| CTRI Number |
CTRI/2023/12/060810 [Registered on: 27/12/2023] Trial Registered Prospectively |
| Last Modified On: |
21/12/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison on the efficacy of Epleys Maneuver and its combination with Ayurvedic management which includes Kalyanaka grita Nasya,internal administration of Drakshadi kashaya and Eladi vati in the condition Benign Paroxysmal Positional Vertigo(BPPV). |
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Scientific Title of Study
|
Comparative assessment on the efficacy of Epleys Maneuver and its combination with Kalyanaka grita Nasya,Drakshadi kashaya,Eladi vati in the management of Benign Paroxysmal Positional Vertigo(BPPV). |
| Trial Acronym |
NIL |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Praveena Nair |
| Designation |
Second year PG scholar,Department of Shalakya tantra |
| Affiliation |
Department of Shalakyatantra,Amrita school of Ayurveda |
| Address |
Amrita school of Ayurveda,
Amritapuri campus,Clappana P.O,
Kollam -690525,Kerala,india
Kollam KERALA 690525 India |
| Phone |
9567424188 |
| Fax |
|
| Email |
pveenagvr@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr K.Sivabalaji |
| Designation |
Associate professor, Department of Shalakyatantra |
| Affiliation |
Department of Shalakya tantra,Amrita school of Ayurveda |
| Address |
Amrita school of Ayurveda,
Amritapuri campus,Clappana P.O,
Kollam -690525,Kerala,india
Kollam KERALA 690525 India |
| Phone |
7559027947 |
| Fax |
|
| Email |
balajisiva85k@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Praveena Nair |
| Designation |
Second year PG scholar,Department of Shalakya tantra |
| Affiliation |
Department of Shalakyatantra,Amrita school of Ayurveda |
| Address |
Amrita school of Ayurveda,
Amritapuri campus,Clappana P.O,
Kollam -690525,Kerala,india
Kollam KERALA 690525 India |
| Phone |
9567424188 |
| Fax |
|
| Email |
pveenagvr@gmail.com |
|
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Source of Monetary or Material Support
|
| Amrita school of Ayurveda
Amritapuri campus,Clappana P.O,
Kollam -690525 |
|
|
Primary Sponsor
|
| Name |
Dr Praveena Nair |
| Address |
Amrita school of Ayurveda,
Amritapuri campus,Clappana P.O,
Kollam -690525,Kerala,india |
| Type of Sponsor |
Other [Self] |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
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Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Praveena Nair |
Amrita school of Ayurveda |
Shalakya tantra OPD(OPD-2)Amrita school of Ayurveda,
Amritapuri campus,Clappana P.O,
Kollam -690525,Kerala,india Kollam KERALA |
09567424188
pveenagvr@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC, Amrita school of Ayurveda |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H829||Vertiginous syndromes in diseasesclassified elsewhere, unspecified ear. Ayurveda Condition: BRAMAH, |
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | nAvanam, नावनमॠ| (Procedure Reference: Ashtanga hridaya sutrasthana, Procedure details: instillation of 4ml medicine in each nostril for 7 days.) (1) Medicine Name: Kalyanka grita, Reference: Charaka samhitha chikitsasthana, Route: Nasal, Dosage Form: Ghrita, Dose: 4(ml), Frequency: od, Duration: 7 Days(2) Medicine Name: Drakshadi kashaya choorna, Reference: Ashtanga hridaya chikitsasthana, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 20(ml), Frequency: bd, Duration: 30 Days(3) Medicine Name: Eladi Vati, Reference: Bhaishajaya ratnavali , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 12(g), Frequency: bd, Duration: 30 Days | | 2 | Comparator Arm | Lifestyle | - | - | Dinacarya: , Ritucarya: , Acara Rasayana:, Other:Epley maneuver, Pathya/Apathya:, Pathya:, Apathya: | | 3 | Comparator Arm (Non Ayurveda) | | - | Epley Maneuver | Weekly once administration for 1 month |
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Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients of age 35-70.
2.Patients presenting vertigo with or without nystagmus following the DHP.
3.Patients fit for nasya karma.
4.Patient willing to take internal medication.
5.Patient with Vertigo symptom scale-short form(VSS-SF) score upto 45
6.Patient with Dizziness
handicap inventory(DHI) score upto 80. |
|
| ExclusionCriteria |
| Details |
1.Patients who doesn’t fit the diagnostic criteria.
2.Patients who are contra-indicated for Canalith repositioning maneuver
3.Pregnant and breast feeding patients.
DIAGNOSTIC CRITERIA :
1.Recurrent attacks of positional vertigo or positional dizziness provoked by lying down or
turning over in supine position.
2.Duration of attacks less than 1 min.
3.Positional nystagmus elicited after a latency of only few seconds by Dix Hallpike
manuever.
4.Not attributable to another disorder. |
|
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Method of Generating Random Sequence
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Coin toss, Lottery, toss of dice, shuffling cards etc |
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Method of Concealment
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Alternation |
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Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
1. Vertigo symptom scale (VSS sf ) – least total score.
2. Dizziness Handicap Inventory( DHI)- least total score.
3. Dix Hallpike test (DHP test)- negative test. |
after 1 month |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
1. Vertigo symptom scale (VSS sf ) – least total score.
2. Dizziness Handicap Inventory( DHI)- least total score.
3. Dix Hallpike test (DHP test)- negative test. |
pre & post treatment,during 4 followups during 45th,60th,75th,90th day |
|
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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" |
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Phase of Trial
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N/A |
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Date of First Enrollment (India)
|
15/02/2024 |
| 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 |
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Estimated Duration of Trial
|
Years="1" Months="5" Days="30" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
N/A |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form Response - Clinical Study Report Response - Analytic Code
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Data are available indefinitely at (Link to be included Nil).
- For how long will this data be available start date provided 01-12-2026 and end date provided 01-01-2035?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
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Brief Summary
|
BPPV is characterized by vertigo lasting for seconds associated with balancing problem, nystagmus, nausea and vomiting. It is the most common cause of vertigo worldwide with a prevalence of 10.7 - 140/100,000.Though it is a benign condition, 60 % of patients with BPPV require leave from work, 86 % experience interruption to activities of daily living, 38 % of patients fall down as a direct consequence, with incidence of both BPPV and falls increasing with increasing age. Treatment recommendation include Canalith repositioning procedure(CRP), vestibular suppression medications and rehabilitative exercises. Despite the success of CRP showing odds ratio of 4.2 in resolution of symptoms 20% of BPPV doesnot benefit from it and shows mild negative outcomes. Vestibular medications are also not advised for long as it produces drowsiness, Cognitive deficits , Interference with driving vehicles or operating machineries. Datas are also not available showing widely accepted interval regarding CRP. Reviewing the classics the symptoms of BPPV can be correlated to bhrama where a person feels that everything around him is spinning like a wheel “chakravat bhramana†caused due to the vitiation of pitta and vata with involvement of raja. Line of treatment can be according to doshapratyaneekata and its site of manifestation. In the present study kalyanaka grita nasya is chosen. Drakshadi kashaya and eladi vati selected for internal administration is vatapittahara tridoshahara respectively and both are advised to be effective in bhrama. Hence the present study is to assess whether Kalyanaka grita nasya, Drakshadi kashaya, Eladi vati with Epley’s Maneuver is more effective than Epley’s Maneuver alone in the management of BPPV. The clinical study will be carried out in 30 patients with BPPV who fulfil inclusion criteria belonging to either sex from OPD and IPD of Amrita School of Ayurveda. VSS- sf, DHI questionnaire and Dix Hallpike test will be assessed. Patient will be allocated into Group A and B. Consent will be taken in their own language before treatment, subjective parameters will be assessed and recorded in CRF. Group A will be given 4ml Kalyanaka grita marsha nasya, Drakshadi kashaya and eladi vati along with Epleys manuever and group B with Epley’s maneuver alone for 30 days. After treatment subjective parameters will be assessed, also in the 4 followup on 45th,60th,75th ,90th day to assess the sustained effect of treatment . The data obtained will be tabulated and statistically analysed using Wilcoxon signed rank test. |