| 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
|
|
|
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
|
|
|
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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