| 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
|
|
|
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
|
|
|
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. |