| CTRI Number |
CTRI/2024/11/077383 [Registered on: 27/11/2024] Trial Registered Prospectively |
| Last Modified On: |
06/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role of Homoeopathic Medicines in the treatment of headache along with watery nose |
|
Scientific Title of Study
|
A Clinical Study to evaluate the Utility of Synthesis Repertory 9.1 Augmented Edition in the treatment of Chronic Rhinosinusitis |
| 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 Sivadharshini S |
| Designation |
Pg Scholar |
| Affiliation |
Vinayaka Missions Homoeopathic Medical College and Hospital |
| Address |
Department of Repertory Vinayaka Missions Homoeopathic Medical college and Hospital NH 47 Sankari Main Road Seeragapadi Po Salem Tamil Nadu 636308 India
Salem
TAMIL NADU
636308
India |
| Phone |
9080858096 |
| Fax |
|
| Email |
sivadharshinisenthil2310@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shilpa prasad |
| Designation |
Assistant Professor |
| Affiliation |
Vinayaka Missions Homoeopathic Medical College and Hospital |
| Address |
Department of Repertory Vinayaka Missions Homoeopathic Medical college and Hospital NH 47 Sankari Main Road Seeragapadi Po Salem Tamil Nadu 636308 India
Salem
TAMIL NADU
636308
India |
| Phone |
8281292904 |
| Fax |
|
| Email |
shilpaprasad007@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shilpa prasad |
| Designation |
Assistant Professor |
| Affiliation |
Vinayaka Missions Homoeopathic Medical College and Hospital |
| Address |
Department of Repertory Vinayaka Missions Homoeopathic Medical college and Hospital NH 47 Sankari Main Road Seeragapadi Po Salem Tamil Nadu 636308 India
Salem
TAMIL NADU
636308
India |
| Phone |
8281292904 |
| Fax |
|
| Email |
shilpaprasad007@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vinayaka Missions Homoeopathic Medical College and Hospital NH 47 Sankari Main Road Seeragapadi Post Salem Tamil Nadu 636308 India |
|
|
Primary Sponsor
|
| Name |
Vinayaka Missions Homoeopathic Medical College and Hospital |
| Address |
NH 47 Sankari Main Road Seeragapadi Post Salem Tamil Nadu 636308 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 Sivadharshini S |
Vinayaka Missions Homoeopathic Medical College and Hospital |
Department of Repertory Vinayaka Missions Homoeopathic Medical college and Hospital NH 47 Sankari Main Road Seeragapadi Po Salem Tamil Nadu 636308 India
Salem
TAMIL NADU |
9080858096
sivadharshinisenthil2310@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committe Vinayaka Mission Kirupananda Variyar Medical college and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J329||Chronic sinusitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Homoeopathic Remedy |
Homoeopathic medicines are selected based on individualization of the patient Based on the susceptibility of the patient the potency and dose is selected and Medicine is administered via oral route Follow up is taken once in every one month |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
The patient of age 21 to 40 years
Both sexes are included
First 3 stages of chronic rhinosinusitis will be included
Cases diagnosed using AAO-HNS diagnostic criteria with 2 or more symptoms will be included |
|
| ExclusionCriteria |
| Details |
Patient with immune compromised disease conditions
Patient with any other ENT illness, pregnant ladies and psychiatric illness are excluded
Patients of chronic rhinosinusitis complicated with other pathologies
Patients of chronic rhinosinusitis with nasal polyp
4 the stage of chronic rhinosinusitis will be excluded |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| It is expected that the proposed study will be useful in reducing the severity of sinus complaints and running nose |
At base line and at the end of study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Assessment of the patient is done through The European position paper on rhinosinusitis used as screening tool
American Academy of Otolaryngology-Head and Neck Surgery used as diagnostic criteria
Sino Nasal Outcome Test -22 to see the betterment of patient |
At baseline and at the end of study |
|
|
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)
|
02/12/2024 |
| 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="6"
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
|
Rhinosinusitis is defined as inflammation of
both nasal cavity and paranasal sinuses. Sinusitis will occur along with
inflammation in nasal mucosa. Hence, it is considered to be more acceptable name,
even though the fact that rhinosinusitis and sinusitis are used frequently
without interchanging. Symptoms like nasal blockage, increase
temperature from slight degree to heavy fever, sore throat, postnasal drip,
sneezing heaviness of head, nasal discharge, fascial pain will be present. There are two types of rhinosinusitis -acute
and chronic. Based on the timing of the symptoms they are determined as acute
and chronic. The prevalence of chronic rhinosinusitis
measure in epidemiologically between 5% to 12% in Indian population. Homoeopathy is a mode of treatment which is based on individualization and its holistic approach treats effectively without adverse effect. Homeopathy removes the cause of the disease and restore the healthy state of the body .The Homoeopathic similimum is one of the fundamental therapeutic procedure to treat various diseases.The present study aims at effectiveness of
homeopathic medicine in treating the chronic rhinosinusitis patients using
Synthesis repertory. Synthesis repertory 9.1, augmented edition contain mental,
physical and particular symptoms and corresponding group of remedies. The
remedy will be selected on the basis of generals (mental and physical symptoms).
Any case that contains generals and characteristic particular can be
repertorized by synthesis. A case with only characteristic particular can also
be repertorized. Using synthesis repertory 9.1 augmented edition almost all
type of cases can be repertorised. |