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

A prospective, comparative, single centre, proof-of-concept study to evaluate safety and efficacy of SHARP-veda as add on therapy to the standard of care in coronary artery calcification in comparison with control arm having standard of care.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/06/053568
Enrollment
60
Registered
2023-06-05
Start date
Unknown
Completion date
Unknown
Last updated
2023-11-13

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

Conditions

Health Condition 1: I708- Atherosclerosis of other arteries

Interventions

Intervention1: Nutraceutical-vitamin: 2 tablets per day for 6 months Intervention2: L arginine sachet: 2 tablets per day for 2 months Intervention3: nutraceutical: 1 tablet per day for 2 months Interv

Sponsors

Bhaktivedanta Hospital and Research Institute
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria: 1. Unstable/Severe Angina 2. Symptomatic patients 3. Already experienced events such as ACS, MI 4. Heart failure with ejection fraction 5. Estimated glomerular filtration rate 6. White blood cell count 7. History of actual alcohol abuse or unwillingness to limit alcohol consumption to 8. Chronic use of oral steroid therapy or other immunosuppressive or biologic response modifiers.

Design outcomes

Primary

MeasureTime frame
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

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

Countries

India

Contacts

Public ContactDr Dhaval Dalal

Bhaktivedanta Hospital and Research Institute

drsandeepkide@gmail.com9324929490

Outcome results

None listed

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