| CTRI Number |
CTRI/2025/01/079691 [Registered on: 29/01/2025] Trial Registered Prospectively |
| Last Modified On: |
27/01/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Anti hypertensive activity of polyherbal formulation |
|
Scientific Title of Study
|
Evaluation of the efficacy and safety of polyherbal formulation in mild to moderate hypertension : A randomized, double-blind, controlled clinical study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| BVG-HT-2 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kshipra Rajoria |
| Designation |
Assisstant Professor |
| Affiliation |
National Institute of Ayurveda Jaipur |
| Address |
Room no.113 A, Department of Panchakarma, National Institute of Ayurveda, Jorawar Singh Gate, Jaipur, India
Jaipur
RAJASTHAN
302002
India |
| Phone |
09001454100 |
| Fax |
|
| Email |
kshiprarajoria@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kshipra Rajoria |
| Designation |
Assisstant Professor |
| Affiliation |
National Institute of Ayurveda Jaipur |
| Address |
Room no.113 A, Department of Panchakarma, National Institute of Ayurveda, Jorawar Singh Gate, Jaipur, India
Jaipur
RAJASTHAN
302002
India |
| Phone |
09001454100 |
| Fax |
|
| Email |
kshiprarajoria@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sarvesh Kumar Singh |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Ayurveda Jaipur |
| Address |
Room no 116, Department of Panchakarma, National Institute of Ayurveda, Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
8739860237 |
| Fax |
|
| Email |
sarveshksingh21@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Ayurveda, Deemed to be University, Jorawar Singh Gate, Jaipur, Rajasthan, India,Pin-302002 |
|
|
Primary Sponsor
|
| Name |
BVG life sciences Limited |
| Address |
Sagar Complex, Nashik Phata, Opposite Kasarwadi Railway Station, Pune-411 034 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Kshipra Rajoria |
National Institute of Ayurveda |
Room no.113 A,Department of Panchakarma, National Institute of Ayurveda, Jorawar Singh Gate, Jaipur, India
Jaipur
RAJASTHAN |
09001454100
kshiprarajoria@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: PRANAVRUTAVYANAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Brahmi Vati, Reference: Ayurveda Sara Sangraha, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 12 Weeks, anupAna/sahapAna: No, Additional Information: -Brahmi Vati will be provided in capsule form | | 2 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: BVGC20/1, Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 600(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 12 Weeks, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Stage 1 Essential hypertension (average automated systolic blood pressure of 140 to 160 mmHg or diastolic blood pressure of 90 to 100 mm of Hg acc. to JNC VIII) |
|
| ExclusionCriteria |
| Details |
1. Atrial Fibrillation (AF)/ Sick Sinus Syndrome (SSS)/ atrioventricular block 2-3 grade without pacemaker.
2. Bradyarrhythmia
3. Unstable Angina Pectoris (UAP)/AMI/ HF (NYHA class III - IV)
4. Uncontrolled diabetes mellitus (DM)
5. Gastro-intestinal ulcer
6. Liver dysfunction/ renal impairment
7. Treated with CCB (Calcium antagonists) or other beta blocker.
8. Pregnant or lactating women
9. Legal incapacity or limited legal capacity |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Percentage of patients achieving blood pressure (B.P) less than 140/ 90 mm of Hg |
Baseline and at 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in Systolic blood pressure, diastolic blood pressure, mean arterial pressure |
baseline to 12 weeks |
| Safety will be assessed by recording adverse events (through 24 hours post-dose and at all follow-ups) and physical examination and vitals (Baseline to 12 weeks) along with the evaluation of LFT, and KFT. |
baseline to 12 weeks |
| Assessment of change in the proportion of subjects with reduced doses of conventional treatment from screening to end of the study |
baseline to 12 weeks |
| Change in eGFR (estimated glomerular filtration rate) |
baseline to 12 weeks |
| Changes in Blood sugar levels, Lipid profile, BMI, Waist circumference of the patients and the Psychological and somatic wellbeing on the basis of Hamilton anxiety rating scale. |
baseline to 12 weeks |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 3 |
|
Date of First Enrollment (India)
|
07/02/2025 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
It will be a 12-week interventional study with 60 participants with stage 1 essential hypertension. The participants will be randomly assigned equally in two arms. One group will receive Brahmi capsules, while the other group will receive a test drug. The efficacy and safety of both treatments will be compared. Efficacy will be evaluated based on the percentage of subjects achieving B.P. less than 140/90 mm of Hg, as well as changes in systolic blood pressure (SBP), diastolic blood pressure (DBP), and mean arterial pressure (MAP) from baseline to the end of the12 weeks. Safety will be assessed by recording adverse events from the baseline to the end of the 12-week study. |