Efficacy of Cardojith in Adults with Stage 1 Hypertension

An Randomized Controlled Trial Assessing the Cardioprotective and Antihypertensive Potential of Cardojith in Adults with Stage 1 Hypertension - NIL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/11/098017

Enrollment

Registered

2025-11-25

Start date

Unknown

Completion date

Unknown

Last updated

2025-12-08

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

Conditions

Health Condition 1: I10- Essential (primary) hypertension

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: Patients aged 30 to 65 years with mild to moderate essential hypertension were enrolled in this study. Eligibility criteria included a mean sitting diastolic blood pressure greater than or equal to 80 mmHg and less than or equal to 89 mmHg and a mean sitting systolic blood pressure greater than or equal to 130 mmHg and less than or equal to 139 mmHg as measured prior to randomization.

Exclusion criteria

Exclusion criteria: Patients with secondary or malignant hypertension, structural or functional heart disease within the past six months, cerebrovascular disease within the past six months, uncontrolled diabetes defined as fasting blood glucose greater than 7.8 mmol per liter or glycosylated hemoglobin greater than 7.5 percent, malignant retinopathy, history of mental disorder, history of malignant tumor, alcohol or drug abuse, and those receiving concomitant medications with potential effects on blood pressure or antihypertensive drugs and statins

Design outcomes

Primary

Measure	Time frame
Change in mean sitting systolic blood pressure (msSBP) and mean sitting diastolic blood pressure (msDBP) from baseline to 8 weeks.Timepoint: Baseline, 2nd, 4th, 6th and 8th week.	—

Secondary

Measure	Time frame
Change in msSBP and msDBP from baseline to 2, 4, and 6 weeks of treatment.Timepoint: baseline to 2, 4, and 6 weeks of treatment;Response assessments after 4 and 8 weeks Marked response msDBP decreased by greater than or equal to 10 mmHg and within the normal range, OR msDBP decreased by greater than or equal to 20 mmHg but not within the normal range, OR msSBP decreased by greater than or equal to 30 mmHg. Response msDBP decreased by less than 10 mmHg and within the normal range, OR msDBP decreased by 10 19 mmHg but not within the normal range, OR msSBP decreased by greater than or equal to20 mmHg. Total response rate Sum of marked response rate and response rate. Timepoint: 4th and 8th weeks;Control rate after 4 and 8 weeks of treatment proportion of patients with msDBP less than 90 mmHg and msSBP less than 140 mmHg.Timepoint: 4th and 8th week;Reduction in perceived psychological stress, assessed using the Perceived Stress Scale (PSS) Timepoint: Baseline, 2nd, 4th, 6th and 8th week.;Decrease in high-sensitivity C-reactive protein (hs-CRP) levels Timepoint: Baseline, 2nd, 4th, 6th and 8th week.;Safety assessment through LFT, RFT and CBC; adverse events categorised according to CTCAE version 4.03 where study specific AE is defined with a severity of grade 3 or more and/or that leads to discontinuation of the study drug. Timepoint: 2nd, 4th, 6th and 8th week.	—

Measure

Time frame

Change in msSBP and msDBP from baseline to 2, 4, and 6 weeks of treatment.Timepoint: baseline to 2, 4, and 6 weeks of treatment;Response assessments after 4 and 8 weeks Marked response msDBP decreased by greater than or equal to 10 mmHg and within the normal range, OR msDBP decreased by greater than or equal to 20 mmHg but not within the normal range, OR msSBP decreased by greater than or equal to 30 mmHg. Response msDBP decreased by less than 10 mmHg and within the normal range, OR msDBP decreased by 10 19 mmHg but not within the normal range, OR msSBP decreased by greater than or equal to20 mmHg. Total response rate Sum of marked response rate and response rate. Timepoint: 4th and 8th weeks;Control rate after 4 and 8 weeks of treatment proportion of patients with msDBP less than 90 mmHg and msSBP less than 140 mmHg.Timepoint: 4th and 8th week;Reduction in perceived psychological stress, assessed using the Perceived Stress Scale (PSS) Timepoint: Baseline, 2nd, 4th, 6th and 8th week.;Decrease in high-sensitivity C-reactive protein (hs-CRP) levels Timepoint: Baseline, 2nd, 4th, 6th and 8th week.;Safety assessment through LFT, RFT and CBC; adverse events categorised according to CTCAE version 4.03 where study specific AE is defined with a severity of grade 3 or more and/or that leads to discontinuation of the study drug. Timepoint: 2nd, 4th, 6th and 8th week.

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Countries

India

Contacts

Public ContactDr Somit Kumar

The Arya Vaidya Pharmacy (Coimbatore) Limited

cso@avpresearch.org9003856200

Outcome results