| CTRI Number |
CTRI/2014/10/005085 [Registered on: 08/10/2014] Trial Registered Retrospectively |
| Last Modified On: |
02/10/2014 |
| 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
|
AN EFFECT OF JATAMANSYADI VATI IN ESSENTIAL HYPERTENSION |
|
Scientific Title of Study
|
A STUDY ON VYANABALA VRIDDHI (ESSENTIAL HYPERTENSION) AND ITS MANAGEMENT WITH JATAMANSYADI VATI |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shreyas Rajeshkumar Adhvaryu |
| Designation |
MD scholar |
| Affiliation |
Institute for Post Graduate Teaching And Research in Ayurveda |
| Address |
Department of Kayachikitsa Institute for Post Graduate Teaching And Research in Ayurveda Gujarat Ayurved University Jamnagar Gujarat India
Shivdham Luhar Falia Bardoli Dist Surat Gujarat India
Jamnagar
GUJARAT
361008
India |
| Phone |
9913063278 |
| Fax |
|
| Email |
shreyasadhvaryu@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr A R Dave |
| Designation |
Associate Professor |
| Affiliation |
Institute for Post Graduate Teaching And Research in Ayurveda |
| Address |
Department of Kayachikitsa Institute for Post Graduate Teaching And Research in Ayurveda Gujarat Ayurved University Jamnagar Gujarat India
Jamnagar
GUJARAT
361008
India |
| Phone |
9824171817 |
| Fax |
|
| Email |
alankruta@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr A R Dave |
| Designation |
Associate Professor |
| Affiliation |
Institute for Post Graduate Teaching And Research in Ayurveda |
| Address |
Department of Kayachikitsa Institute for Post Graduate Teaching And Research in Ayurveda Gujarat Ayurved University Jamnagar Gujarat India
GUJARAT
361008
India |
| Phone |
9824171817 |
| Fax |
|
| Email |
alankruta@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Institute for Post Graduate Teaching And Research In Ayurveda Gujarat Ayurved University Jamnagar 361008 |
|
|
Primary Sponsor
|
| Name |
Institute for Post Graduate Teaching And Research in Ayurveda |
| Address |
Institute for Post Graduate Teaching And Research in Ayurveda Gujarat Ayurved University Jamnagar Gujarat 361008 India |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Shreyas Rajeshkumar Adhvaryu |
OPD Department of Kayachikitsa |
Institute for Post Graduate Teaching And Research in Ayurveda Gujarat Ayurved University Jamnagar 361008 India
Jamnagar
GUJARAT |
9913063278
shreyasadhvaryu@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional ethics committee IPGT and RA |
Approved |
| Institutional ethics committee ipgt and ra |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Vyanabala Vriddhi, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Jatamansyadi Vati |
Jatamansyadi Vati 1 gm BD after meal for duration of 28 days |
| Comparator Agent |
Metoprolol |
Metoprolol 25 or 50 mg OD for duration of 28 days |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients above 25 years and below 65 years of age will be selected for the study
Patients with systolic blood pressure above 140 mm of Hg and below 180 mm of Hg will be taken for the study
Patients with diastolic blood pressure above 90 mm of Hg and below 110 mm of Hg will be taken for the study
Patients presenting with the classical symptoms of Hypertension will be taken for the study
|
|
| ExclusionCriteria |
| Details |
Patients below 25 years and above 65 years of age will be excluded from the study
Patients with systolic blood pressure below 140 mm of Hg and above 180 mm of Hg will be excluded from the study
Patients with diastolic blood pressure below 90 mm of Hg and above 110 mm of Hg will be excluded from the study
Patients having major illness like severe D.M., tuberculosis, major endocrine disorders, malignancies, HIV, renal failure will be excluded from the study
Patients having accelerated and malignant hypertension and history of cardiac compromise like angina, MI, CCF will also be excluded
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| control of hypertension |
28 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| improve quality of life |
after 28 days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
07/04/2014 |
| 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) |
Open to Recruitment |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a randomized control clinical trial at I P G T and R A, Gujarat Ayurved University, Jamnagar in Department of Kayachikitsa OPD. Dealing with treatment of Vyanabala Vriddhi (essential hypertension). In present study Jatamansyadi Vati which contain Jatamansi, Ashwagandha, Arjuna, Gokshura and Brahmi in equal parts will be given 1 gm BD for 28 days as interventional group. In control group Metoprolol will be given 25 mg or 50 mg OD for 28 days.
|