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CTRI Number  CTRI/2022/12/047939 [Registered on: 07/12/2022] Trial Registered Prospectively
Last Modified On: 06/12/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   To see the effect of Shirodhara and Shiroabhyanga in the treatment of Hypertension 
Scientific Title of Study   “A clinical study to evaluate the efficacy of Takra Shirodhara along with Ksheer Bala Tail Shiro Abhyanga in the management of Raktagata Vata (Essential Hypertention)”  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Pooja Kumari Dhakar 
Designation  MD Scholar 
Affiliation  UPGIASR DSRRAU 
Address  PG Department Of Panchakarma University Post Graduate Institute Of Ayurveda Studies And Research Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University

Jodhpur
RAJASTHAN
342037
India 
Phone  9828954623  
Fax    
Email  poojadhakar623@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Gyan Prakash Sharma 
Designation  HOD & Associate Professor 
Affiliation  UPGIAS&R DSRRAU 
Address  PG Department Of Panchakarma University Post Graduate Institute Of Ayurveda Studies And Research Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University

Jodhpur
RAJASTHAN
342037
India 
Phone  9829798701  
Fax    
Email  atreyagyan@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Pooja Kumari Dhakar 
Designation  MD Scholar 
Affiliation  UPGIASR DSRRAU 
Address  PG Department Of Panchakarma University Post Graduate Institute Of Ayurveda Studies And Research Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University

Jodhpur
RAJASTHAN
342037
India 
Phone  9828954623  
Fax    
Email  poojadhakar623@gmail.com  
 
Source of Monetary or Material Support  
Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Jodhpur 
 
Primary Sponsor  
Name  Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Jodhpur 
Address  Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Karwar Nagur Road Jodhpur Pin 342037 
Type of Sponsor  Government medical college 
 
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 Pooja kumari Dhakar  Dr Sarvepalli Radhakrishnan Rajasthan Ayurveda University Hospital Of Ayurveda  OPD NO 7 PG Department Of Panchakarma Dr Sarvepalli Radhakrishnan Rajasthan Ayurveda University Karwar Nagur Road Jodhpur Pin 342037 Rajasthan
Jodhpur
RAJASTHAN 		 9828954623

poojadhakar623@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
The Institutional Ethics Committee UPGIAS&R Jodhpur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:I10||Essential (primary) hypertension. Ayurveda Condition: RAKTAVRUTAVATAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-SiraHsekaH, शिरःसेकः (Procedure Reference: Dharakalpa, Procedure details: Pouring of any liquid/medicated liquid (milk, oil etc) over the forehead by specific technique is known as Shirodhara. Time 45 minute per day.)
(1) Medicine Name: Takra, Reference: Dharakalpa, Route: Topical, Dosage Form: Kwatha/Kashaya, Dose: 2000(ml), Frequency: od, Duration: 14 Days
2Intervention ArmProcedure-Siro~aBya~ggaH, शिरोरऽभ्यंग (Procedure Reference: Charak, Procedure details: Shiroabhyanga is a complete massage of Head, Neck and Shoulders using Ksheerbala taila. Time 15 minute per day. )
(1) Medicine Name: Ksheerbala taila, Reference: Shastra yoga, Route: Topical, Dosage Form: Taila, Dose: 30(ml), Frequency: od, Duration: 14 Days
 
Inclusion Criteria  
Age From  35.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1.Patient With Cardinal Symptoms Of Hypertension.
2. Patient Previously Diagnosed With Hypertension, Systolic Blood Pressure Between 140-160 Mm Of Hg (Grade 1) Within 5year Prior To Start The Trial.
3. Patient Willing To Sign The Consent Form.
 
 
ExclusionCriteria 
Details  1. Patients With Age Below 35 Years And Above 70year.
2. Patient Having Secondary Hypertension.
3. Patient With Malignant Hypertension I.E. Blood Pressure Above 200/140mm Of Hg.
4. Having Any Other Serious Illness Like Coronary Artery Disease, Cerebrovascular Disease,
Renal Function Impairment.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Subjective Criteria
Severity Scoring Of Shiroshool (Headache)
Bhrama (Giddiness)
Klama(Fatigue)
Hritspandan(Palpitation)
Swedadhikyata(Excessive Sweating)
Anidra(Insomnia)
Objective Criteria
Sphygmomanometer
 		 45 days 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
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   Phase 3/ Phase 4 
Date of First Enrollment (India)   10/12/2022 
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)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NA 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
Raktagata vata (Hypertension) is a type of Vata vyadhai, in which vitiation of Vata dosha in Rakta causes pain in whole body, increased Temprature, Vivarnta (discoloration), Krishta(emaciation), Aruchi (anorexia), Arunshika(boil) in whole body and Anna Stambha etc. symptoms appears. Most of efforts shows a prime role of Vata in association of remaining dosha pitta and kapha. Rraktagata vata somewhat resembles Hypertension. It is a disease of circulatory system, in which systemic arterial blood pressure elevate beyond the normal value (more then 130 /85mm of hg). In allopathy various Antihypertensive drugs like Beta blockers, Calcium channel blockers, Diuretics thiazide, ACE inhibitors are being used to decrease blood pressure, However these drugs are producing several Adverse Effects like feeling nervous erection problem. dizziness, feeling tired, headache, nausea or vomiting, so we looking to alternative system especially Ayurveda and find out solution to increase Blood Pressure. The study is open labelled Randomised to prove the efficacy of Takra Shirodhra along with Ksheer Bala tail Shiro abhyanga in the management of Raktagata vata (Essential Hypertension). In this Study 30 patients will be registered for Shiroabhyanga And Shirodhara. 
 
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