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A clinical trial to study the effect of Ayurvedic formulation in patients with Chronic Heart Failure

Clinical evaluation of T Ayu BKV in patients of Chronic Heart Failure with special reference to B type Natriuretic Peptide - CHF, BNP

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/07/014905
Enrollment
200
Registered
2018-07-17
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Chronic Heart Failure NYHA functional class

Interventions

Intervention1: T Ayu BKV - Tablet Ayurved Bhallatakadi Kshar Vati: Dose-125 mg Frequency- Twice along with food Route of administration-Oral Total duration-six months Control Intervention1: Placibo

Sponsors

Sri Sathya Sai Institute of Higher Medical Sciences Sri Sathya Sai Institute of Higher Learning
Lead Sponsor
Dr C S Hiremath DNB MCh
Collaborator
Dr P K Dash MD DM Cardiology
Collaborator
Dr Reeta Varyani MD DNB Cardiology
Collaborator
Dr Venketesh S PhD BioSciences
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: All patients on Conventional Heart Failure Therapy for at least six months. LVEF less than or equal to 40 percent with above criteria. NYHA functional class with above criteria. All above criteria and able to give written consent.

Exclusion criteria

Exclusion criteria: Valvular heart disease, Obstructive or restrictive Cardiomyopathy. Rheumatoid Heart Disease, Congenital Heart Disease. Myocarditis, myocardial infarction or cardiac surgery within the previous three months. Uncontrolled arrhythmias, uncontrolled hypertension, other non-cardiac high-risk underlying medical conditions,that require critical care including severe chronic obstructive pulmonary disease (COPD). Renal insufficiency. Administration of any other investigational drugs within the last 30 days before randomization. Under psychiatry treatment.

Design outcomes

Primary

MeasureTime frame
Changes in B type Natriuretic Peptide levels in both the arms from the baseline.Timepoint: Six months—

Secondary

MeasureTime frame
Changes in Minnesota living with heart failure questionnaire score in both the arms from baseline.Timepoint: Six months;Changes in ventricular dimensions through 2 D Echo-cardiogram screening from baseline.Timepoint: Six months;Metabolic homeostasisTimepoint: Six months;Six minute hall walk test- changes in distance walked in both the arms from the baselineTimepoint: Six months—

Countries

India

Contacts

Public ContactDr Sanghvi Bindiyaben Mukundbhai

Sri Sathya Sai Institute of Higher Medical Sciences

ayurvedsavitur@yahoo.co.in9326167845

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026