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CTRI Number  CTRI/2020/04/024899 [Registered on: 28/04/2020] Trial Registered Prospectively
Last Modified On: 03/06/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of ayurveda formulation and nidana parivarjana in the management of uccharaktachapa(hypertension) 
Scientific Title of Study   A clinical study of an Ayurvedic formulation with and without Nidana Parivarjana in the management of Vyanabala Vaishamya w.s.r. to primary hypertension 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Kusum Verma 
Designation  PG scholar 
Affiliation  National Institute of Ayurveda Jaipur 
Address  P.G. Dept. of Kayachikitsa National Institute of Ayurveda Jaipur

Jaipur
RAJASTHAN
302002
India 
Phone  9887888070  
Fax    
Email  drkusumverma38@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Udai Raj Saroj  
Designation  Associate Professor 
Affiliation  National Institute of Ayurveda Jaipur 
Address  P.G. Dept. of Kayachikitsa National Institute of Ayurveda Jaipur

Jaipur
RAJASTHAN
302002
India 
Phone  9983341119  
Fax    
Email  ursarojayu@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Kusum Verma 
Designation  PG scholar 
Affiliation  National Institute of Ayurveda Jaipur 
Address  P.G. Dept. of Kayachikitsa National Institute of Ayurveda Jaipur

Jaipur
RAJASTHAN
302002
India 
Phone  9887888070  
Fax    
Email  drkusumverma38@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Ayurveda Madhav Vilas Palace Amer Road Jaipur Rajasthan 
 
Primary Sponsor  
Name  National Institute of Ayurveda Jaipur 
Address  Madhav Vilas Palace Amer Road Jaipur302002 
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 Kusum Verma  National Institute of Ayurveda Hospital Jaipur  OPD No 1, 7, 18, 25 Dept. of Kayachikitsa, Madhav Vilas Palace Amer Road Jaipur, 302002 Jaipur RAJASTHAN
Jaipur
RAJASTHAN 		 9079204229

drkusumverma38@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE OF NATIONAL OF AYURVEDA JAIPUR  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  Ayurvedic formulation  25 well diagnosed patients of vyanabala vaishamya (Primary HTN) will be administered Ayurvedic Formulation 2capsule (500mg each) twice a day with lukewarm water before meal for 30 days. 
Intervention  Nidana parivarjana  25 well diagnosed patients of vyanabala vaishamya (Primary HTN) will be administered Ayurvedic Formulation 2capsule (500mg each) twice a day with lukewarm water before meal with Nidana parivarjana for 30 days. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  59.00 Year(s)
Gender  Both 
Details  1. Patients willing to sign the consent form for the clinical trial.
2. Patients belonging to either sex between the age group 18 to 59 years.
3. Patients having no known complication of disease.
4. Diagnosed case of stage-1 (Systolic B.P 140 to 159, Diastolic B.P 90 to 99 mm of Hg) would be selected for study (as per 8thJNC). 
 
ExclusionCriteria 
Details  1. Patients having secondary hypertension.
2. Patents having systemic/serious complications of Cardiovascular / Cerebrovascular / Renal system.
3. Pregnant patients.
4. Patients on Oral Contraceptive Pills.
5. History of liver disease in the recent past.
6. Hypertensive-Retinopathy
7. Patients who have completed participation in any other clinical trial drugs or their ingredients within one month period.
8. Patients who have received any Antihypertensive medication (Modern Drug) within last two weeks.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Changes in Systolic and Diastolic Blood Pressure.  31 days 
 
Secondary Outcome  
Outcome  TimePoints 
Changes in Qualitative and Quantitative variables (Except Systolic and Diastolic Blood Pressure and ECG)  31 days 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)
Modification(s)  		 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   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Hypertension is a common lifestyle disorder and is a very strong risk factor for cardiovascular diseases(CVDs). It is estimated that it increase the risk at least two fold for CVDs including coronary artery diseases(CAD).

Therefore to attain and to maintain good health, hypertensive patients are looking towards Ayurveda. So it has become an important duty of Ayurvedic research scholars and physicians to study the theory of hypertension and to check out its proper mode of treatment.

AIM OF STUDY:

1.      To study the effect of an Ayurvedic Formulation with and without nidana parivarjana in the management of vyanabala vaishamya w.s.r. to primary hypertension.

OBJECTIVE OF STUDY:

1.      To study the etiopathogenesis, symptomatology of primary hypertension on the basis of                     

     Ayurvedic principles.

Null hypothesis [Ho]:

·         Trial drug (Ayurvedic Formulation) is equally effective with Nidana parivarjana than without Nidana parivarjana in the management of vyanabala vaishamya w.s.r. to primary hypertension.

Alternative hypothesis [H1]:

·         There will be no difference between the effect of trial drug (Ayurvedic formulation) with Nidana parivarjana than without Nidana parivarjana in the management of vyanabala vaishamya w.s.r. to primary hypertension.


 
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