| CTRI Number |
CTRI/2025/09/094147 [Registered on: 03/09/2025] Trial Registered Prospectively |
| Last Modified On: |
03/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Evaluating effective management of snoring in type 2 diabetic patients through homoeopathy. |
|
Scientific Title of Study
|
To Evaluate the Effectiveness of Individualized Homeopathic Medicines vs. Placebo in the Management of Obstructive Sleep Apnea in Patients with Type 2 Diabetes Mellitus Undergoing Conventional Treatment. |
| 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 Neeraj Gupta |
| Designation |
Professor and Principal |
| Affiliation |
SHMC and Hosp |
| Address |
Room No 10 Ground floor Dr B R Sur Homoeopathic Medical College Hospital and Research Centre Nanakpura Moti Bagh New Delhi 110021
Room No 10 Ground floorDr B R Sur Homoeopathic Medical College Hospital and Research Centre Nanakpura Moti Bagh New Delhi 110021
New Delhi
DELHI
110021
India |
| Phone |
09212013664 |
| Fax |
|
| Email |
drneerajgupta2003@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neeraj Gupta |
| Designation |
Professor and Principal |
| Affiliation |
SHMC and Hosp |
| Address |
Room No 10 Ground floor Dr B R Sur Homoeopathic Medical College Hospital and Research Centre Nanakpura Moti Bagh New Delhi 110021
Room No 10 Ground floor Dr B R Sur Homoeopathic Medical College Hospital and Research Centre Nanakpura Moti Bagh New Delhi 110021
New Delhi
DELHI
110021
India |
| Phone |
09212013664 |
| Fax |
|
| Email |
drneerajgupta2003@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neeraj Gupta |
| Designation |
Professor and Principal |
| Affiliation |
SHMC and Hosp |
| Address |
Room No 10 Ground floor Dr B R Sur Homoeopathic Medical College Hospital and Research Centre Nanakpura Moti Bagh New Delhi 110021
Room No 10 Ground floor Dr B R Sur Homoeopathic Medical College Hospital and Research Centre Nanakpura Moti Bagh New Delhi 110021
New Delhi
DELHI
110021
India |
| Phone |
09212013664 |
| Fax |
|
| Email |
drneerajgupta2003@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Dr B R Sur Homoeopathic Medical College Hospital and Research Centre Nanakpura Moti Bagh New Delhi 110021 |
|
|
Primary Sponsor
|
| Name |
Dr Neeraj Gupta |
| Address |
Dr B R Sur Homoeopathic Medical College Hospital and Research Centre Nanakpura Moti Bagh New Delhi 110021 |
| 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 Neeraj Gupta |
Dr B R Sur Homoeopathic Medical College Hospital and Research Centre |
Dr B R Sur Homoeopathic Medical College Hospital and Research Centre Nanakpura Moti Bagh New Delhi 110021
Dr B R Sur Homoeopathic Medical College Hospital and Research Centre Nanakpura Moti Bagh New Delhi 110021
New Delhi
DELHI |
09212013664
drneerajgupta2003@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethics Committee, Dr. B R Sur, homoeopathic Medical College, Hospital, Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E089||Diabetes mellitus due to underlying condition without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized Homeopathic Medicines |
After case taking and analysis individualized homeopathic medicine will be given for two weeks and followed up thereafter six months
Duration Six Month |
| Comparator Agent |
Placebo |
After case taking and analysis placebo will be given for two weeks and followed up thereafter six months
Duration Six Month |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients having Clinical signs and symptoms suggestive of Obstructive Sleep Apnea OSA such as loud snoring observed apneas or excessive daytime sleepiness in diagnosed cases of Type 2 DM under conventional treatment
Patients Clinically diagnosed with obstructive sleep apnea as confirmed by an Apnea Hypopnea Index within the range indicative of mild to moderate OSA
Patients of age group 30 years to 70 years
Both male and female patients will be included
Overweight and obese individuals defined as having a Body Mass Index of 25kg per meter square or above indicating increased risk of OSA
|
|
| ExclusionCriteria |
| Details |
TYPE 2 DM Patients suffering from any life-threatening illness and its complications.
Individuals with Type 2 Diabetes Mellitus currently undergoing insulin therapy.
Use of continuous positive airway pressure (CPAP) therapy.
Patients who are terminally ill, under immunosuppressive treatment.
Patients of malignancy
Extremely sick patients
Any known heart conditions, CHF, MI etc.
Serious mental illness & seizure disorder.
Patients unable to comply with the study protocol (including psychiatric diseases).
Lactating mothers and pregnant ladies are excluded.
Patients having major airway obstruction needing surgical intervention.
Patient not willing to give consent for participating in this study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Polysomnography finding |
1st will be done at the baseline
2nd will be done at third month 3rd will be done at sixth month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Pittsburgh Sleep Quality Index
Sleep Apnea Quality of Life Index Epworth Sleepiness Scale Improvement in diabetic symptoms & glycemic control
|
1st will be done at the baseline
2nd will be done at third month 3rd will be done at sixth 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)
|
15/09/2025 |
| 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 - NO
|
|
Brief Summary
|
The study is to evaluate the effectiveness of individualized homeopathic medicines versus placebo in the management of obstructive sleep apnea in patients with type two diabetes mellitus undergoing conventional treatment. It is a randomized controlled trial which includes thirty diagnosed cases of type two diabetes mellitus undergoing conventional treatment presenting with signs and symptoms of obstructive sleep apnea like snoring based on the inclusion criteria will be selected and divided into two groups group A individualized homeopathic medicine under ongoing conventional treatment group B placebo under ongoing conventional treatment a well selected homoeopathic remedy on the basis of case taking analysis evaluation totality of symptoms and repertorization as per the homoeopathic principles will be given to group A. subjects from group B will be given placebo the potency will be chosen as per the requirement of the case and homoeopathic principles. The outcome will be measured through Pittsburgh Sleep Quality Index Sleep Apnea Quality of Life Index Epworth Sleepiness Scale Polysomnography finding |