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To test the efficacy of B P Care Tablets in patients having Hypertension.

An open Label, Single arm Clinical Study to Evaluate the efficacy of Shuddhi Dr. B P Care Tablets in patients having Hypertension. - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/08/092262
Enrollment
60
Registered
2025-08-04
Start date
Unknown
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

Health Condition 1: I119- Hypertensive heart disease withoutheart failure

Interventions

Intervention1: Shuddhi Dr. B P Tablets: Dose: 1-1 Tablet (BD) Route of Administration: Oral Duration : 1 day Control Intervention1: Not Applicable: Not Applicable

Sponsors

Jeena Sikho Lifecare Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Subject from 18-50 years of age. 2. Subject having BP range less than 180-120 or 100-109 will be eligible for enrollment. 3. Subjects that are able to give written informed consent in a manner approved by the institutional ethics committee and comply with the requirements of the study. 4. Subject willing to avoid participation in any other interventional clinical trial for the duration of the study.

Exclusion criteria

Exclusion criteria: 1. Have used, are using, or are planning to use immunosuppressive or immunomodulatory medication (i.e., biologics), including oral or parenteral corticosteroids. 2. Subject will not enroll with BP range higher than 180-120 or 100-109. 3. Subjects that have participated in any other interventional clinical trial in the previous 90 days. 4. Subjects with known sensitivity to any of the constituents of the investigational product. 5. Any clinically significant systemic or cutaneous disease, which may interfere with study treatment or procedures. 6. Chronic illness which may influence the outcome of the study. 7. Pregnant/nursing mothers

Design outcomes

Primary

MeasureTime frame
1. Reduction in BP calculated as Change in the Systolic and Diastolic Blood pressure Timepoint: At t0min, t30min, t1hs, t2hrs, t3hrs, t4hrs, t5hrs and t6hrs

Secondary

MeasureTime frame
1. Change in Heart Rate 2. Change in SGA (Subject Global Assessment) Score [0-3] such as Severe Headache, Chest pain, Difficulty breathing, Anxiety and Dizziness [t0min and t6hrs] Timepoint: At t0min, t30min, t1hrs, t2hrs, t3hrs, t5hrs and t6hrs

Countries

India

Contacts

Public ContactPuneet Mittal

CCFT Laboratories

puneetmittal@mgcts.org08937015757

Outcome results

None listed

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