| CTRI Number |
CTRI/2025/11/097050 [Registered on: 07/11/2025] Trial Registered Prospectively |
| Last Modified On: |
06/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical study on the effect of vanapalandu in improving heart function in patients with weak ejection fraction |
|
Scientific Title of Study
|
A clinical study on the effect of vanapalandu in kaphaja hridroga with special reference to low left ventricular ejection fraction A proof of concept study |
| 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 Falguni Joshi |
| Designation |
Phd scholar |
| Affiliation |
national institute of ayurveda |
| Address |
PG Department of Kayachikitsa National Institute of Kayachikitsa Jaipur
PG Department of Kayachikitsa National Institute of Kayachikitsa Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
07728953473 |
| Fax |
|
| Email |
hinadosi67@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Udai Raj Saroj |
| Designation |
Professor |
| Affiliation |
National Institute of Ayurveda, Jaipur |
| Address |
PG Department of kayachikitsa National Institute of Ayurveda Jaipur
PG Department of kayachikitsa National Institute of Ayurveda Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
9413063803 |
| Fax |
|
| Email |
ursarojayu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Udai Raj Saroj |
| Designation |
Professor |
| Affiliation |
National Institute of Ayurveda Jaipur |
| Address |
PG Department of Kayachikitsa National Institute of Ayurveda Jaipur
PG Department of Kayachikitsa National Institute of Ayurveda Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
9413063803 |
| Fax |
|
| Email |
ursarojayu@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Ayurveda Jaipur Rajasthan 302002 |
|
|
Primary Sponsor
|
| Name |
National Institute of Ayurveda Jaipur |
| Address |
National Institute of Ayurveda, Jaipur Rajasthan 302002 |
| Type of Sponsor |
Other [National Institute of Ayurveda Jaipur] |
|
|
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 Falguni Joshi |
NATIONAL INSTITUTE OF AYURVEDA |
PG DEPARTMENT OF KAYACHIKITSA NATIONAL INSTITUTE OF AYURVEDA DENOVO JAIPUR 302002
Jaipur
RAJASTHAN |
07728953473
hinadosi67@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC National institute of Ayurveda DENOVO Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:I501||Left ventricular failure, unspecified. Ayurveda Condition: KAPAJAHRUDROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Vanapalandu, Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 90(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: Luke warm water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
59.00 Year(s) |
| Gender |
Both |
| Details |
1. Adult patients of both genders, with stable HF (NYHA classification up to Class III and reduced EF not more than 40% and not less than 15%.
2. Patients who have already taken conventional therapy for more than or equal to 3 months and yet have the above criteria would also be included. |
|
| ExclusionCriteria |
| Details |
1.Patients with an Ejection Fraction of the Left Ventricle more than or equal to 40 percent and less than or equal to 15 percent will not
be included in the study.
2.Patients with a history of Unstable Angina, Acute Myocardial infarction (newly
diagnosed acute cases), valvular defects, congenital heart disease, pericarditis,
arrhythmia, Pericardial effusion, uncontrolled Hypertension (more than or equal to 150/90 mm Hg)
3.Patients with a history of extra Cardiac ailments like renal failure, uncontrolled
diabetes mellitus (HbA1c more than or equal to 8%) with or without complications, chronic alcoholics,
and pregnant/lactating women. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Change present in ejection fraction in 2D echocardiography of the heart after 2
months of trial. |
2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• Changes in signs and symptoms of Kaphaja Hridroga after 2 months of trial.
• Changes in symptoms using a standardized tool, the KCC Questionnaire after 2
months of trial.
• Frequency and severity of adverse effects documented during the intervention after
2 months of trial. |
2 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 |
|
Date of First Enrollment (India)
|
20/03/2026 |
| 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="0"
Months="4"
Days="15" |
|
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
|
A Clinical Study on the Effect of Vanapalandu in Kaphaja Hridroga with Special Reference to Low Left Ventricular Ejection Fraction: A Proof of Concept Study” this study Aims for improvement in reduced ejection fraction of heart by giving Vanapalandu 90mg twice a day for 60 days. outcomes are - improved ejection fraction assessing by 2D Echo by 60 days. |