| CTRI Number |
CTRI/2024/04/065952 [Registered on: 19/04/2024] Trial Registered Prospectively |
| Last Modified On: |
12/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Arjuna Twak Ksheerapaka and Cardio Tea in Pre Hypertension |
|
Scientific Title of Study
|
A Comparative Clinical Trial to Evaluate the Effect of Arjuna Twak Ksheerapaka and Cardio Tea in Pre 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 Sarvesh Kumar Agrawal |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Ayurveda |
| Address |
PG Department of Swasthavritta and Yoga National Institute of Ayurveda Jorawar Singh Gate Amber Road Jaipur Rajasthan
Jorawar Singh Gate Amber Road Jaipur Rajasthan 302002
Jaipur
RAJASTHAN
302002
India |
| Phone |
8058697177 |
| Fax |
|
| Email |
drsarvesh1008@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sarvesh Kumar Agrawal |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Ayurveda |
| Address |
Department of Swasthavritta and Yoga National Institute of Ayurveda Jorawar Singh Gate Amber Road Jaipur
Jorawar Singh Gate Amber Road Jaipur Rajasthan 302002
Jaipur
RAJASTHAN
DEEPAK SAINI
India |
| Phone |
8058697177 |
| Fax |
|
| Email |
drsarvesh1008@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neel Kamal Kishor |
| Designation |
Pg Scholar |
| Affiliation |
National Institute of Ayurveda Jaipur Rajasthan |
| Address |
Department of Swasthavritta and Yoga National Institute of Ayurveda Jorawar Singh Gate Amber Road Jaipur
Jorawar Singh Gate Amber Road Jaipur Rajasthan 302002
Jaipur
RAJASTHAN
302002
India |
| Phone |
8840710338 |
| Fax |
|
| Email |
neelkamal1415@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Ayurveda Jorawar Singh Gate Amber Road Jaipur Rajasthan 302002 |
|
|
Primary Sponsor
|
| Name |
National Institute of Ayurveda Jaipur |
| Address |
Jorawar Singh Gate Amber Road Jaipur Rajasthan 302002 |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Dr Neel Kamal Kishor |
OPD no 21 National Institute of Ayurveda |
Jorawar Singh Gate Amber Road Jaipur Rajasthan 302002
Jaipur
RAJASTHAN |
08840710338
neelkamal1415@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee National Institute of Ayurveda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:I10||Essential (primary) hypertension. Ayurveda Condition: HRUDROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: cardio tea , Reference: NA, Route: Oral, Dosage Form: Phanta, Dose: 100(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 12 Weeks, anupAna/sahapAna: No, Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Arjuna Twak Ksheerapaka, Reference: Bhaishajya Ratnavali shlok number 11 chapter number 33 Hrid rog chikitsa prakaran, Route: Oral, Dosage Form: Ksheerpaka, Dose: 100(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 12 Weeks, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Person between 30 to 70 years of age and irrespective of gender
Person Pre-hypertensive having BP 120 to 139 mm of Hg systolic and or 80 to 89 mm of Hg Diastolic
|
|
| ExclusionCriteria |
| Details |
Patients having any systemic and metabolic Diseases
Patient with comorbidity affecting mental or physical health
Abuse of drugs and alcohol addiction of tobacco
Pregnancy and lactation
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in Blood Pressure |
Baseline and every two weeks till 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in Lipid Profile cholesterol LDL HDL VLDL triglycerides |
12 weeks |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
15/05/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
15/04/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
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
|
Need of study: Pre-hypertension is one of the major
public health problems among NCDs in developing countries, which increases
cases of hypertension & chances of strokes from early ages.
Prevalence of
Pre-hypertension is significantly higher than hypertension. In India
about 23% are hypertensive while 38% are Pre-hypertensive.
•
There is no requirement
of medical intervention in pre-hypertension, the recommendations are only
lifestyle modification, still there is further chance of developing
hypertension.
•
The development of hypertension may be
prevented by controlling the condition of pre-hypertension by using Ayurvedic
management, Arjuna Twak Ksheerapaka or Cardio Tea in daily routine.
•
There are various evidences on the effect of Arjuna Twak
Ksheerapaka on hypertension.
•
Cardio Tea is a value-added version of Arjuna Twak
Ksheerapaka prepared by NIA (DU), Jaipur which includes Twak, Ela,
Shunthi and Mishreya along with Arjuna Twak to enhance the
palatability (taste and flavour).
Aim and Objectives
Aim: To evaluate the Effect of Arjuna Twak Ksheerapaka and Cardio Tea
in Pre-hypertension.
Objectives
Primary:
To compare
effect of Arjuna Twak Ksheerpaka and Cardio Tea in Pre-hypertension.
Secondary: To compare effect of Arjuna
Twak Ksheerapaka and Cardio Tea on
lipid profile.
Research Question
Primary: Is there any difference in
the effect of Arjuna Twak Ksheerapaka and Cardio Tea in
Pre-hypertension?
Secondary: Is there any difference
in the effect of Arjuna Twak Ksheerapaka
and Cardio Tea on lipid profile?
Null Hypothesis
H0 (1):There is no difference between the effect of Arjuna Twak Ksheerapaka and Cardio Tea in pre-hypertension.
H0 (2): There is no difference between the effect of Arjuna Twak
Ksheerapaka and Cardio Tea on lipid
profile.
Alternate Hypothesis (HA)
HA (1): There is Significant
difference between the effect of Arjuna Twak
Ksheerpaka and Cardio Tea in pre-hypertension.
HA(2): There is Significant
difference between the effect of Arjuna
Twak Ksheerapaka and Cardio Tea on
lipid profile. |