| CTRI Number |
CTRI/2025/03/082443 [Registered on: 17/03/2025] Trial Registered Prospectively |
| Last Modified On: |
12/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Homoeopathic medicines for vertigo |
|
Scientific Title of Study
|
The effect of individualized homoeopathic medicine
in centesimal potency in treatment of
Benign Paroxysmal Positional Vertigo:
An open label, single arm, prospective study
in adults
|
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1318-3915 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anik Dey |
| Designation |
Post Graduate Trainee |
| Affiliation |
The Calcutta Homoeopathic Medical College and Hospital |
| Address |
THE CALCUTTA HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL
265 266 Acharya Prafulla Chandra Road Kolkata - 700009 West Bengal, Practice of Medicine OPD, Room no- 17 and 21
265 266 Acharya Prafulla Chandra Road Kolkata - 700009 West Bengal, Practice of Medicine OPD, Room no- 17 and 21
Kolkata
WEST BENGAL
700009
India |
| Phone |
7407397050 |
| Fax |
|
| Email |
deyanik.bwn@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Himangsu Hait |
| Designation |
PROFESSOR & HOD Practice of Medicine |
| Affiliation |
The Calcutta Homoeopathic Medical College and Hospital |
| Address |
THE CALCUTTA HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL
265 266 Acharya Prafulla Chandra Road Kolkata - 700009 West Bengal, Practice Of Medicine OPD, Room no- 17 and 21
265 266 Acharya Prafulla Chandra Road Kolkata - 700009 West Bengal, Practice Of Medicine OPD, Room no- 17 and 21
Kolkata
WEST BENGAL
700009
India |
| Phone |
9433565680 |
| Fax |
|
| Email |
drhaithait@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Himangsu Hait |
| Designation |
PROFESSOR & HOD Practice of Medicine |
| Affiliation |
The Calcutta Homoeopathic Medical College and Hospital |
| Address |
THE CALCUTTA HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL
265 266 Acharya Prafulla Chandra Road Kolkata - 700009 West Bengal, Practice Of Medicine OPD, Room no- 17 and 21
265 266 Acharya Prafulla Chandra Road Kolkata - 700009 West Bengal, Practice Of Medicine OPD, Room no- 17 and 21
Kolkata
WEST BENGAL
700009
India |
| Phone |
9433565680 |
| Fax |
|
| Email |
drhaithait@gmail.com |
|
|
Source of Monetary or Material Support
|
| The Calcutta Homoeopathic Medical College and Hospital
265, 266 Acharya Prafulla Chandra Road, Kolkata - 700009, West Bengal |
|
|
Primary Sponsor
|
| Name |
THE CALCUTTA HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL |
| Address |
265, 266 Acharya Prafulla Chandra Road, Kolkata - 700009, 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 Anik Dey |
The Calcutta Homoeopathic Medical College and Hospital |
Department of Practice of Medicine, Room no 17 AND 21, 265, 266 Acharya Prafulla Chandra Road, Kolkata - 700009, West Bengal
Kolkata
WEST BENGAL |
7407397050
deyanik.bwn@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Insttutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H829||Vertiginous syndromes in diseasesclassified elsewhere, unspecified ear, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized homjoeopathic medicines in centesimal potencies with concomitant care |
Intervention is planned as administering
indicated homoeopathic medicines in centesimal potency. Each dose will
consist of 1 cane sugar globule no. 40 moistened with the indicated GMP
certified medicine, to be taken orally on a clean tongue on empty
stomach; dosage and repetition depend upon the individual requirement
of the cases. Patients will be advised to refrain from handling the globules or from eating, drinking, smoking or brushing their teeth within 30
minutes of taking the globules and will be asked to suck the globules
rather than simply swallowing those. Single individualized
homoeopathic medicine will be given on each occasion taking into
consideration the presenting symptom totality, clinical history details,
constitutional features, miasmatic expressions, and repertorisation using
HOMPATH ZOMEO software with due consultation of Materia Medica
and due consensus among three homoeopaths. Duration of therapy- 3 months. Follow up should be done every 1 month for 3 months. |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients experiencing spinning sensations for short duration (Paroxysmal): Lasts only seconds to minutes (usually less than 60 seconds) which is triggered by change of positions of head like tilting the head, rolling over in bed, looking up or under, sudden head motion.associated with nystagmus (ICD-11 diagnostic code AB31.2); confirmed by positive Dix-Hallpike manoeuvre or positive horizontal roll test.
2. Age between 18-65 years.
3. Patients of all sexes including transgenders.
4. Literate patients; ability to read English, Bengali or Hindi and illiterate people will be interviewed by the investigators maintaining adequate privacy to fill up the scales or questionnaires.
5. Willing to take part in the study and give written informed consent voluntarily.
|
|
| ExclusionCriteria |
| Details |
1. Vertigo due to causes other than BPPV. Patients having central vertigo which is excluded by HINTS examination. (i.e Head impulse, Nystagmus, Test of Skew)
2. Patients suffering from hypertension, hypotension, anaemic, uncontrolled diabetes mellitus, cardiovascular diseases, cervical spondylosis.
3. Patient having psychological or mental instability.
4. Use of labyrinthine suppressants in past 2 weeks.
5. Patients taking any drugs that causes dizziness, light headedness.
6. Unconscious, non-ambulatory, too ill for consultation, differently abled, terminally ill or critically ill patients, mentally disabled people.
7. Pregnant and postpartum women, nursing mothers.
8. Patients with the habit of tobacco chewing and/or smoking, alcoholism and/or any other forms of substance abuse and/or dependence.
9. Self-reported immune-compromised condition.
10. Already been in homoeopathic treatment for any chronic illness for the last 6 months.
11. Simultaneous participation in any other clinical trial
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary outcome: 5 item BPPV sub-scale of DHI- A summation of the following five items from the DHI: 1) looking up, 2) getting out of bed, 3) quick head movements, 4) rolling over in bed, and 5) bending. Scores are in the range of 0-4 for each item (Always to No); thus total score ranges from 0 to 20; higher score indicates worse symptoms.
|
At baseline, every 4 weeks, up to 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To detect the differences in sign and symptoms during the treatment of BPPV by
using DHI Scales (25 items) after 3 months of intervention.
and to shortlist the most frequently indicated medicines in BPPV with their
indications. |
At baseline, every 4 weeks, up to 3 months |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
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)
|
01/04/2025 |
| 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 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
|
Benign paroxysmal positional vertigo is clinically characterized by recurrent spells of
vertigo, lasting a few minutes, associated with changes in head position often provoked
by rolling over in bed. The typical symptoms of BPPV occur in clusters
that persist for several days. There is a brief (10–15 sec) latency period following a head
movement before symptoms develops, and the acute vertigo subsides within 10–60
seconds, though the patient may remain imbalanced for several hours. It occurs due to free-floating debris/otoliths in the semicircular canal (canalolithiasis) or debris/otoliths
attached to the cupula (cupulolithiasis). These debris/otoliths are considered to
originally accumulate after detachment from the neuroepithelium of the utricular macula
secondary to a type of degeneration. The pathology is based on displacement of the
cupula due to either free-floating debris/otoliths in the semicircular canal or attachment
of debris/otoliths to the cupula. Following obtaining screening & consent using specified selection (inclusion and exclusion) criteria, 34 eligible Participants will be included in the trial and Individualized homoeopathic medicine will be prescribed on the basis of totality of symptoms. Patients will be followed up every four weeks interval for three months. Following that, baseline outcome data 5 item BPPV sub scale of DHI , DHI (25 items) to be obtained. |