| CTRI Number |
CTRI/2024/08/073044 [Registered on: 28/08/2024] Trial Registered Prospectively |
| Last Modified On: |
24/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical study to compare the therapeutic efficacy of bark Psidium guajava and Terminalia arjuna on Hypertension |
|
Scientific Title of Study
|
A study on Psidium guajava L. (Parevata) and the therapeutic efficacy of its bark on Hypertension. |
| Trial Acronym |
HTNPG |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Posa Venkata Srikanth |
| Designation |
Post Graduate Scholar |
| Affiliation |
S.V. Ayurvedic College and Hospital |
| Address |
P.G. Department of Dravyaguna S.V.Ayurvedic
College and Hospital SVIMS CAMPUS, Tirupati.
ANDHRA PRADESH
517501
India
Chittoor
ANDHRA PRADESH
517501
India |
| Phone |
9491571915 |
| Fax |
|
| Email |
posasrikanth48@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S Pavan kumar |
| Designation |
Associate professor |
| Affiliation |
S. V. Ayurvedic College and Hospital |
| Address |
P.G Department of Dravyaguna, S.V. Ayurvedic College and
Hospital SVIMS CAMPUS, Tirupati.
Chittoor
ANDHRA PRADESH
517501
India
Chittoor
ANDHRA PRADESH
517501
India |
| Phone |
9493410914 |
| Fax |
|
| Email |
pavansangu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Posa Venkata Srikanth |
| Designation |
Post Graduate Scholar |
| Affiliation |
S. V. Ayurvedic College and Hospital |
| Address |
P.G. Department of Dravyaguna S.V. Ayurvedic
College and Hospital SVIMS CAMPUS, Tirupati.
ANDHRA PRADESH
517501
India
Chittoor
ANDHRA PRADESH
517501
India |
| Phone |
9491571915 |
| Fax |
|
| Email |
posasrikanth48@gmail.com |
|
|
Source of Monetary or Material Support
|
| S.V. Ayurvedic college and hospital SVIMS CAMPUS, Tirupati, Andhra Pradesh 517507 |
|
|
Primary Sponsor
|
| Name |
S.V. Ayurvedic college and hospital |
| Address |
SVIMS CAMPUS, Tirupati, Andhra Pradesh 517507 |
| 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 |
| Posa Venkata Srikanth |
S.V. Ayurvedic College and Hospital |
P.G. Department of
Dravyaguna, SVIMS
CAMPUS, Tirupati,
Andhra Pradesh
517507
Chittoor
ANDHRA PRADESH
Chittoor
ANDHRA PRADESH |
9491571915
posasrikanth48@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of TTDs S.V. Ayurvedic College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:I10||Essential (primary) hypertension. Ayurveda Condition: RAKTAVRUTAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Arjuna, Reference: Bhavaprakasha Nigantu, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 1 Months, anupAna/sahapAna: Yes(details: -Jala), Additional Information: - | | 2 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Parevata, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 1 Months, anupAna/sahapAna: Yes(details: -Jala), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Uncomplicated Primary Hypertension
Systolic Blood Pressure from above 130 mmHg to below 200 mmHg Diastolic Blood Pressure from above 85 mmHg to below 120 mmHg |
|
| ExclusionCriteria |
| Details |
Systolic Blood Pressure from below 130 mmHg to above 200 mmHg Diastolic Blood Pressure from below 85 mmHg to above 120 mmHg |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Patient get relief from Anxiety, Headache, Palpitations |
At baseline, 3rd week and 5th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Sweating,Sleeeplessness. |
At baseline, 3rd week and 5th week |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
05/09/2024 |
| 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="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
|
Hypertension it is a serious
medical condition and can increase the risk of Heart, Brain, Kidney and other diseases. It
is a major cause of premature death worldwide, with upwards of 1 in 4 men and 1 in 5
women – over a billion people – having the condition. The burden of Hypertension is felt
disproportionately in low and middle income countries, where two thirds of cases are
found, largely due to increased risk factors like Obesity, Lack of Physical Exercise,
Alcohol consumption, Smoking in recent decades. Hence for the present study the Efficacy of Psidium guajava L. bark is being studied in
cases of Hypertension in a comparative manner with that of Terminalia arjuna Roxb.
Bark, which will be considered as the standard drug. Hypertension is a condition where blood pressure increases and produces the
symptoms like Palpitations, Sleeplessness, Headache etc. These symptoms are
usually seen when there is a vitiation of VÄta, Pitta, Rakta doá¹£Äs as per the
Ä€yurvedic literature.
 To treat the condition Āyurveda suggests the use of drugs which are having the
properties of Há¹›dya and which can reduce the vitiation of VÄta, Pitta, Rakta doá¹£Äs.
ï‚· PÄrÄ“vata is one such drug which is mentioned in RÄja nighaṇá¹u having Há¹›dya
karma and also is useful to normalize the VÄta, Pitta, Rakta doá¹£Äs by virtue of its
Madhura vipÄka and Guru guṇa.
ï‚· PÄrÄ“vata is equated to Psidium guajava L. as per the literature. Present scientific
researchers also proved that various parts of Psidium guajava L. are being used as
a Cardioprotective agents.
ï‚· Stem bark of Psidium guajava L. contains Leucocyanidin which acts as
Cardioprotective. Luteic acids, Ellagic acid, Tannins, Sterols, Glycoside
Amritoside, Crystals of Calcium oxalates and Nitric oxide radicals have
antioxidant property which reduces oxidative stress and thus decreases the
generation of Reactive Oxygen Species (ROS) which has a key role in
pathophysiology of Hypertension and also improve endothelial and vascular
function which decreases the severity of blood pressure. Ellagic acid also has
Anti-proliferative property which could reduce the Cardio-vascular damage.
|