| CTRI Number |
CTRI/2025/08/093930 [Registered on: 29/08/2025] Trial Registered Prospectively |
| Last Modified On: |
28/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
trial for assessing efficacy of treating anxiety in hypertensive patients. |
|
Scientific Title of Study
|
Randomized Controlled Trial of Pharmacotherapy for Anxiety in Hypertensive Patients on Multiple Antihypertensive Drugs |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Daksh Bansal |
| Designation |
Senior Resident |
| Affiliation |
AIIMS New Delhi |
| Address |
W9, 3rd floor, Green park main, New Delhi
Department of cardiology, All India institute of medical sciences, New Delhi, 110029
South
DELHI
110016
India |
| Phone |
9711178176 |
| Fax |
|
| Email |
daksh33bansal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rakesh Yadav |
| Designation |
Professor, Department of Cardiology |
| Affiliation |
AIIMS New Delhi |
| Address |
Department of cardiology, All India institute of medical sciences, Ansari Nagar, New Delhi 110029
Department of cardiology, All India institute of medical sciences, Ansari Nagar, New Delhi, 110029
South
DELHI
110029
India |
| Phone |
9868026888 |
| Fax |
|
| Email |
rakeshyadav123@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Daksh Bansal |
| Designation |
Senior Resident |
| Affiliation |
AIIMS New Delhi |
| Address |
W9, 3rd floor, Green park main, New Delhi
Department of cardiology, All India institute of medical sciences, New Delhi, 110029
South
DELHI
110016
India |
| Phone |
9711178176 |
| Fax |
|
| Email |
daksh33bansal@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Ansari Nagar, New Delhi 110029 |
|
|
Primary Sponsor
|
| Name |
All india institue of medical sciences, New Delhi |
| Address |
All india institute of medical sciences, New Delhi |
| 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 Daksh Bansal |
All india Institute of Medical sciences, ansari nagar, new delhi |
Department of Cardiology, Cardio Neuro Centre ( CNC building ), All india Institute of Medical sciences, ansari nagar, new delhi 110029
South
DELHI |
9711178176
daksh33bansal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| e ethics committee for post graduate research, all India institute of medical sciences, Ansari nagar New Delhi, 110029 |
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 |
pharmacotherapy |
pharmacotherapy for anxiety ( Tab escitalopram ) + pharmacotherapy for hypertension for a total duration of 12 weeks |
| Comparator Agent |
pharmacotherapy |
pharmacotherapy for hypertension ( no pharmacotherapy for anxiety ) for a duration of 12 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion criteria:
1. Hypertensive patients on at least 2 anti hypertensives.
2. Diagnosed with generalized anxiety disorder according to the DSM-5 criteria
3.Patient in the mild to moderate category of GAD (HAM A less than 25) |
|
| ExclusionCriteria |
| Details |
Exclusion criteria:
1. Patients with functional disability due ot anxiety.
2. Long QTc on Baseline ECG, or concomitant QTc prolonging drugs.
3. Patients with a primary psychiatric diagnosis other than anxiety disorder will be excluded, including
patients with MDD (major depressive diorder), PTSD (post traumatic stress disorder), OCD (obsessive compulsive disorder), or any of the following DSM-5 diagnoses: 1) Dementia, delirium; 2) Schizophrenia, Schizoaffective, or other psychotic disorder; 3) Psychotic features including any delusions or hallucinations.
4. Patients with secondary causes of hypertension.
5. Current alcohol or other substance abuse disorder.
6. Patient taking herbal supplements.
7. Pregnant and lactating females will be excluded. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in anxiety symptoms as assessed by Hamilton Anxiety Rating scale (HAM-A). |
4 weeks, 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in blood pressure control |
4 weeks, 12 weeks |
| adverse events |
4 weeks, 12 weeks |
| change in quality of life assessed by WHOQOL-BREF questionnaire |
4 weeks, 12 weeks |
|
|
Target Sample Size
|
Total Sample Size="105"
Sample Size from India="105"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
15/09/2025 |
| 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
|
Our research project titled Randomized Controlled Trial of Pharmacotherapy for Anxiety in Hypertensive Patients on Multiple Antihypertensive Drugs has been designed with a background that anxiety is an under treated and under diagnosed problem in patients of hypertension who are taking multiple antihypertensive drugs. The aim of our study is to assess the efficacy of anxiety pharmacotherapy in such a population in managing anxiety symptoms and its effect on blood pressure control and quality of life. We hope to provide evidence for management of anxiety in patients with hypertension on multiple anti-hypertensive drugs. Future directions: long term follow up will be needed of these patients to evaluate for sustained effect and explore for possible treatment alternatives. |