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CTRI Number  CTRI/2024/02/062842 [Registered on: 19/02/2024] Trial Registered Prospectively
Last Modified On: 16/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Role of Yoga 2 tablets in the patients with essential hypertension 
Scientific Title of Study   A Randomized Comparative Open Labelled Clinical evaluation of Tablet Yoga 2 in management of essential hypertension. 
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 Dipeeka Surwase 
Designation  Ph D Scholar 
Affiliation  Parul Institute of Ayurved 
Address  Opd No 116 Kayachikitsa Department Parul Ayurved Hospital Parul University PO Limda Tal Waghodia Vadodara

Vadodara
GUJARAT
391760
India 
Phone  9860750957  
Fax    
Email  drdipeeka77@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Naresh Kore 
Designation  Professor 
Affiliation  Parul Institute of Ayurved and Research 
Address  Opd No 8 Kayachikitsa Department Khemdas Ayurved Hospital Parul Institute of Ayurvved and Research Parul University PO Ishwarpura Tal Waghodia Vadodara

Vadodara
GUJARAT
391760
India 
Phone  8275174623  
Fax    
Email  naresh.kore86275@paruluniversity.ac.in  
 
Details of Contact Person
Public Query  
Name  Dr Naresh Kore 
Designation  Professor 
Affiliation  Parul Institute of Ayurved and Research 
Address  Opd No 8 Kayachikitsa Department Khemdas Ayurved Hospital Parul Institute of Ayurvved and Research Parul University PO Ishwarpura Tal Waghodia Vadodara

Vadodara
GUJARAT
391760
India 
Phone  8275174623  
Fax    
Email  naresh.kore86275@paruluniversity.ac.in  
 
Source of Monetary or Material Support  
OPD NO 16 Department Kayachikitsa Parul Institute Of Ayurved P O Limda Waghodia Vadodara Gujarat 391760 
 
Primary Sponsor  
Name  Dean and Principal Faculty of Parul Institute ofAyurved 
Address  Parul Institute of Ayurved Parul University Limda Gujarat 
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 Dipeeka Surwase  Parul Ayurved Hopsital  OPD NO 116 Department of kayachikitsa Parul Institue of ayurved Parul University Vadodara Gujarat
Vadodara
GUJARAT 		 9860750957

drdipeeka77@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Parul Institute of Ayurved Parul University.  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: VYANAVATAKOPAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugOther than Classical(1) Medicine Name: Tablet Yoga 2, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 1000(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: water), Additional Information: -
2Comparator Arm (Non Ayurveda)-Allopathic Antihypertnsive medicineAny Antihypertensive medicine prescribed by registered allopathic physician.
3Comparator ArmDrugOther than Classical(1) Medicine Name: Tablet Yoga 2 along with ongoing allopathy medicine ., Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 1000(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: water), Additional Information: -
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Newly Diagnosed hypertension patients
2.Known case of hypertension with or without antihypertensive drugs
3.Patients of either sex between 20 and 65 years of age
4.Patients with stage 1 hypertension with the systolic blood pressure of 140 to 159 and diastolic blood pressure of 90 to 99 mm of Hg
Stage 2 hypertension with the systolic blood pressure from 160 to 179 and diastolic blood pressure of 100 to 109 mm of Hg

 
 
ExclusionCriteria 
Details  1.Acute haemorrhagic condition and Acute septic shock
2.Known case of hypertension history more than 12 years
3.Hypertensive emergency that is blood pressure more than 180 and 120 mm of Hg
Secondary hypertension
Pregnancy induced hypertension
Pregnant and lactating women
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To obtain systolic and diastolic blood pressure at normal level in hypertensive patient.  3 months 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in lipid metabolism along with increase quality of life & complication of disease reduce.   After 3 months 
 
Target Sample Size   Total Sample Size="204"
Sample Size from India="204" 
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 
Date of First Enrollment (India)   28/02/2024 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 - NO
Brief Summary  

Aim : To Study antihypertensive effect of Tablet Yoga 2.

Objective:  1. To evaluate anti hypertensive efficacy of Tablet Yoga 2 in reducing blood pressure levels, both systolic and diastolic measurements.

2. To determine the effect of Tablet Yoga 2 in the integrated management of ETHN based on the reduction/discontinuation of medications of standard care.

 Need of Study:

Ø Hypertension – or elevated blood pressure is a serious medical condition that significantly increases the risks of heart, brain, Kidney and other diseases.

Ø An estimated 1.28 billion adults aged 30-79 years worldwide have hypertension, most living  in low and middle income countries.

Ø An estimated 46% of adults with hypertension are unaware that they have the condition.

Limitation in Current Antihypertensive Management :

1.    Most of People ignore early signs of Hypertensition.

2.    Due dependency of Coventional medical treatment, integrated approach will be better.

3.    Cost effective treatment is needed.

 
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