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CTRI Number  CTRI/2020/10/028358 [Registered on: 12/10/2020] Trial Registered Prospectively
Last Modified On: 19/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparative Study of two Ayurvedic formulations in Hypertension 
Scientific Title of Study
Modification(s)  
COMPARATIVE EVALUATION OF THE EFFICACY OF DIVYA MUKTA VATI EXTRA POWER AND SARPAGANDHA VATI IN VYANA VAISHAMYA (ESSENTIAL HYPERTENSION) 
Secondary IDs if Any  
Secondary ID  Registry 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Gracy Sokiya 
Address  OPD no. 12 Department of Kayachikitsa Patanjali Ayurveda Hospital Haridwar
OPD no. 12 Department of Kayachikitsa Patanjali Ayurveda Hospital Haridwar
Hardwar
UTTARANCHAL
249405
India 
Phone  8949720684  
Fax    
Email  gsayurveda2017@gmail.com  
 
Details Contact Person
Scientific Query
 
Name  Dr Abhishek Bhushan Sharma 
Address  OPD no. 12 Department of Kayachikitsa Patanjali Ayurveda Hospital Haridwar
OPD no. 12 Department of Kayachikitsa Patanjali Ayurveda Hospital Haridwar
Hardwar
UTTARANCHAL
249405
India 
Phone  9458636020   
Fax    
Email  ayu.abhishek@gmail.com  
 
Details Contact Person
Public Query
 
Name  Dr Abhishek Bhushan Sharma 
Address  OPD no. 12 Department of Kayachikitsa Patanjali Ayurveda Hospital Haridwar
OPD no. 12 Department of Kayachikitsa Patanjali Ayurveda Hospital Haridwar
Hardwar
UTTARANCHAL
249405
India 
Phone  9458636020   
Fax    
Email  ayu.abhishek@gmail.com  
 
Source of Monetary or Material Support  
Patanjali Ayurveda Hospital Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan Haridwar  
 
Primary Sponsor  
Name  Patanjali Ayurveda College  
Address  Patanjali Ayurveda Hospital Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan Haridwar 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
Gracy Sokiya  OPD no. 12 Dept of kayachikitsa Patanjali Ayurveda Hospital Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan Haridwar 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Contact Person  Name of Site  Site Address  Phone/Fax/Email 
Gracy Sokiya  Patanjali Ayurveda Hospital  OPD no. 12 Department of Kayachikitsa Patanjali Ayurveda Hospital Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan Haridwar Hardwar UTTARANCHAL
Hardwar
 
08949720684

gsayurveda2017@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
PAC/IEC/2018-19/10  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Essential (primary) hypertension 
 
Intervention / Comparator Agent
Modification(s)  
Type  Name  Details 
Intervention  Group 1 with intervention of Mukta vati-extra power  2 tablets of Mukta vati-extra power with normal water will be given to the patients twice daily for 1 month 
Comparator Agent  Group 2 with Sarpagandha vati with anupaana of normal water will be given to patients.  2 tablets of Sarpagandha vati with normal water will be given to the patients twice daily for 1 month 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1.Patients between the age group of 18-50 years will be selected.
2.Patients having BP <159/95 and > 130/85 will be included.
3.Patients with symptoms of Vyana vaishamya and Essential HTN will be selected for the study.
4.Patients irrespective of sex, religion, occupation will be selected for the study.
5.Both fresh and treated cases would be taken for the study. 
 
ExclusionCriteria 
Details  1.Patients between the age group of 18-50 years will be selected.
2.Patients having BP <159/95 and > 130/85 will be included.
3.Patients with symptoms of Vyana vaishamya and Essential HTN will be selected for the study.
4.Patients irrespective of sex, religion, occupation will be selected for the study.
5.Both fresh and treated cases would be taken for the study. 
 
Method of Generating Random Sequence   Adaptive randomization, such as minimization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
TONOPORT-Ambulatory blood pressure monitoring will be done for 24 hours and examine:
1.Systolic blood pressure
2.Diastolic blood pressure
3.Mean blood pressure 
before intervention-
and during Follow up- After 7 days  
 
Secondary Outcome  
Outcome  TimePoints 
TONOPORT-Ambulatory blood pressure monitoring will be done for 24 hours and examine:
1.Systolic blood pressure
2.Diastolic blood pressure
3.Mean blood pressure 
after 15 days of treatment 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   14/10/2020 
Date of First Enrollment (Global)  No Date Specified 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details
Modification(s)  
An Ayurvedic Exploratory Study Of Vyana Vaishamya In Hypertension 
Brief Summary
Modification(s)  
Group-A-2 tablet BD of Divya Mukta vati-extra power will be given to patients
Group-B- 2 tablet BD of Sarpagandha vati will be given to patients

Both medicines will be advised to take 1 dose in morning at 9:00 a.m. after having breakfast and 2nd dose at 9:00 p.m.

Route of Administration- Oral

 Follow-Up: The follow up will be done after 7 days during the trial of 15 days to observe the effects of treatment or any adverse effects on the patient.


Final Result - Overall, it can be assessed on the basis of after treatment effect on subjective and objective parameters that Group A (Divya Mukta Vati - extra power) results were more significant as compared to Group B (Sarpagandha vati).
 

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