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CTRI Number  CTRI/2020/11/029219 [Registered on: 19/11/2020] Trial Registered Prospectively
Last Modified On: 18/11/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   A clinical trial to study the effect of Aarogyavardhini vati with Aaragdhwadha phala majja ksheerpaka in patient with high blood pressure. 
Scientific Title of Study   EFFICACY OF AAROGYAVARDHINI VATI WITH AARAGWADHA PHALA MAJJA KSHEERPAKA [CASSIA FISTULA LINN] IN THE MANAGEMENT OF PRIMARY HYPERTENSION- A RANDOMIZED COMPARATIVE OPEN CLINICAL TRIAL 
Trial Acronym  AVTAPMK 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Atul Chaudhari 
Designation  P G Scholar 
Affiliation  Parul Institute of Ayurved 
Address  OPD No 106 Department of Kayachikitsa Parul Ayurved Hospital Parul University AP Limda Tal Waghodia Vadodara Gujarat

Vadodara
GUJARAT
391760
India 
Phone  9113549691  
Fax    
Email  Atul11chaudhari@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Prakash A Kumbar 
Designation  Associate Professor  
Affiliation  Parul Institute of Ayurved 
Address  OPD No 106 Department of Kayachikitsa Parul Ayurved Hospital Parul University AP Limda Tal Waghodia Vadodara Gujarat

Vadodara
GUJARAT
391760
India 
Phone  6363202018  
Fax    
Email  drprakash.kc@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Atul Chaudhari 
Designation  P G Scholar 
Affiliation  Parul Institute of Ayurved 
Address  OPD No 106 Department of Kayachikitsa Parul Ayurved Hospital Parul University AP Limda Tal Waghodia Vadodara Gujarat

Vadodara
GUJARAT
391760
India 
Phone  9113549691  
Fax    
Email  Atul11chaudhari@gmail.com  
 
Source of Monetary or Material Support  
Parul institute of ayurved, Parul university 
 
Primary Sponsor  
Name  Dean Faculty of Ayurved Parul University 
Address  Parul University AP Limda Tal Waghodia Vadodara Gujarat 
Type of Sponsor  Private 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 Atul Chaudhari  Parul Institute of Ayurved  OPD No 106 Department of Kayachikitsa Parul Ayurved Hospital Parul University AP Limda Tal Waghodia Vadodara Gujarat
Vadodara
GUJARAT 		 9113549691

Atul11chaudhari@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
parul institute of ayurved-Institutional Ethics Committee for Human Research  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,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Aarogyavardhini vati 350mg 2 tab with Aaragwadha phala majja Ksheerpaka 30 ml After food BD for 1 month  Aarogyavardhini vati is an ayurvedic medicine having reference in Rasatantrasara and Sidhaprayoga Sangraha Pratham Khanda Swami shree krushnanandaji Maharaj. Krushna Gopal Ayurved bhavan Prakashan. It contains Parada(Mercury),Gandhaka(Sulphur),Loha(Iron),Abhraka(Mica),Tamra(Copper),Aamlaki(Emblica officinalis Gaertn),Haritaki(Terminalia chebula Retz),Vibhitaki(Terminalia bellirica Roxb),Shilajatu(Black Bitumen),Guggulu(Commiphora mukul),Chitraka(Plumbago zeylanica linn),Katuki(Picrorhiza kurroa Royle ex Benth),Nimba (Azadirachta indica A. Juss) The medicine will be given 350mg 2 tab with Aaragwadha phala majja Ksheerpaka 30 ml After food BD for 1 month  
Comparator Agent  ongoing antihypertensive medications  ongoing antihypertensive medications 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Age:- Patients of either sex between 20 and 65 years. (both years inclusive)
Diagnosed hypertension patients.
K/c/o hypertension with or without antihypertensive drugs.(With or without symptoms).
Patients with Stage 1 hypertension SBP(140–159)/DBP(90-99) mm of Hg & Stage 2 hypertension SBP(160–179)/DBP(100–109) mm of Hg.

 
 
ExclusionCriteria 
Details  Acute hemorrhagic condition, Acute septic shock
K/c/o hypertension history more than 12 years.
Hypertensive emergency i.e. blood pressure more than 180/120mm of Hg.
Secondary hypertension.
Pregnancy-induced hypertension.
Pregnant and lactating women.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Systolic blood pressure
Diastolic blood pressure
Mean Arterial pressure
 		 effect on Systolic blood pressure and Diastolic blood pressure and Mean Arterial pressure at baseline and at the end of 10 days till 1 month
 
 
Secondary Outcome  
Outcome  TimePoints 
Lipid profile  effect on Lipid profile at baseline and at the end of 10 days till 1 month 
 
Target Sample Size   Total Sample Size="63"
Sample Size from India="63" 
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 
Date of First Enrollment (India)   23/11/2020 
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   not yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Hypertension is called a ‘silent killer’. Most people with hypertension are unaware of the problem because it may have no warning signs or symptoms. It is chronic non communicable disease in which the pressure exerted by the blood on the  wall of the artery is elevated. It is classified as Primary Hypertension & Secondary hypertension. 
In Ayurveda there is no description of such a single disease which can resemble with hypertension. 
The global burden of HTN is anticipated to increase by 60% to affect approximately 29.2 % of adult population that accounts to 1.56 billion adults worldwide by 2025. The current therapeutic strategy involves use of various pharmacological agents like β blockers, ACE inhibitors, calcium channel blockers, α blockers and diuretics. However, use of these drugs is affected because various hindrances like side-effects and cost-effectiveness. These drugs help in altering the physiopathology and there are not going cure the disease.
This condition if remain untreated it further leads to cardiovascular disease, Renal disease, Vascular disease and advance hypertensive retinopathy etc. Hence, there is a strong need to search safe and cost-effective options for the management of hypertension considering metabolic disturbance. 
So Aarogyavardhini vati with Aaragwadha phala majja Ksheerpaka will be used in management of primary hypertension to see effectiveness of drug.

 
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