| CTRI Number |
CTRI/2024/09/073226 [Registered on: 02/09/2024] Trial Registered Prospectively |
| Last Modified On: |
31/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Homoeopathic treatment in chronic hoarseness |
|
Scientific Title of Study
|
Effectiveness of Individualized Homoeopathic Medicine in Chronic Hoarseness- A single arm clinical interventional 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 Sivabalan S |
| Designation |
PG Scholar - Department of Practice of Medicine |
| Affiliation |
National Homoeopathy Research Institute in Mental Health, Kottayam |
| Address |
Department of Practice of Medicine, National Homoeopathy Research Institute in Mental Health, Kurichy, Sachivothamapuram PO
Kottayam
KERALA
686532
India |
| Phone |
8667320879 |
| Fax |
|
| Email |
dr.sivabalanbhms@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vinitha E R |
| Designation |
Associate Professor, Research Officer - Scientist - II, Department of Practice of Medicine |
| Affiliation |
National Homoeopathy Research Institute in Mental Health, Kottayam |
| Address |
Department of Practice of Medicine, National Homoeopathy Research Institute in Mental Health, Kurichy, Sachivothamapuram PO
Kottayam
KERALA
686532
India |
| Phone |
9567847444 |
| Fax |
|
| Email |
vinitha_sajeev@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vinitha E R |
| Designation |
Associate Professor, Research Officer - Scientist - II, Department of Practice of Medicine |
| Affiliation |
National Homoeopathy Research Institute in Mental Health, Kottayam |
| Address |
Department of Practice of Medicine, National Homoeopathy Research Institute in Mental Health, Kurichy, Sachivothamapuram PO
Kottayam
KERALA
686532
India |
| Phone |
9567847444 |
| Fax |
|
| Email |
vinitha_sajeev@yahoo.in |
|
|
Source of Monetary or Material Support
|
| National Homoeopathy Research Institute in Mental Health, Kurichy, Sachivothamapuram PO, Kottayam, Kerala - 686532. |
|
|
Primary Sponsor
|
| Name |
Dr Sivabalan S |
| Address |
National Homoeopathy Research Institute in Mental Health, Kurichy, Sachivothamapuram PO, Kottayam, Kerala - 686532. |
| Type of Sponsor |
Other [SELF] |
|
|
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 Sivabalan S |
National homoeopathy research institute in mental health |
outpatient department unit under department of Practice of Medicine
Kottayam
Kottayam
KERALA |
8667320879
dr.sivabalanbhms@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R490||Dysphonia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
INDIVIDUALIZED HOMOEOPATHIC MEDICINE |
The indicated homoeopathic medicine with any potency ranging from 6C to 50M (as per need of the case) will be administered orally. Each case will be reviewed at every 4 weeks interval or at a shorter interval for 6 months, according to the severity of the case. Potency, repetition and change of remedy will be adjusted as per the necessity of the follow up. |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Age group between 18-60 years of both sexes
2. Patients with rough, husky voice.
3. Patients with hoarseness lasting more than 14 days |
|
| ExclusionCriteria |
| Details |
1. Patients with underlying immune deficiencies, carcinoma.
2. Patients with congenital malformation of larynx
3. Chronic tobacco use and heavy alcohol use
4. Pregnant and lactating women
5. Patients with serious systemic illness
6. Patients with abnormal TSH value |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Changes in GRBASI score after administration of IHM
|
every 4 weeks, from baseline till the conclusion of the study at 6th month. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in the voice handicap index score after administering the IHM |
once every 4 weeks, from baseline till the conclusion of the study at 6th month. |
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
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)
|
12/09/2024 |
| 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 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
|
This study is a single arm, clinical interventional study to
determine the effectiveness of Individualized Homoeopathic Medicines in Chronic hoarseness that will be conducted in OPD, IPD of
Department of Practice of medicine at National Homoeopathy Research Institute in
Mental Health, Kottayam. The primary outcome measures will be, the
reduction in the severity of symptoms; assessed using the GRBASI every monthly. The secondary outcome will
be, the changes in the VOICE HANDICAP INDEX every month. As the study is one of its kind, it aims to make the efforts
to offer possibilities for future research in the effectiveness of
Individualized Homoeopathic Medicines in chronic hoarseness. |