| CTRI Number |
CTRI/2024/10/074626 [Registered on: 03/10/2024] Trial Registered Prospectively |
| Last Modified On: |
21/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To see the efficacy of qurs musakkkin on increase blood pressure and comparision with telmisartan |
|
Scientific Title of Study
|
A Clinical study on Zightudam Qawi Ibtidai ( Grade I Essential Hypertension ) and Comparative Evaluation of Qurs-e- Musakkin with Standard Control Drug Telmisartan in its Managament |
| Trial Acronym |
ACSZQICEQM |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
NAVED AHMAD |
| Designation |
M.D Scholar department of moalajat |
| Affiliation |
Ajmal Khan Tibbiya College |
| Address |
Department of Moalajat Ajmal Khan Tibbiya College Aligarh Muslim University Aligarh
Department of Moalajat Ajmal Khan Tibbiya College Aligarh Muslim University Aligarh
Aligarh
UTTAR PRADESH
202001
India |
| Phone |
9997479228 |
| Fax |
|
| Email |
naved.amu2016@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mursaleen Naseer |
| Designation |
Assistant professor department of moalajat |
| Affiliation |
Ajmal Khan Tibbiya College |
| Address |
Department of Moalajat Ajmal Khan Tibbiya College Aligarh Muslim University Aligarh
Department of Moalajat Ajmal Khan Tibbiya College Aligarh Muslim University Aligarh
Aligarh
UTTAR PRADESH
202001
India |
| Phone |
9412562724 |
| Fax |
|
| Email |
drmursaleennaseer@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
NAVED AHMAD |
| Designation |
M.D Scholar department of moalajat |
| Affiliation |
Ajmal Khan Tibbiya College |
| Address |
Department of Moalajat Ajmal Khan Tibbiya College Aligarh Muslim University Aligarh
Department of Moalajat Ajmal Khan Tibbiya College Aligarh Muslim University Aligarh
Aligarh
UTTAR PRADESH
202001
India |
| Phone |
9997479228 |
| Fax |
|
| Email |
naved.amu2016@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dawakhana Tibbiya Collage Aligarh Muslim University Aligarh
|
|
|
Primary Sponsor
|
| Name |
Department of Moalajat Ajmal Khan Tibbiya Collage Aligarh Muslim University Aligarh |
| Address |
Department of Moalajat Ajmal Khan Tibbiya Collage Aligarh Muslim University Aligarh |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Dr Naved |
Ajmal khan tibbiya college hospital |
Department of moalejat faculty of unani medicine amu Aligarh
Aligarh
UTTAR PRADESH |
9997479228
drnavedmd22@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 |
| Intervention |
qurs musakkin |
2 tab once a day for 60 days orally |
| Comparator Agent |
Telmisartan
|
1 tab once a day orally for 60 days |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
clinically diagnosed patients of grade 1 essential hypertension (according to WHO/ISH,SBP-139-159 mmhg and DBP 90-99 mmhg on three consecutive visits unfer optimal condition with or without subjective parameters.
patients of either sex
patients in the age group of 35years to 60 years .
no evidence of target organ damage.
patients not taking any anti hypertensive drugs prior to state of treatment
those who give written consent. |
|
| ExclusionCriteria |
| Details |
patients of severe and secondary hypertension.
patients of below 35years and above 60 years.
pregnant women and lactating mothers.
patients with comorbid conditions like liver,kidney,or heart diseases.
patients with clinical or laboratory evidence of target organ damage.
patients of altered mental status.
patients who do not sign informed concent form. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
improvement in following criteria
systolic bp
dystolic bp |
two months with fortnightly follow uo |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
improvement in following criteria
headache
giddiness
palpitation
fatigue |
two months with fortnightly follow uo |
|
|
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)
|
06/10/2024 |
| 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="6"
Days="0" |
|
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
|
Hypertension is the condition in which arterial blood pressure is chronically elevated .the risk of cardiovascular disease such as stroke and CAD is closely related to levels of blood pressure ,to overcome the problem of HTN several classes of antihypertensive drugs have been introduced in modern system of medicine but apart from being effective ,most of these medicines are costly have adverse effects and also they fail to prevent complications of HTN and also cause economic burden on the patients .in ancient unani literature there is description of many drugs ( single and compounds )that have been used for the management of HTN so there is a need to provide efficacious drugs with less side effects for the management of HTN ,keeping in view of above factors it is intented to adopt a study entitled. |