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A comparative clinical trial to study the effects of two ayurvedic medicines, simple distillation of plant Prishniparni and Chitraka haritaki rasayana along modern treatment in patients of Chronic Heart Failure.

Phase 2
Conditions
Health Condition 1: I501- Left ventricular failure, unspecified
Registration Number
CTRI/2024/03/064622
Lead Sponsor
All India Institute of Ayurveda
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

1.Age: above 21 years and below 60years.

2.Gender: both male and female

3.Diagnosed case of CHF: NYHA function classification II - III/ Stage C HF – according to AHA

4.LVEF <30 % - measured by a two-dimensional echocardiogram.

5.Raised Pro-BNP (above normal for the given age)

6.Willingness for participation in the study

Exclusion Criteria

1.Primary organic valvular disease and severe CAD needs surgical intervention.

2.Pulmonary hypertension (PAP > 25mmHg)

3.History of CABG - PTCA - PCI or any other cardiac surgical intervention.

4.Patients having active infective cardiac disease

5.Any evidence of thrombo-embolic heart disease or peripheral arterial disease (Ankle-Brachial index >1.4)

6.Any history of CVA - TIA - DVT or pulmonary embolism in the past 6 months.

7.Pregnant or lactating women.

8.non-willingness to take Ayurvedic medicine.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
•Changes in Cardiac Biomarker & Ventricular Ejection Fraction <br/ ><br>Timepoint: day 1 day 75
Secondary Outcome Measures
NameTimeMethod
•Exercise tolerance capacity (6minute walking distance change - 6MWT) <br/ ><br>•Changes in Cardiac Function Grading (New York Cardiac Function Grading NYHA) <br/ ><br>•Changes in health-related quality of life (CHF related quality of life) <br/ ><br>Timepoint: day 1 <br/ ><br>day 15 <br/ ><br>day 30 <br/ ><br>day 45 <br/ ><br>day 60 <br/ ><br>day 75
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