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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). 
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 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
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  
 
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] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
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 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC, Amrita school of Ayurveda  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:H829||Vertiginous syndromes in diseasesclassified elsewhere, unspecified ear. Ayurveda Condition: BRAMAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-nAvanam, नावनम् (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
2Comparator ArmLifestyle--Dinacarya: , Ritucarya: , Acara Rasayana:, Other:Epley maneuver, Pathya/Apathya:, Pathya:, Apathya:
3Comparator Arm (Non Ayurveda)-Epley ManeuverWeekly once administration for 1 month
 
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. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
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 
 
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 
 
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)   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 
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 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. 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

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Data are available indefinitely at (Link to be included Nil).

  6. 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.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
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.

 
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