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CTRI Number  CTRI/2025/07/091439 [Registered on: 22/07/2025] Trial Registered Prospectively
Last Modified On: 22/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Screening
Behavioral 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A Study to See How Pharmacist Support Helps Improve Health and Well-being in People with Rheumatoid Arthritis 
Scientific Title of Study   Impact of Pharmacist Intervention on Therapeutic Outcome and Quality of Life of Patients Suffering Fom Rheumatoid Arthritis: A Randomized 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  TRIVENI JAGADISH UMARANI 
Designation  Research Scholar 
Affiliation  KLE Academy of Higher Education and Research Deemed to be University 
Address  Department of Pharmacy Practice,KLE college of Pharmacy, Vidyanagar, Hubballi
KLE College of Pharmacy, Hubballi
Dharwad
KARNATAKA
580031
India 
Phone  6361926994  
Fax    
Email  triveniumarani@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. AHM Viswanatha Swamy 
Designation  Principal and Professor  
Affiliation  KLE Academy of Higher Education and Research Deemed to be University 
Address  Principal of KLE College of Pharmacy, Vidyanagar, Hubballi
KLE College of Pharmacy, Hubballi
Dharwad
KARNATAKA
580031
India 
Phone  9448667355  
Fax    
Email  vmhiremath2004@gmail.com  
 
Details of Contact Person
Public Query  
Name  TRIVENI JAGADISH UMARANI 
Designation  Research Scholar 
Affiliation  KLE Academy of Higher Education and Research Deemed to be University 
Address  Department of Pharmacy Practice, KLE College of Pharmacy, Vidyanagar, Hubballi.
KLE College of Pharmacy, Hubballi
Dharwad
KARNATAKA
580031
India 
Phone  6361926994  
Fax    
Email  triveniumarani@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  KAHER KLE COLLEGE OF PHARMACY 
Address  KLE College, Pharmacy, Vidyanagar, Hubballi 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
Arthritis Superspeciality Center Hubballi  Arthritis, Superspeciality Center, Vikas Nagar, Hosur Cross, Hubballi 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Vikram Haridas  ARTHRITIS SUPERSPECIALITY CENTER  Arthritis Superspeciality Center, Vikas Nagar, Hosur Cross, Hubballi
Dharwad
KARNATAKA 		 9343649883

vikramharidas@gmail.com 
 
Details of Ethics Committee  
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M258||Other specified joint disorders,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Comparator  Standard treatment plan 
Intervention  Intervention  Standard treatment plan + pharmaceutical care (Counselling, Education about adherence to the medications, maintain the body weight, regular follow up). 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Adults above 18years
Patients receiving atleast one DMARD therapy
Patients willing to participate and provide informed consent form  
 
ExclusionCriteria 
Details  Patients with other autoimmune or inflammatory disorders.
Patients who are unable or unwilling to provide informed consent.
Pregnant or lactating women.
Psychiatric patients.
 
 
Method of Generating Random Sequence    
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. To evaluate the impact of pharmacist intervention on disease activity using the DAS-28 (Disease Activity Score-28) and to assess the improvement in quality of life using SF 36 Scale in patients with RA.
2. To perform a Cost-Effectiveness Analysis (CEA) of the pharmacist intervention versus standard care in the management of RA.
 		 8 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
1.To assess the Knowledge, Attitude, & Practice (KAP) of patients regarding their disease, treatment regimen, & lifestyle before & after pharmacist intervention.
2.To conduct Drug Utilization Evaluation (DUE) of medications prescribed to RA patients, analyzing patterns, rationality, & adherence.
 		 8 weeks 
 
Target Sample Size   Total Sample Size="386"
Sample Size from India="386" 
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)   05/08/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  05/08/2025 
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [triveniumarani@gmail.com].

  6. For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

1.     Demographic and Clinical Data: Information on age, gender, social history, and concurrent medications will be collected from patient medical records.

2.     Knowledge, Attitude, and Practice (KAP) Survey: A structured questionnaire will be used to assess participants’ knowledge, attitude, and practices related to RA and its management. The questionnaire will be administered at baseline and after the study period to measure any changes.

3.     Efficacy Assessment: Clinical efficacy of DMARDs will be evaluated using the Disease Activity Score 28 (DAS-28) scale. The DAS-28 score will be recorded during the study period.

4.     Quality of Life (QoL) Assessment: Quality of life will be assessed using the validated Health Assessment Questionnaire (HAQ) specific to RA, which will be administered at baseline and follow-up intervals to capture changes over time.

5.     Drug Utilization Evaluation (DUE): Data on drug utilization patterns will be analyzed based on the WHO/INRUD prescribing indicators, including the average number of drugs per encounter, percentage of encounters with an antibiotic, and percentage of encounters with an injection.

6.     Cost Analysis: Direct medical costs will be calculated, including the costs of DMARDs, hospitalizations, laboratory investigations, and other related medical expenses. Indirect costs, such as loss of productivity, will also be recorded and assessed through patient self-reports.

7.     Results will be analyzed using suitable statistical test.

 
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