A study to check the safety and effectiveness of an integrated medicine called SHARP-veda as an additional treatment for coronary artery calcification.

Not Applicable

• Conditions: Health Condition 1: I708- Atherosclerosis of other arteries

• Registration Number: CTRI/2023/06/053568
• Lead Sponsor: Bhaktivedanta Hospital and Research Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 13 November 2023

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Patients with age criteria of 30 years and above.

2. All genders will be included in the study.

3. NYHA (New York Heart Association) Class-II

4. Chronic Stable Angina

5. Patients who are advised for CT angiography and with coronary artery and aortic CT scoring (combined score) of

greater than or equal to 10 and stenosis of score between 40-70 will be included in the study.

Exclusion Criteria

1. Unstable/Severe Angina

2. Symptomatic patients

3. Already experienced events such as ACS, MI

4. Heart failure with ejection fraction <40%

5. Estimated glomerular filtration rate <60 mL/min/1.73 m2.

6.White blood cell count <4000/mm3, haematocrit <32%, or platelet count <75000/mm3.

7.History of actual alcohol abuse or unwillingness to limit alcohol consumption to < 4 drinks per week.

8.Chronic use of oral steroid therapy or other immunosuppressive or biologic response modifiers.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate impact of integrated-SHARP veda therapy on coronary artery plaques’ stability, morphology and progression.Timepoint: The timepoints are 0, 3 and 6 months respectively.

Secondary Outcome Measures

Name	Time	Method
•To evaluate the impact of integrated-SHARP veda therapy on coronary arteries calcification based on calcium scoring. <br/ ><br>•To evaluate the impact of integrated-SHARP veda therapy on quality of life. <br/ ><br>•To evaluate clinical events occurring during the study period.Timepoint: The timepoints are 0, 3 and 6 months respectively.