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CTRI Number  CTRI/2025/07/090954 [Registered on: 15/07/2025] Trial Registered Prospectively
Last Modified On: 09/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Study on Quality of Life and Pharmacoeconomical burden on COVID recovered Diabetes with comorbidities patients  
Scientific Title of Study   Pharmaceutical Care impact on Health-Related Quality of Life (HRQoL) and Pharmacoeconomical Burden on COVID-Recovered Diabetic Patients with Comorbid Conditions 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sadanandam Akari 
Designation  Research Scholar 
Affiliation  Malla Reddy Institute of Pharmacy 
Address  402,Department of Pharmacy Practice, Malla Redddy Institute of Pharmaceutical Sciences, Maisammaguda
Kompally, Hyderabad,Telangana-500100
Hyderabad
TELANGANA
500100
India 
Phone  9989535600  
Fax    
Email  sadhapharmd@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Sadanandam Akari 
Designation  Research Scholar 
Affiliation  Malla Reddy Institute of Pharmacy 
Address  402,Department of Pharmacy Practice, Malla Redddy Institute of Pharmaceutical Sciences, Maisammaguda
Kompally, Hyderabad, Telangana-500100
Hyderabad
TELANGANA
500100
India 
Phone  9989535600  
Fax    
Email  sadhapharmd@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Sadanandam Akari 
Designation  Research Scholar 
Affiliation  Malla Reddy Institute of Pharmacy 
Address  402,Department of Pharmacy Practice, Malla Redddy Institute of Pharmaceutical Sciences, Maisammaguda
Kompally, Hyderabad, Telangana-500100
Hyderabad
TELANGANA
500100
India 
Phone  9989535600  
Fax    
Email  sadhapharmd@gmail.com  
 
Source of Monetary or Material Support  
Department of Pharmacy Practice, Malla Reddy Institute of Pharmaceutical Sciences, Maisammaguda, Hyderabad, Telangana, India Pin:500100 
 
Primary Sponsor  
Name  nil 
Address  nil 
Type of Sponsor  Other [] 
 
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 B Rajkamal  Malla Reddy Institute of Pharmacy  402,Department of Pharmacy Practice, Maisammaguda, Hyderabad, Telangana-500100
Hyderabad
TELANGANA 
9348161228

mrips_mrgi@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SWECCHA INDEPENDENT ETHICS COMMITTE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E00-E89||Endocrine, nutritional and metabolic diseases,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  1.Aged greater than 18 years
2.History of confirmed COVID-19 recovery
3.Diagnosed with Type 2 Diabetes Mellitus
4.At least one comorbid condition On pharmacologic treatment for diabetes and comorbidities
5.Able and willing to provide written informed consent
 
 
ExclusionCriteria 
Details  1.Type 1 Diabetes Mellitus or gestational diabetes
2.Patients with cognitive impairment or severe psychiatric illness
3.Patients receiving investigational drugs or enrolled in other clinical trials
4.Pregnant or lactating women
5.Patients unwilling to participate in follow-up
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Improving of Health related quality of life   1.Baseline (T0): At enrollment
2.3 months(T1):After Pharmaceutical care intervention period
3.6 Months(T2): Long term follow up 
 
Secondary Outcome  
Outcome  TimePoints 
Pharmaco economic burden (Direct medical cost, Indirect Medical cost)  1.Base line:(T0)
2.3 Months (T1)
3.6 months (T2) 
Drug Related problems  Continuous monitoring, summarized at 3 & 6 months 
 
Target Sample Size   Total Sample Size="500"
Sample Size from India="500" 
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)   21/07/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  21/07/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="3"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
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  

The worldwide commonness of diabetes is supposed to reach 10.5% (536.6 million individuals) by 2021, proposing a clinical emergency. Overseeing individuals with diabetes with comorbidities and those without COVID-19 overburdens the personal satisfaction and economy. To address this, medical care experts with clinical mastery have been attempting to foster a more extensive job in the therapy of diabetes. In spite of the fact that there is proof that drug treatment further develops glucose control, little is had some significant awareness of its impacts on human results, for example, wellbeing related personal satisfaction (HRQoL). The ebb and flow study incorporates a writing search in data sets, for example, IDF, CINAHL, Medline, Embase, Pubmed and worldwide articles by September 2021, alongside the extent of diabetes pharmacological treatment. For diabetics. Until this point in time, a couple of distributions have been distributed that show the pharmacological advantage of pharmacotherapy. There is no information to help guarantees that PCs have any sure monetary effect. This article surveys distributed examinations on the monetary investigation of medication organization to increment drug worth and supports the case that drug organization assists a PC with diminishing the monetary weight of patient downfall. locally by decreasing medication related dreariness and mortality.

 
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