| CTRI Number |
CTRI/2025/04/084330 [Registered on: 07/04/2025] Trial Registered Prospectively |
| Last Modified On: |
03/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Ayurvedic drug formulation on blood pressure. |
|
Scientific Title of Study
|
A randomized, double-blind, clinical study to assess safety and efficacy of polyherbal formulation in mild to moderate hypertension |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| PALS-HT-2 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kshipra Rajoria |
| Designation |
Assistant Professor |
| Affiliation |
National Institute of Ayurveda Jaipur |
| Address |
Room no.113 A, Department of Panchakarma, National institute of Ayurveda, Jorawar Singh Gate, Jaipur, Rajasthan, India.
Jaipur
RAJASTHAN
302002
India |
| Phone |
9001454100 |
| Fax |
|
| Email |
kshiprarajoria@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kshipra Rajoria |
| Designation |
Assistant Professor |
| Affiliation |
National Institute of Ayurveda Jaipur |
| Address |
Room no.113 A, Department of Panchakarma, National institute of Ayurveda, Jorawar Singh Gate, Jaipur, Rajasthan, India.
Jaipur
RAJASTHAN
302002
India |
| Phone |
9001454100 |
| 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 |
PALS Limited |
| Address |
PALS Limited, A1-301, Wonderwall, Concord Portia Lane, Balewadi, N, Pune-411 045
|
| 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, Jorawar Singh Gate, Jaipur, Rajasthan, India.
Jaipur
RAJASTHAN |
09001454100
kshiprarajoria@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
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. Vattiprakarana, Published by Shri Baidyanath Ayurveda Bhavana Limited, Nani, Allahabad. 2010.p.455, 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: PAYUBP, Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 400(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 |
1. 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)
2. 18 to 65-years-old Male or female and able to provide informed consent.
|
|
| 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 another 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 |
| Assessment of changes in systolic and diastolic blood pressure |
Baseline to 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in eGFR (estimated glomerular filtration rate). |
baseline to 12 weeks.
|
| Assessment of change in anthropometric parameters like BMI, BMR, Waist and hip circumference. |
baseline to 12 weeks. |
| Assessment of change in improvement in quality of life health survey score |
baseline to 12 weeks.
|
The safety of the intervention will be assessed by evaluating:
Laboratory parameters of renal function test. |
baseline to 12 weeks.
|
| Adverse events profile from baseline to end of the study. |
baseline to 12 weeks.
|
| Compliance and tolerability of the investigational product throughout the study |
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)
|
15/04/2025 |
| 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 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
|
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 vati in capsule form, 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 lab values of RFT, and adverse events from the baseline to the end of the 12-week study.
|