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A Study to see the number of heart patients using Ayurvedic medicines along with modern medicine and its long term effect

Not Applicable
Conditions
Health Condition 1: null- patients attending cardiology OPD IN AIIMS,NEW DELHI
Registration Number
CTRI/2018/04/013450
Lead Sponsor
Indian Council of Medical Research
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Open to Recruitment
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

Adult (18-70 years) Male / Female patients visiting the Cardiology OPD.

Participant willing to give informed consent and to come for follow up.

Patient with coronary artery disease with or without hypertension (stage I & stage II, systolic 140â??180 and diastolic 90â??110).

[American Heart Association]

Patient with left ventricular dysfunction with NYHA class I& II.

Patient taking Ayurvedic drug for any duration to assess the prevalence and taking Ayurvedic drug for the last 6 weeks to assess the effect.

Patient should be willing to continue the same drugs as used at the time of enrollment and for the whole follow up period after 6 months.

Exclusion Criteria

Patient already recruited for other trial.

Inability to comply with the protocol or not willing to give consent.

Pregnancy and lactation.

Patient suffering only with Hypertension or Hypertension with CVD with

(stage III, systolic >180 and diastolic >110)

Patient with NYHA class III &IV.

Past 3 months h/o or planned for re-vascularisation CABG/ PTCA in next 3 months.

Patient who has stopped Ayurvedic drug before follow up.

Patient with h/o unstable angina in last three months.

Patient taking Ayurvedic drug sine more than 6 weeks to assess the effect.

Other major organ dysfunction like renal dysfunction (Blood Urea >50 mg%, S.Creatinine >1.8 mg%) & hepatic dysfunction (AST/ ALT/ ALP/ Total S. Bilirubin > 3 times the upper normal limit )

With other co-morbid conditions like uncontrolled diabetes mellitus, hypertension and malignancy.

Any other condition which the investigator thinks may jeopardize the study.

Study & Design

Study Type
Observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
To assess the prevalence of the use of Ayurvedic drugs mentioned in Indian System of Medicine along with drugs of Modern medicine. <br/ ><br> <br/ ><br>To assess the effect Ayurvedic drugs used along with modern medicine on 6 minute walk test, Quality of Life (QOL) and other routine clinical parameters like blood pressure, Tread Mill Test and Echocardiography <br/ ><br>Timepoint: for prevelance part at base line and to assess effect at base line and after six months interval. <br/ ><br>
Secondary Outcome Measures
NameTimeMethod
changes in KCCQ SCORE,SAQ SCORE and Change in distance covered in 6Minute Walk Test.Timepoint: base line and 6 months
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