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CTRI Number  CTRI/2025/09/094586 [Registered on: 11/09/2025] Trial Registered Prospectively
Last Modified On: 10/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Adding Zinc to Blood Pressure Medications: Effects on Blood Pressure and Well-Being 
Scientific Title of Study   Efficacy and Safety of Zinc Supplementation on Blood pressure and Quality of life in patients receiving Telmisartan and Hydrochlorothiazide combination: A randomised open label 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  Mini Sharma 
Designation  Academic Junior Resident  
Affiliation   
Address  Department Of Pharmacology, AIIMS HOSPITAL, RAJKOT

Rajkot
GUJARAT
360006
India 
Phone  9997031404  
Fax    
Email  mini231998@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Shubha Singhal 
Designation  Assistant Professor 
Affiliation   
Address  Department Of Pharmacology, AIIMS Rajkot

Rajkot
GUJARAT
360006
India 
Phone    
Fax    
Email  drshubhasinghal@gmail.com  
 
Details of Contact Person
Public Query  
Name  Mini Sharma 
Designation  Academic Junior Resident  
Affiliation   
Address  Department Of Pharmacology, AIIMS Rajkot

Rajkot
GUJARAT
360006
India 
Phone  9997031404  
Fax    
Email  mini231998@gmail.com  
 
Source of Monetary or Material Support  
AIIMS, Khanderi, Para Pipaliya, Rajkot, Gujarat, India, 360006 
 
Primary Sponsor  
Name  Mini Sharma 
Address  Department Of Pharmacology, AIIMS Rajkot, khanderi, Para Pipaliya, Gujarat, India, 360006 
Type of Sponsor  Government medical college 
 
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 Mini Sharma  AIIMS Rajkot  Department of Pharmacology and Department of General Medicine
Rajkot
GUJARAT 		 9997031404

mini231998@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC AIIMS Rajkot  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I10||Essential (primary) hypertension,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Telmisartan plus hydrochlorothiazide  Telmisartan 40 mg and Hydrochlorothiazide 12.5 mg once daily in the morning at for three month  
Intervention  Telmisartan plus hydrochlorothiazide with zinc sulphate  Telmisartan 40 mg and Hydrochlorothiazide 12.5 mg once daily in the morning at for three month + Zinc 20 mg elemental zinc once daily for three months.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients aged between 18 to 65 years

Newly diagnosed case of Grade 1 primary hypertension Systolic BP 140 to 159 mm of Hg DBP 90 to 99 mm Hg

Patient is willing to come for follow up till 12 weeks

Patient is willing to give informed written consent 
 
ExclusionCriteria 
Details  Patient suffering with Stage 2 or stage 3 primary hypertension

Patient suffering with diagnosed secondary hypertension

Patients have contraindication or allergic to Zinc, Telmisartan or Hydrochlorothiazide
Patient giving history of taking mineral supplement in last 3 month before enrolment

Patient having history of ischemic heart disease, stroke, congestive heart failure, clinically significant arrhythmia or conduction disorders, diagnosed end stage renal disease, abnormal liver function or critically ill patient
Systolic Blood pressure difference in both arms more than 10 mmHg

Pregnant female

Lactating mother 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. Change in systolic blood pressure (SBP) from baseline to 12 weeks.
2. Change in diastolic blood pressure (DBP) from baseline to 12 weeks. 		 All the patients will be asked to come for follow-up at 4, and 8- and 12-weeks post-treatment and
patients will be evaluated thoroughly for the efficacy, and safety parameters at each visit. 
 
Secondary Outcome  
Outcome  TimePoints 
1) Change in quality of life from baseline to 12 weeks.
2) Incidence, type, causality, preventability and severity of adverse effects in both
the group. 		 1)Quality of life will be evaluated at baseline and 12th week.
2)Any adverse effect will be evaluated and reported during study duration from baseline till 12 weeks. 
 
Target Sample Size   Total Sample Size="142"
Sample Size from India="142" 
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 4 
Date of First Enrollment (India)   01/10/2025 
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="2"
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   Studies have shown that zinc plays a multifaceted role in regulating blood pressure through vascular, renal, and inflammatory pathways. Also it is proven that standard antihypertensive regimens can  cause depletion of zinc, therefotre it’s plausible that adding zinc supplementation could improve outcomes. Thus, comparing combination therapy of telmisartan and hydrochlorthiazide with zinc versus without zinc to evaluate if there is better  blood pressure control and overall well-being.


 
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