| CTRI Number |
CTRI/2025/12/099259 [Registered on: 16/12/2025] Trial Registered Prospectively |
| Last Modified On: |
05/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
STUDY ON THE EFFECTIVENESS OF INDIVIDUALIZED HOMOEOPATHIC TREATMENT FOR BENIGN POSITIONAL VERTIGO IN THE AGE GROUP OF 40-70YRS |
|
Scientific Title of Study
|
A PROSPECTIVE STUDY TO ASSESS THE EFFICACY OF INDIVIDUALIZED HOMOEOPATHIC MEDICINES IN THE MANAGEMENT OF BENIGN PAROXYSMAL POSITIONAL VERTIGO IN AGE GROUP OF 45-65YRS USING VERTIGO SYMPTOM SCALE |
| 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 Akshata |
| Designation |
PG Scholar |
| Affiliation |
AM Shaikh Homoeopathic Medical College And Hospital Belgaum |
| Address |
AM Shaikh Homoeopathic Medical College, PG Research Centre And Hospital, Department Of Practice of Medicine, Second Floor, PG Section, Shaikh Campus, Nehru Nagar, Belagavi, Karnataka, India
590010
Belgaum KARNATAKA 590006 India |
| Phone |
8792852495 |
| Fax |
|
| Email |
akshatapatil0411@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Jyothi Vijaykumar |
| Designation |
HOD and PG Guide |
| Affiliation |
AM Shaikh Homoeopathic Medical College And Hospital Belgaum |
| Address |
AM Shaikh Homoeopathic Medical College, PG Research Centre And Hospital, Department Of Practice of Medicine, Second Floor, PG Section, Shaikh Campus, Nehru Nagar, Belagavi, Karnataka, India
590010
Belgaum KARNATAKA 590010 India |
| Phone |
9964357653 |
| Fax |
|
| Email |
Jyothivijaykumar3@yahoo.co.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Jyothi Vijaykumar |
| Designation |
HOD and PG Guide |
| Affiliation |
AM Shaikh Homoeopathic Medical College And Hospital Belgaum |
| Address |
AM Shaikh Homoeopathic Medical College, PG Research Centre And Hospital, Department Of Practice of Medicine, Second Floor, PG Section, Shaikh Campus, Nehru Nagar, Belagavi, Karnataka, India
590010
Belgaum KARNATAKA 590010 India |
| Phone |
9964357653 |
| Fax |
|
| Email |
Jyothivijaykumar3@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Dr. Akshata AM Shaikh Homoeopathic Medical College, PG Research Centre And Hospital, Department Of Practice of Medicine, Second Floor, PG Section, Shaikh Campus, Nehru Nagar, Belagavi, Karnataka, India - 590010 |
|
|
Primary Sponsor
|
| Name |
Dr Akshata |
| Address |
AM Shaikh Homoeopathic Medical College, PG Research Centre And Hospital, Department Of Practice of Medicine, Second Floor, PG Section, Shaikh Campus, Nehru Nagar, Belagavi, Karnataka, India - 590010 |
| 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 Akshata |
AM Shaikh Homoeopathic Medical College And Hospital Belgaum |
AM Shaikh Homoeopathic Medical College, PG Research Centre And Hospital, Department Of Practice Of Medicine, Second Floor, PG Section, Shaikh Campus, Nehru Nagar, Belagavi, Karnataka, India -590010
Belgaum
KARNATAKA Belgaum KARNATAKA |
8792852495
akshatapatil0411@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICAL CLEARANCE FOR RESEARCHSTUDY |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H811||Benign paroxysmal vertigo, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized Homoeopathic Medicine |
The intervention involves the administration of individualized homoeopathic remedy in 30th potency, to individuals suffering from benign paroxysmal positional vertigo; one dose as per requirement of the case. The treatment aims to reduce the frequency and intensity of vertiginous symptoms, as measured by the VSS-SF(Vertigo Symptom Scale Short form). The remedy will be administered in oral pellet form, with the patient dissolving the pellets under the tongue. The dosage regimen may involve taking a single dose or repeated doses depending on the severity and clinical judgment. The precise dosage and frequency will be determined on an individual basis. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Subjects which are positive in Dix Hallpike Test i.e. those who get only vertigo symptom after performing maneuver.
Individuals who are also already diagnosed with BPPV.
Subjects who score more than 6.5 on Vertigo symptom scale |
|
| ExclusionCriteria |
| Details |
Subjects having history of head trauma or previous surgery (stapedectomy) and Other secondary causes of vertigo such as Meniere disease, vestibular neuronitis, infections, migraine.
Patients with history of cerebrovascular disease or any systemic illness such as hypertension, diabetes.
Pregnant and lactating women
Patients who are already taking conventional treatment or Epley maneuver for BPPV
Those who show only nystagmus after Dix Hallpike Test
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction of more than or equal to three points from the baseline score on VSS-SF after giving individualized homoeopathic medicines. |
Baseline (Day 0) & Last Follow up (Day180)
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="52" Sample Size from India="52"
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)
|
13/01/2026 |
| 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="3" 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
|
Benign Paroxysmal Positional Vertigo (BPPV) is a common peripheral vestibular disorder causing brief episodes of positional vertigo that significantly affect daily functioning and quality of life. Conventional treatment such as Epley’s maneuver and vestibular suppressant drugs offers symptomatic relief but may not be suitable for all patients and may not prevent recurrences. This prospective interventional study aims to assess the efficacy of individualized Homoeopathic medicines in managing subjective and idiopathic BPPV among individuals aged 40–70 years. A total of 52 participants with positive Dix–Hallpike Test findings and elevated Vertigo Symptom Scale–Short Form (VSS-SF) scores will receive individualized Homoeopathic treatment based on totality of symptoms. Severity of vertigo will be evaluated using VSS-SF before and after intervention during monthly follow-ups for six months. The primary outcome will be the reduction in VSS-SF scores, indicating improvement in vertigo symptoms. The study intends to determine whether individualized Homoeopathic medicines can provide effective, safe, and holistic management of BPPV and improve overall symptom burden. |