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CTRI Number  CTRI/2023/11/059494 [Registered on: 03/11/2023] Trial Registered Prospectively
Last Modified On: 05/01/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Marma treatment and internal medicine for positional vertigo 
Scientific Title of Study   Development of treatment protocol wrt marma chikitsa with karnapoorana and internal medication in bhrama wsr to benign paroxysmal positional vertigo - A pilot 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 Adharsh Ganesh S K 
Designation  PG Scholar 
Affiliation  KAHERS SHRI BMK Ayurveda Mahavidyalaya 
Address  Department of Shalakya Tantra KAHER Shri BMK Ayurveda Mahavidyalaya Shahpur

Belgaum
KARNATAKA
590003
India 
Phone  9480486050  
Fax    
Email  adharshganesh222@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Adharsh Ganesh S K 
Designation  PG Scholar 
Affiliation  KAHER SHRI BMK Ayurveda Mahavidyalaya 
Address  Department of Shalakya Tantra KAHER Shri BMK Ayurveda Mahavidyalaya Shahpur Belagavi OPD no 26 & 27

Belgaum
KARNATAKA
590003
India 
Phone  9480486050  
Fax    
Email  adharshganesh222@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Adharsh Ganesh S K 
Designation  PG Scholar 
Affiliation  KAHERS SHRI BMK Ayurveda Mahavidyalaya 
Address  Deprtment of Shalakya Tantra KAHER Shri BMK Ayurveda Mahavidyalaya Shahpur Belagavi

Belgaum
KARNATAKA
590003
India 
Phone  9480486050  
Fax    
Email  adharshganesh222@gmail.com  
 
Source of Monetary or Material Support  
KAHERS Shri BMK Ayurveda Mahavidyalaya  
 
Primary Sponsor  
Name  KAHERS Shri BMK Ayurveda Mahavidyalaya  
Address  KAHERS Shri BMK Ayurveda Mahavidyalaya Belagavi Shahur 
Type of Sponsor  Research institution and hospital 
 
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 Adharsh Ganesh S K  KAHERS Shri BMK A yurveda Mahavidyalaya Shahpur Belagavi   Room No. 26 & 27 Department of Shalakyatantra
Belgaum
KARNATAKA 		 9480486050

adharshganesh222@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethicl committee for research on human subjects  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:H811||Benign paroxysmal vertigo. Ayurveda Condition: BRAMAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-marmacikitsA, मर्मचिकित्सा (Procedure Reference: Marma Chikitsa CCRAS 2020, Procedure details: Karnapoorana with poorva & paschath marma chikitsa for 7 days of 2 cycles Duralabha kwatha 15ml-15ml-15ml after food )
(1) Medicine Name: Duralabha , Reference: Chakradutta Murcha chikitsa 17th chapter and 8th shloka, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 15(ml), Frequency: tds, Duration: 30 Days
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patient who are complaining with any signs and symptoms of BPPV
Patients who are willing to participate in the study by giving informed consent 
 
ExclusionCriteria 
Details  Vertigo caused by other than BPPV like meningitis encephelitis etc
Individuals having high myopia and glaucoma
Severe occular trauma
Pregnant women
Uncontrolled DM and HTN
Mentally retarded patients
Individuals having any secondary diseases like carcinoma tuberculosis 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
The efficacy of the marma chikitsa is assessed by seeing the reduction in the symptoms of positional vertigo  baseline 25th day 
 
Secondary Outcome  
Outcome  TimePoints 
Improving the quality of life   baseline is 30 days 
 
Target Sample Size   Total Sample Size="10"
Sample Size from India="10" 
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 4 
Date of First Enrollment (India)   12/11/2023 
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="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
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  

       According to WHO Vertigo affects a substantial number of individuals worldwide, with estimates suggesting that up to 20%-30% of the population will experience vertigo at some point in their lives. BPPV being one of the type of peripheral vertigo is the most prevelant amongst vertigo, which accounts for 32% of all peripheral vertigo.(1) There are only limited research that are been done on vertigo condition. For the treatment of vertigo, in the line of ayurveda there are less expensive and effective methods. The line of treatment of Bhrama(Vertigo) according to Ayurveda as internal medication with any bhramahara drugs and topical procedures like karnapoorana, karnadhoopana . Considering all this, the study is planned to find the treatment protocol with karnapoorana and internal medication & an additional marma chikitsa.


Karnapoorana - 

•Karnapoorana procedure is filling of medicated Taila, Mutra, and swarasa , etc for treatment of various Karna rogas.
 
Marma chikitsa
 Pressure points where pressure is applied poorva and paschat of karnapoorana
•Vidhura Marma – ½ Angula size – Snayu marma, Vaikalyakara
•Sthapani Marma – ½ Angula size – Sira Marma, vishalyaghna
•Utkshepa Marma – ½ Angula size – Snayu Marma, vishalyaghna
•Krikatika marma – ½ Angula size –  Sandhi marma, Vaikalyakara
Drug Review - 
•Bilva moola has the property of balancing Tridoshas and taila being predominantly vata shamaka, helps in this particular condition.
•Duralabha kwatha with ghrita as anupana is mentioned as bhramahara yoga by chakradatta in murcha chikitsa. 

Hypothesis - 
•H0 – The developed treatment protocol (marma chikitsa, Karna poorana, and internal medication) will not help in curing bhrama and in patient’s wellbeing w.r.t BPPV.
•H1 - The developed treatment protocol (marma chikitsa, Karna poorana, and internal medication) helps in curing bhrama w.r.t BPPV.

 
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