| CTRI Number |
CTRI/2026/01/101068 [Registered on: 14/01/2026] Trial Registered Prospectively |
| Last Modified On: |
08/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Ayurvedic herbal Cap In High Blood Pressure Patients |
|
Scientific Title of Study
|
Randomized Controlled Clinical Study To Evaluate Add-On Effect of Polyherbal Ayurvedic Formulation (Cap.BPSolve) With Tab. Telmisartan In the Management Of Essential 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 |
Amruta Chandrakant Pacharne |
| Designation |
PG Scholar |
| Affiliation |
Siddhakala Ayurveda Mahavidyalaya , Sangmaner |
| Address |
OPD No 1 Kayachikitsa Department Siddhakala Ayurved mahavidyalaya pimp Arne road Sangma near Ahilyanagar Maharashtra 422605
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
8378819533 |
| Fax |
|
| Email |
amrutapachrne@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Satish Digambar Urhe |
| Designation |
Associate Professor in Kayachikitsa |
| Affiliation |
Siddhakala Ayurveda Mahavidyalaya , Sangmaner |
| Address |
OPD No 1 Kayachikitsa Department Siddhakala Ayurved mahavidyalaya pimparne road Sangma near Ahilyanagar Maharashtra 422605
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
9890035901 |
| Fax |
|
| Email |
drsatishurhe9@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Satish Digambar Urhe |
| Designation |
Associate Professor in Kayachikitsa |
| Affiliation |
Siddhakala Ayurveda Mahavidyalaya , Sangmaner |
| Address |
OPD No 1 Kayachikitsa Department Siddhakala Ayurved mahavidyalaya pimparne road Sangma near Ahilyanagar Maharashtra 422605
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
9890035901 |
| Fax |
|
| Email |
drsatishurhe9@gmail.com |
|
|
Source of Monetary or Material Support
|
| Siddhakala Ayurveda Mahavidyalaya ,Pimparne Road, Sangmaner Khurd, Sangmaner , Ahilyanagar, Maharashtra, India PIN code -422605 |
|
|
Primary Sponsor
|
| Name |
Amruta Chandrakant Pacharne |
| Address |
Siddhakala Ayurveda Mahavidyalaya ,Pimparne Road, Sangmaner Khurd, Sangmaner , Ahilyanagar, Maharashtra, India PIN code -422605 |
| Type of Sponsor |
Other [Self ] |
|
|
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 Amruta Chandrakant Pacharne |
Siddhakala Ayurved Mahavidyalaya And Hospital Sangamner |
OPD NO 1 Department of Kayachikista
Ahmadnagar
MAHARASHTRA |
8378819533
amrutapachrne@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Board Of Ayurved Research And Statistics Committee Of Siddhakala Ayurved Mahavidyalay , Sangamner |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:I10||Essential (primary) hypertension. Ayurveda Condition: VYANAVRUTAPRANAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Tab Telmisartan | Tab.Telmisartan 40mg OD Orally,with water,Morning before meal,for 15 days | | 2 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Capsule BPSolve, Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: Lukewarm water), Additional Information: Capsule BPSolve will prepared using 06 herbal drugs as per GMP guidelines and will use orally after pilot study. Cap BPSolve will be given along with Tab Telmisartan |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Systolic Blood Pressure: less than 170 mm of Hg more than or equal to 140 mm of Hg.
Diastolic Blood Pressure: less than or equal to 110 mm of Hg More
than 90 mm of Hg.
Patient willing to participate in the research & to sign the written
informed consent form. |
|
| ExclusionCriteria |
| Details |
Patient who has past history of atrial fibrillation, acute coronam syndrome, myocardial infarction, stroke or right ventricular hypertrophy, left ventricular hypertrophy, severe arrhythmia months.
Symptomatic patients with clinical features of early heart fai
Secondary hypertension.
Women who are pregnant and lactating or on estrogen rep therapy.
Alcoholics and drug abusers.
Accelerated and malignant hypertension. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Assess Add-on effect of Polyherbal Ayurvedic Formulation (Cap.BPSolve) with Tab. Telmisartan on Systolic blood pressure (SBP), Diastolic blood pressure(DBP), Heart rate (HR) in reduction of Essential Hypertension |
0th (baseline), 5 th , 10 th , 15 th day end of study with 5 days interval |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To Assess Add-on effect of Polyherbal Ayurvedic Formulation (Cap.BPSolve) with Tab. Telmisartan on other parameters like Headache, Giddiness, Fatigue, Palpitation, Insomnia etc. |
0th (baseline), 5 th , 10 th , 15 th day end of study with 5 days interval |
|
|
Target Sample Size
|
Total Sample Size="160"
Sample Size from India="160"
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)
|
31/01/2026 |
| 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)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
This Study is a Randomised open labelled controlled clinical trial to compare the efficacy and add on effect of 6 herbal Ayurvedic drug Formulation Cap BPSolve with Tab Telmisartan. This study is for 15 days in 160 Patients divided into 2 groups with Essential Hypertension and the effect on Systolic blood pressure ,Diastolic blood pressure, Heart-rate and other parameters like Headache, Fatigue ,Palpitation ,Insomnia , Giddiness etc |