 months from the baseline for each case. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
(1) patients willing to take part in the study and ready to give informed patient consent for the same.
(2).Patients who are able to either read, write or understand Hindi, English or Bengali.
(3).Patients suffering from obstructive sleep apnea with berlin questionnaire score more than or equal to one.
(4).Patients without any systemic disease or with known but controlled systemic diseases.
|
|
| ExclusionCriteria |
| Details |
1)Pregnant or lactating women.
2)Diagnosed cases of unstable mental or psychiatric illness or other systemic disease affecting quality of life.
3)Substance abuse and/or dependence.
4)Patient who are having malignant diseases/life threatening diseases or immune compromised state or any other diseases who needs surgical intervention.
5)Patients with uncontrolled systemic illness or any organ failure.
6) Currently receiving homoeopathic treatment for any chronic condition.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Berlin Questionnaire. |
Baseline and After 6Months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Sociodemographic Data |
After 6 months |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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)
|
17/02/2025 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Obstructive Sleep Apnea is a chronic disorder caused by repetitive collapse of the UA during
sleep. Episodes of complete (apnea’s) and partial (hypopneas) cessation of airflow can
lead to two main consequences: arousals from sleep and oxyhaemoglobin desaturations.
Apnea’s and hypopneas occur in all phases of sleep, but are more common in N1, N2 and
rapid eye movement (REM) sleep stages than in N3 sleep.1.Samples will be selected following preliminary and detailed screening using specified selection criteria. 2.Inclusion and exclusion criteria are strictly followed. 3.After consideration of dropout cases, a minimum 40 patients will be enrolled for the study. 4.Case-taking will be done as per the strict homoeopathic principle. 5.Baseline scoring will be taken using Berlin-Questionnaire 6.Analysis and evaluation of each case will be done. 7.Miasmatic analysis will be done. 8.Repertorization will be done in Synthesis Repertory. 9.Final selection of the remedy will be done after consultation with Materia Medica, 10.Potency, dose and repetition of the indicated remedies will be guided strictly as per homoeopathic principles. 11.General (non-medicinal) management including appropriate diet and regimen will be advised. 12.Subsequent prescriptions (follow-ups) will be generated according to relevant homoeopathic principles and will be recorded in follow-up sheets. 13.The baseline data will be compared with the data obtained after 6th months. 14.The score obtained by the patients will be compared and result will be analyzed as per appropriate statistical methods and interference will be done thereafter. |