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CTRI Number  CTRI/2023/06/054109 [Registered on: 19/06/2023] Trial Registered Prospectively
Last Modified On: 15/06/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device
Ayurveda 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   A clinical trial to study the effect of Agnikarma with Pathyadi kwatha & Viddha karma with Pathyadi kwatha in Ardhavabhedaka ( Migraine )_ 
Scientific Title of Study   An open label double arm controlled clinical study of viddhakarma & pathyadi kwatha in the management of Ardhavabhedaka (Migraine ) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr PADMASHREE 
Designation  PG Scholar  
Affiliation  Sri Dharmasthala Manjunatheshwara institute of Ayurveda and hospital  
Address  Department of Shalakya Tantra Sri Dharmasthala Manjunatheshwara institute of Ayurveda and hospital Anchepalya Kumbalogodu post Bangalore Mysore Highway Bangalore

Bangalore
KARNATAKA
560074
India 
Phone  9986500898  
Fax    
Email  padmashree@sdmayurbangalore.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Mamatha K V  
Designation  Professor and HOD Dept Of Shalakya Tantra 
Affiliation  Sri Dharmasthala Manjunatheshwara institute of Ayurveda and hospital  
Address  Sri Dharmasthala Manjunatheshwara institute of Ayurveda and hospital Anchepalya Kumbalogodu post Bangalore Mysore Highway Bangalore -560074

Bangalore
KARNATAKA
560074
India 
Phone  9845393236  
Fax    
Email  mail2mamatha@sdmayurbangalore.in  
 
Details of Contact Person
Public Query  
Name  Dr Mamatha K V  
Designation  Professor and HOD Dept Of Shalakya Tantra 
Affiliation  Sri Dharmasthala Manjunatheshwara institute of Ayurveda and hospital  
Address  Sri Dharmasthala Manjunatheshwara institute of Ayurveda and hospital Anchepalya Kumbalogodu post Bangalore Mysore Highway Bangalore -560074


KARNATAKA
560074
India 
Phone  9845393236  
Fax    
Email  mail2mamatha@sdmayurbangalore.in  
 
Source of Monetary or Material Support  
Sri Dharmasthala Manjunatheshwara institute of Ayurveda and hospital Anchepalya Kumbalogodu post Bangalore Mysore Highway Bangalore  
 
Primary Sponsor  
Name  NIL 
Address  - 
Type of Sponsor  Other [] 
 
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 
DrPADMASHREE  Sri Dharmasthala Manjunatheshwara institute of Ayurveda and hospital   Sri Dharmasthala Manjunatheshwara institute of Ayurveda and hospital Department of shalakya tantra Anchepalya ,Kumbalogodu post Bangalore –Mysore Highway Bangalore -560074 India
Bangalore
KARNATAKA 		 9986500898

padmashree@sdmayurbangalore.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:G998||Other specified disorders of nervous system in diseases classified elsewhere. Ayurveda Condition: ARDHAVABEDAKAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-agnikarma, अग्निकर्म (Procedure Reference: Charaka and sushruta samhita, Procedure details: Agnikarma will be done with tapta shalaka yantra in bindu akara over most tender point )
(1) Medicine Name: pathyadi kwata, Reference: Sharangadara madhyama khanda, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 24(ml), Frequency: bd, Duration: 14 Days
2Intervention ArmProcedure-vyadhana-visrAvaNa-karma, व्यधन-विस्रावण-कर्म (Procedure Reference: Cakradatta, Procedure details: Pricking will be done with needle no 26 with depth about 1 to 2mm .Approximately 2 pricks given on each marked area)
(1) Medicine Name: Pathyadi kwata, Reference: Sharangadara madhyama khanda, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 24(ml), Frequency: bd, Duration: 14 Days
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1. Patients between 20-45 years of age irrespective of sex, religion, occupation and socio -economic status and willing to participate and provide consent will be included
2. Patient having minimum of one episode of headache in 7 days

3. Patients with signs and symptoms of Ardhavabhedaka and migraine

4. Patients attending OPD during Vegavastha of Ardhavabhedaka (Pain Phase of Migraine)
 
 
ExclusionCriteria 
Details  1. Patients contraindicated for Agnikarma and Raktha mokshana as per classics.

2. Patients with other primary headache like tension, cluster headache

3. Patients associated with secondary headache due to Glaucoma, Frontal sinusitis.

4. Patients with Systemic disorders ( Diabetes Mellitus, Hypertension)
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1.Improvement in the Subjective
and objective parameters
2.Improvement in the HIT-6
Questionnaire
3.Sustained effect of treatment in
reducing the episodes of
Migraine
4.Improvement changes in Midas
Questionnaire
5.A cost effective procedure which can be easily practiced
during pain phase
 		 one month 
 
Secondary Outcome  
Outcome  TimePoints 
nil  - 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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 2/ Phase 3 
Date of First Enrollment (India)   26/06/2023 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   It is a randomized open label double arm controlled clinical study to compare the efficacy of Viddha karma  during pain phase followed by which oral administration of  Pathyadi kwata  48ml in 2 divided dose for 2 weeks and Agnikarma during pain phase followed by  with which oral administration of  Pathyadi kwata  48ml in 2 divided dose for 2 weeks Ardhavabhedaka ( Migraine ) conducted in single center. 
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