| CTRI Number |
CTRI/2021/05/033481 [Registered on: 07/05/2021] Trial Registered Prospectively |
| Last Modified On: |
11/12/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Treatment of Essential Hypertension Grade 2 with a Unani formulation |
|
Scientific Title of Study
|
A Clinical Study on the Management of Essential Hypertension Grade 2 (Zaghtuddam Qawi Ibtidai- Darja Doem)with A Polyherbal Unani Formulation, A Randomized Standard Controlled Clinical Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof Rais Ur Rahman |
| Designation |
Head department of Moalijat |
| Affiliation |
Ayurvedic and Unani Tibbia College and Hospital |
| Address |
First floor CR park New Delhi
Karol Bagh New Delhi
Central
DELHI
110019
India |
| Phone |
9313980776 |
| Fax |
-- |
| Email |
drrahman002@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Rais Ur Rahman |
| Designation |
Head department of Moalijat |
| Affiliation |
Ayurvedic and Unani Tibbia College and Hospital |
| Address |
First floor CR park New Delhi
Karol Bagh New Delhi
Central
DELHI
110019
India |
| Phone |
9313980776 |
| Fax |
-- |
| Email |
drrahman002@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nazneen Aiman Siddiqui |
| Designation |
P G Scholar |
| Affiliation |
Ayurvedic and Unani Tibbia College and Hospital |
| Address |
A and U Tibbia College
Jamia Nagar Okhla
South
DELHI
110005
India |
| Phone |
6395258760 |
| Fax |
-- |
| Email |
aimansiddiqui14@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ayurvedic and Unani Tibbia College and Hospital Karol Bagh New Delhi |
|
|
Primary Sponsor
|
| Name |
Prof Rais Ur Rahman |
| Address |
Ayurvedic and Unani Tibbia College and hospital |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Prof Rais ur Rahman |
Ayurvedic and Unani Tibbia College and Hospital |
Room number 4 Moalijat OPD Ajmal Khan Road Karol Bagh New Delhi 05
Central
DELHI |
9313980776
-
drrahman002@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| 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 |
Allopathic medicine |
Telmisartan (40 mg)
1 tablet of Telmisartan 40 mg orally for 21 days. |
| Intervention |
Polyherbal Unani Formulation |
Capsule form of extract of five Unani single drugs
1 capsule twice a day
orally for 21 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed patients of either sex with age limit from 18 years to 65 years with Essential Hypertension Grade 2 as per ACC criteria
Patient willing to participate and sign the informed understood consent form |
|
| ExclusionCriteria |
| Details |
Secondary hypertension
Patient with sign of end organ damage
Patient taking OCP and long term use of steroids
Pregnant & lactating women
Renal and hepatic insufficiency
other Cardiovascular disorder
malignancy
Patient who unwilling to sign the consent form |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To develop safe efficacious and cost effective drug for the management of Essential hypertension from herbal source |
baseline
7th day
14th day
21st day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Expected Blood pressure target to achieve around 120/80 mm Hg plus minus 10 mm Hg during mental & physical rest |
7 th day
14 th day
21 st day |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
25/05/2021 |
| 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="1"
Months="5"
Days="30" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Keeping view of higher prevalence of hypertension in India this trial is aimed for controlling blood pressure of such diagnosed Grade 2 essential hypertensive patient. It would be an randomized standard controlled study with a sample size of 60 patients.30 patients will be subjected to test drug ( Unani polyherbal formulation) and rest will be subjected to a allopathic medicine which is Telmisartan. Patient would be assessed weekly on the set parameters. Total duration of the protocol therapy would be 21 days |