| CTRI Number |
CTRI/2026/01/102121 [Registered on: 27/01/2026] Trial Registered Prospectively |
| Last Modified On: |
24/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Ayurvedic Medicine in High BP |
|
Scientific Title of Study
|
A Randomised standard controlled comparative clinical study to evaluate the adjuvant effect of Sarpagandha Mishrana along with conventional anti hypertensive therapy 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 |
Dr Biradar Varsha Ravikumar |
| Designation |
MD PG Scholar |
| Affiliation |
BLDEAS AVS Mahavidyala Hospital and research center |
| Address |
Department of Kayachikitsa OPD No. 4 BLDEAS AVS Mahavidyala Hospital and research center Bagalkot road Vidya nagar Vijayapura Karnatka 586109 India
Bijapur
KARNATAKA
586109
India |
| Phone |
8197603542 |
| Fax |
|
| Email |
biradarvarsha101@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjay Kadlimatti |
| Designation |
Professor department of Kayachikitsa |
| Affiliation |
BLDEAS AVS Mahavidyala Hospital and research center |
| Address |
Department of Kayachikitsa OPD No 4 BLDEAS AVS Mahavidyala Hospital and research center Bagalkot road Vidya nagar Vijayapura Karnatka 586109 India
Bijapur
KARNATAKA
586109
India |
| Phone |
8970744656 |
| Fax |
|
| Email |
ayursanjay@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjay Kadlimatti |
| Designation |
Professor department of Kayachikitsa |
| Affiliation |
BLDEAS AVS Mahavidyala Hospital and research center |
| Address |
Depatment of Kayachikitsa OPD No 4 BLDEAS AVS Mahavidyala Hospital and research center Bagalkot road Vidya nagar Vijayapura Karnatka 586109 India
Bijapur
KARNATAKA
586109
India |
| Phone |
8970744656 |
| Fax |
|
| Email |
ayursanjay@gmail.com |
|
|
Source of Monetary or Material Support
|
| BLDEAS AVS Ayurveda Mahavidyalaya Hospital and Research Center Bagalkota road Vidya nagar Vijayapura 586109 Karnataka India |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [] |
|
|
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 Biradar Varsha Ravikumar |
BLDEAS AVS Ayurveda Mahavidyalaya Hospital and Research center Vijayapura |
Department of Kayachikitsa oPD No 4 BLDEAS AVS Ayurveda Mahavidyalaya Hospital and Research center Bagalkot road vidyanagar Vijayapura Karnataka 586109
Bijapur
KARNATAKA |
8197603542
biradarvarsha101@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of BLDEAS Ayurveda Mahavidyala Hospital and Research center Vijayapura |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:I10||Essential (primary) hypertension. Ayurveda Condition: VYANAVATAKOPAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Sarpagandha Mishrana, Reference: The Ayurvedic Pharmacopoeia Of India, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: Usna Jala), Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Amlodipine | Amlodipine, Drug Class: Calcium channel blocker, Sub Class: Dihydropyridine calcium channel blocker, Route: Oral, Dosage: 5mg, Frequency: OD, Bheshaja Kala: Abhakta, Duration: 28 days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
79.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient taking Amlodipine but not achieving desired results are included.
2.Patients diagnosed as Essential Hypertension as per diagnostic criteria.
3.Subjects willing and able to participate in the study.
|
|
| ExclusionCriteria |
| Details |
1.Secondary Hypertension.
2.Patients with a prior diagnosis of severe or malignant hypertension, moderate hypertension associated with complications, cerebrovascular disorders, coronary artery diseases, kidney conditions, heart failure, cardiomyopathy, pre-eclampsia or eclampsia, diabetes mellitus, retinopathy, or any other coexisting physical or mental health condition.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| High Blood pressure reduction to normal range according to age |
28 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction of High blood pressure to normal range & maintenance blood pressure within normal range with medication |
28 days |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
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)
|
01/03/2026 |
| 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)
|
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
|
This study is a randomized standard controlled comparative clinical study to evaluate the adjuvant effect of Sarpagandha Mishrana along with conventional anti-hypertensive therapy in the managemnt of Essential Hypertension, that will be conducted in BLDEAS AVS Ayurveda Mahavidyala Hospital and Research Vijayapura 586109 Karnataka India |