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CTRI Number  CTRI/2025/04/085179 [Registered on: 21/04/2025] Trial Registered Prospectively
Last Modified On: 25/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   prevalence of stress in hypertention 
Scientific Title of Study   prevalence of stress among Daght al-Dam Qawi pts attending NIUM Hospital, A cross sectional study  
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  MOMIN ARSHAD MANZOOR AHMED 
Designation  PG Scholar 
Affiliation  National Institute Of Unani Medicine  
Address  Department of tahffuzi wa samaji tib, National Institute of Unani Medicine, Magadi main road ,Kottigeplaya, Bengaluru, Karnataka, India
Departmet of tahffuzi wa samaji tib,national innstitute of unani medicine ,kottigepalya,bengaluru
Bangalore
KARNATAKA
560091
India 
Phone  09762612689  
Fax    
Email  mominarshad2015@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  PROF ABDUL HASEEB ANSARI 
Designation  Professor 
Affiliation  National Institute of Unani Medicine  
Address  Department of Tahaffuzi wa Samaji Tib, National Institute of Unani Medicine, Magadi Main Road, Kottigepalya, Bengaluru,
Department of Tahaffuzi wa Samaji Tib, National Institute of Unani Medicine, Magadi Main Road, Kottigepalya,
Bangalore
KARNATAKA
560091
India 
Phone  9448258140  
Fax    
Email  ahansari001@gmail.com  
 
Details of Contact Person
Public Query
 
Name  MOMIN ARSHAD MANZOOR AHMED 
Designation  PG Scholar  
Affiliation  National Institute of Unani Medicine, Magadi main road ,Kottigeplaya, Bengaluru, Karnataka, India  
Address  Department of tahffuzi wa samaji tib, National Institute of Unani Medicine, Magadi main road ,Kottigeplaya, Bengaluru, Karnataka, India
Department of tahffuzi wa samaji tib , National Institute of Unani Medicine, Magadi main road ,Kottigeplaya, Bengaluru, Karnataka, India
Bangalore
KARNATAKA
560091
India 
Phone  09762612689  
Fax    
Email  mominarshad2015@gmail.com  
 
Source of Monetary or Material Support  
Department of tahaffuzi wa samaji Tib ,National Institute Of Unani Medicine,Magadi main road , kottigepalya 560091, bengaluru,, karnataka, india  
 
Primary Sponsor  
Name  MOMIN ARSHAD MANZOOR AHMED 
Address  National Institute of Unani Medicine, magadi main road, kottigepalya, 560091 bengaluru,karnatka,india 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Arshad  National institute of unani medicine   Department of tahffuzi wa samaji tib, National Institute of Unani Medicine, Magadi main road ,Kottigeplaya, Bengaluru, Karnataka, India
Bangalore
KARNATAKA 
09762612689

mominarshad2015@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Communication of Decicsion of the Institutional Ethics Committee (IEC) For Biomedical Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G||Mental Health,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nill  Nill 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  .All dignosed cases of hypertenion both primary and secondary,patinets of all gender and age betwen 18 to 70 years would be included in the study 
 
ExclusionCriteria 
Details  patinet who do not give consent and do not co operate will be excluded from study  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Stress in hypertensive patients  Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
Blood pressure variability
Medication adherence  
1 year  
 
Target Sample Size   Total Sample Size="219"
Sample Size from India="219" 
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)   02/05/2025 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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
Modification(s)  
Hypertension is one of the leading causes of the global burden of disease. Hypertension doubles the risk of cardiovascular disease, including coronary heart disease, congestive heart failure, ischemic and hemorrhagic stroke, renal failure, and peripheral arterial disease. Hypertension is the most common public health problem in both developed and developing countries. Hypertension (HTN) is the sustained elevation of arterial blood pressure; normal values of systolic and diastolic blood pressure at rest are <120 and <80 mmHg, respectively. Hence, hypertension is said to be present when blood pressure is found to be persistently elevated at or above 140/90 mmHg.2
Primary hypertension is said to be essential when the cause is unknown.
Secondary hypertension is usually caused by a treatable underlying pathology. (i) Endocrine causes: Cushing’s syndrome, primary aldosteronism, primary hyperparathyroidism, hypothyroidism, and acromegaly pheochromocytoma. (ii) Renal causes: primary sodium retention, renal parenchymal disease, renin-producing tumor (iii) Drugs: NSAIDs, immunosuppressants, etc. Associated risk factors of hypertension are classified as modifiable and non-modifiable risk factors. The modifiable risk factors are overweight or obesity, sedentary lifestyle, tobacco usage, unhealthy diet, excessive alcohol usage, stress, sleep apnea, uncontrolled diabetes mellitus, and non-modifiable risk factors are age, sex, race, family history, genetic factors, etc.
High blood pressure affects over a billion individuals globally and is considered to be the cause 9.4 million deaths each year. Using a range of methods, several small regional surveys carried out in India over the past 20 years have reported prevalences ranging from 3% to 36% in males 15.80% to 37.2% in women in rural areas to 6.15%-36.3% in men and 21%-39,4% in women in urban areas. Around the age of fifty, men are more likely than women to develop hypertension of the state’s and In Karnataka, hypertension affects 12.6% 
The risk of congestive heart failure is increased four times, the risk of coronary artery disease is doubled, and the risk of cerebrovascular disease is seven times higher in those with hypertension. In developing nations, it ranks fourth, and in developed nations, it ranks seventh, in regard to early death. As a result, hypertension is seen as a significant public health issue in the twenty- first century.
Psychological distress, including anxiety and depression, is a risk factor for hypertension. Studies show a bidirectional relationship: stress increases hypertension risk, and hypertensive patients experience more psychosocial stress than normotensive individuals." According to recent studies, the pathophysiology of hypertension could possibly require the blood pressure’s return to its pre-stress resting state. Inadequate blood pressure recovery after mental stress is a predictor of future blood pressure values, sometimes more so than responsiveness, according to prospective studies."
According to all the previous studies and research, it is concluded that stress is also a complication of HTN, if it is not treated properly within time, it may get more complicated and lead to other diseases, hence its prevention and treatment is necessary. Therefore, it is the need of hour that everybody should know about such type of factors. For this purpose, the awareness study is a must, so I am planning to do this study, aims to screening of the patients of hypertension for levels of stress and also create awareness among them about its adverse effect. This study may also be helpful to provide proper guidance and effective education to the patients as well as their relatives. On the basis of this study researcher may also be able to suggest forming prevention plans, and advise proper exercise, lifestyle change strategies and therapeutic impact on patients and they also may be able to formulate better management plans for the care, and its consequence such as stress, so that hypertension patient can also bloom like a flower again as he/she used to be before getting such illness.

 
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