| CTRI Number |
CTRI/2025/07/091868 [Registered on: 28/07/2025] Trial Registered Prospectively |
| Last Modified On: |
28/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Ayurveda
Nutraceutical
Other (Specify) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Efficacy of B P Care Tablets in patients having Hypertension |
|
Scientific Title of Study
|
An open Label, Single arm Clinical Study to Evaluate the efficacy of Shuddhi Dr. B P Care Tablets in patients having Hypertension |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MGCTS/25/737 Version 1.0 dated 12 Mar2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mansoor Riyaz |
| Designation |
Principal Investigator |
| Affiliation |
CCFT Laboratories |
| Address |
1st Floor room 3, Skin testing lab , CCFT laboratories, AR
multispecialty hospital and research center, Delhi Road
Meerut
UTTAR PRADESH
250005
India |
| Phone |
9760176786 |
| Fax |
|
| Email |
mansoor25riyaz@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Puneet Mittal |
| Designation |
Clinical Research Consultant |
| Affiliation |
CCFT Laboratories |
| Address |
1st Floor room 3, Skin testing lab , CCFT laboratories, AR
multispecialty hospital and research center, Delhi Road
Meerut
UTTAR PRADESH
250005
India |
| Phone |
8937015757 |
| Fax |
|
| Email |
puneetmittal@mgcts.org |
|
Details of Contact Person
Public Query
|
| Name |
Puneet Mittal |
| Designation |
Clinical Research Consultant |
| Affiliation |
CCFT Laboratories |
| Address |
1st Floor room 3, Skin testing lab , CCFT laboratories, AR
multispecialty hospital and research center, Delhi Road
Meerut
UTTAR PRADESH
250005
India |
| Phone |
8937015757 |
| Fax |
|
| Email |
puneetmittal@mgcts.org |
|
|
Source of Monetary or Material Support
|
| CCFT Laboratories
laboratories, AR multispecialty hospital and research center, Delhi Road |
| Jeena Sikho Lifecare Limited, Kalgidhar Enclave, Baltana, Zirakpur,, Mohali Punjab
140604 |
|
|
Primary Sponsor
|
| Name |
Jeena Sikho Lifecare Limited |
| Address |
Kalgidhar Enclave, Baltana, Zirakpur,, Mohali Punjab
140604 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Not Applicable |
Not Applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mansoor Riyaz |
CCFT laboratories |
1st Floor room 3, Skin
testing lab , CCFT
laboratories, AR
multispecialty hospital
and research center,
Delhi Road
Meerut
UTTAR PRADESH |
9760176786
mansoor25riyaz@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ARMHRC Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I10||Essential (primary) hypertension, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
Test Product: Shuddhi Dr. B P Care Tablets |
Test Product: Shuddhi Dr. B P Care Tablets
Dose: 1 tablet
Route of Administration: Oral
Druation: 6 hrs
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
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.
|
|
| ExclusionCriteria |
| Details |
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.
• Subjects that have participated in any other interventional clinical trial in the previous 90 days.
3. Subjects with known sensitivity to any of the constituents of the investigational product.
4. Any clinically significant systemic or cutaneous disease, which may interfere with study treatment or procedures.
5. Chronic illness which may influence the outcome of the study.
6. Pregnant/nursing mothers
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Change in the Systolic and Diastolic Blood pressure
2. Change in Heart rate
3. Change in SGA |
Time Frame- 0 min and 30 min, 1hr, 2hr, 3hr, 4hr, 5hr, 6hr |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not Applicable |
Not Applicable |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
08/08/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="7" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
An Open Label, Single arm clinical study. Patients will be assigned to investigational product for 6hrs, following up on T30min, T1hr, T2hr, T3hr, T4hr, 5hr, T6hr. On day 1, Blood pressure is monitored at T0min(Pre), and post T30min, T1hr, T2hr, T3hr, T4hr, 5hr, T6hr to check the instant action of the investigational Product. Subjects will be enrolled based on their Systolic and diastolic range.
The Asessments will be done on different timestamps are- Subject Global
Assessment, Blood Pressure Measurement and Heart Rate |