Health Condition 1: I209- Angina pectoris, unspecified Health Condition 2: null- Male/Female patient with sign/symptoms of Angina Pectoris.
Conditions
Interventions
Control Intervention1: NIL: NIL
Sponsors
Care Lifescience Private Limited
Care Lifescience Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1 Patients with Normal Sinus Rhythm on ECG at Screening 2 Patients who have signed Written Informed Consent 3 Patients with stable/unstable or Prinzmetals angina for at least 3 months prior to inclusion (mild/moderate/severe) 4 Male or Female patients > 18 years and
Exclusion criteria
Exclusion criteria: 1 Male or Female patients 75 years of age 2 Congestive heart failure stage III or IV NYHA. 3 Symptomatic hypotension. 4 Atrial fibrillation, flutter, pacemaker or cardioverter-defibrillator implantation 5 History of serious abnormal drug reaction. 6 Patients with Postural hypotension 7 Patients with chronic kidney failure 8 History of any serious infectious disease like Hepatitis B or C, HIV etc. 9 History of severe psychiatric or behavioral disorders likely to interfere with the study. 10 Patients with other severe disease likely to interfere with the study in the investigators judgment. 11 Pregnant and lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Objective To assess efficacy of Tablet NGfenceTM by evaluating improvement in following parameter : 1) Frequency of anginal attack 2) Severity of anginal attack 3) Ability to perform physical activity Timepoint: At month 3 and month 6 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Objectives To assess tolerability of Tablet NGfenceTM by evaluating improvement in following parameter 1) Headache 2) Dizziness 3) Flushing 4) Vomiting 5) NauseaTimepoint: At month 03 and month 06 | — |
Countries
India
Contacts
Public ContactMr Nishant Upadhyay
4Care Lifescience Private Limited
Outcome results
None listed