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CTRI Number  CTRI/2025/09/094755 [Registered on: 15/09/2025] Trial Registered Prospectively
Last Modified On: 12/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Educational Package]  
Study Design  Cluster Randomized Trial 
Public Title of Study   Effectiveness of educational package on knowledge and practice regarding self- medication among adults at Agartala, Tripura. 
Scientific Title of Study   A study of effectiveness of educational package on knowledge and practice regarding self- medication among adults. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mrs Dipanti Das  
Designation  Ph.D. Scholar 
Affiliation  Teerthanker Mahaveer University 
Address  Teerthanker Mahaveer University Delhi Road NH 9 Moradabad Uttar Pradesh

Moradabad
UTTAR PRADESH
244001
India 
Phone  9774035448  
Fax    
Email  dipanti.scholar@tmu.ac.in  
 
Details of Contact Person
Scientific Query
 
Name  Prof Dr MJasline 
Designation  Principal 
Affiliation  Teerthanker Mahaveer University 
Address  Teerthanker Mahaveer University Delhi Road NH 9 Moradabad Uttar Pradesh

Moradabad
UTTAR PRADESH
244001
India 
Phone  8279816167  
Fax    
Email  drjaslinejohn.msn@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Prof Dr MJasline 
Designation  Principal 
Affiliation  Teerthanker Mahaveer University 
Address  Teerthanker Mahaveer University Delhi Road NH 9 Moradabad Uttar Pradesh

Moradabad
UTTAR PRADESH
244001
India 
Phone  8279816167  
Fax    
Email  drjaslinejohn.msn@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Mrs Dipanti Das 
Address  Teerthaker Mahaveer University Delhi Road NH 9 Moradabad 244001 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr MJasline  Municipal Council  Agartala, Tripura, West Pin- 799003
West Tripura
TRIPURA 
08279816167

drjaslinejohn.msn@gmail.com 
Mr Amit Kumar Dhar  Municipal Council   Agartala Tripura West Pin- 799001
West Tripura
TRIPURA 
09774482172

onlineamit13@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Teerthanker Mahaveer Dental College & Research Centre  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Self- Medication Practices 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Educational Package on Self-medication  Health Education using Various teaching aids such as posters, leaflets, charts, PPTs etc for a period of 45 mins. 
Comparator Agent  No Intervention  There will be no intervention for the Control group 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Individuals between the ages of 18 and 60 who self-medicate.
Who can read and/or write Bengali and/or English.
Accessible when the data was being collected.
 
 
ExclusionCriteria 
Details  8Who are seriously ill, or have any mental or physical disability.
Who work as paramedics, nurses, pharmacists, and registered medical practitioners.8888888Those unwilling to participate in the research project.
 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Increase in knowledge and practice of self-medication among Adults
 
Knowledge will be assessed after 1 week and Practice will be assessed after 3 weeks interval 
 
Secondary Outcome  
Outcome  TimePoints 
NIL   
 
Target Sample Size   Total Sample Size="588400"
Sample Size from India="588400" 
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)   01/01/2026 
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="1"
Days="15" 
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  

BRIEF DESCRIPTION OF THE STUDY PROPOSAL

1.       INTRODUCTION:

 

          The main public health resource available inside the healthcare system is self-care. It covers health-related behaviours and decisions made by people, families, friends, coworkers, and so forth. It includes first aid in daily life, self-medication, self-treatment without the use of drugs, and social support during illness1. Self-medication refers to the act of obtaining and ingesting medications without consulting a doctor. The World Health Organization explains “Self-medication involves the use of medicinal products by the consumer to treat self-recognized disorders or symptoms, or the intermittent or continued use of a medication prescribed by a physician for chronic or recurring diseases or symptoms. In practice, it also includes use of the medication of family members, especially where the treatment of children or the elderly is involved”.

 

Self-medication is increasingly acknowledged to have a significant role in the healthcare system these days. This change in perspective has been facilitated by the realization that people are ultimately responsible for their own health and that seeking professional care for mild illnesses is frequently not essential. The fact that self-medication is selected voluntarily by people for situations in which it seems favourable to them is highlighted by the social and economic advantages of this practice. It is typically chosen for use in cases of symptoms and ailments that the patient deems to be bothersome enough to require medical attention but not severe enough to warrant seeing a doctor. One will seek expert medical assistance only if the problem is inoperable, continues, or worsens1.

India, with its vast and diverse population, exhibits a high prevalence of self-medication, especially among adults. The situation is compounded by cultural beliefs, financial constraints, and inadequate healthcare infrastructure. Studies have reported common use of analgesics, antibiotics, antipyretics, and gastrointestinal drugs without medical consultation, often leading to adverse drug reactions, antimicrobial resistance, and delayed diagnosis of serious conditions.

In rural and semi-urban areas, where formal medical services may be scarce or underutilized, self-medication becomes an easily accessible alternative. Even in urban settings, time constraints and perceived convenience push individuals to bypass professional consultation. Despite these widespread practices, there is limited awareness regarding the risks associated with improper self-medication.

Educational interventions are widely recognized as effective strategies to address health knowledge gaps and promote safe health behaviours. An educational package that provides accurate, easy-to-understand, and culturally appropriate information on the rational use of medicines can be a powerful tool to empower individuals and promote safer practices. It is imperative to assess whether such packages can positively influence knowledge and change harmful self-medication behaviours.

2.      NEED FOR THE STUDY:

The World Health Organization (WHO) recognizes responsible self-medication as part of primary healthcare, provided it is carried out with accurate information. However, in India, several studies have highlighted poor awareness among the public regarding the dosage, side effects, and drug interactions of self-medicated drugs. This underscores the urgent need to enhance public knowledge and practices.

Adults, being the primary decision-makers in families, often influence healthcare decisions not only for themselves but also for children and the elderly. Therefore, targeting this group with an effective educational strategy has the potential to reduce harmful self-medication practices and create a ripple effect across entire households and communities.

 

Limited research exists on structured educational interventions addressing self-medication in the Indian context, particularly in underrepresented regions such as North-East India. By evaluating the effectiveness of an educational package, this study seeks to contribute to evidence-based public health strategies aimed at promoting rational drug use.

Lalthanmawii P, Rokhuma L (2017) conducted a Cross-sectional survey to assess the Self-Medication Practices in College Students in Mizoram. 180 undergraduate students participated in the study. Data were collected using structured questionnaires. The study findings showed that 81% of students reported self-medication, commonly for headaches, colds, and menstrual cramps. Peer advice and internet were common sources of information. Only 15% were aware of possible drug interactions. The study highlights the influence of digital media and peer learning in youth behaviors, and the need for digital health literacy programs.

Taba S, Tayeng T, Lego M (2021) conducted a Mixed-method (quantitative survey + qualitative interviews) study on the Knowledge and Attitude Towards Self-Medication Among Tribal Adults in Arunachal Pradesh. Among the 200 tribal adults, around 63% practiced self-medication, mostly with herbal remedies and OTC drugs. Literacy rate was low (48%), and there was minimal awareness of drug side effects. Cultural beliefs strongly influenced self-treatment choices. The study stressed on region-specific educational approaches that integrate traditional beliefs with biomedical education.

In North East India, not much research has been done at the community level to determine the extent of self-medication practices. Research of this kind will shed light on the motivations behind patients’ use of this technique and may assist regulatory bodies and legislators in developing drug regulations, updating the list of necessary medications, and addressing safety issues with over-the-counter medications. In order to ascertain the prevalence of self-medication, related determinants, and its effects on health among people in Agartala, Tripura, this study has been designed.

3. LITERATURE REVIEW

1. Prevalence of Self-Medication

Several cross-sectional studies across India and abroad report high prevalence of self-medication (SM) among adults and students.

  • Kamini et al. (2022) found a 65.3% prevalence in an urban area, with headaches and colds being common reasons. Pharmacists and the Internet were major information sources.
  • Gupta & Chakraborty in Kolkata reported 57.7% prevalence, with painkillers being most used and higher education linked to lower SM.
  • Shalini & Logaraj (2021) in Tamil Nadu reported 32.5% prevalence; males were 1.5 times more likely to self-medicate.
  • Kumar et al. in Delhi found an alarming 92.8% prevalence, especially among younger and educated populations.
  • Patil et al. (2019) in rural Pune reported 74% prevalence; awareness of risks was low.
  • Behzadifar et al. (2020) conducted a meta-analysis among students globally and found 70.1% prevalence, with higher rates among medical students.
  • Vincent & James (2019) reported over 80% SM among medical and paramedical students in Kerala.

 

 

2. Knowledge and Practice Related to Self-Medication

Studies reveal moderate knowledge but poor practice related to SM, especially in terms of antibiotic misuse and source reliability.

  • Rahimisadegh et al. (2021) found 44.8% of Iranian students practiced SM; social media was a major source of information.
  • Sharma et al. (2019) in AIIMS Rishikesh showed 78.7% antibiotic SM among nursing students, with frequent discontinuation and medication switching.
  • Gupta et al. (2019) in Jammu found 78% prevalence among medical students; knowledge was moderate, and Internet/past prescriptions were key information sources.
  • Garg et al. (2018) in rural Punjab reported ~75% SM among youth, with convenience and cost savings as major motivators.
  • Delhi University (2012) found 85.4% SM prevalence among students; despite awareness of risks, behavior did not change significantly.
  • North Karnataka study (2020) found higher SM in urban than rural populations, correlated with education and socioeconomic status.
  • Jordanian study (2022) highlighted that medical professionals and those relying on non-scientific sources were more prone to SM.

3. Effectiveness of Educational Interventions on Self-Medication

Quasi-experimental and pre-experimental studies demonstrate that educational interventions significantly improve knowledge and safe practices.

  • Rani & Sharma (2021) in Haryana showed knowledge scores improved from 6.4 to 13.8 post-intervention; practices also improved.
  • Nair & Joseph (2020) in Kerala found knowledge increased from 5.6 to 12.4, with a 40% rise in safe practices post-intervention.
  • Verma & Mishra (2020) in Lucknow reported improved knowledge (8.4 to 14.9) and 32% rise in safe behaviors.
  • Joshi & Ramesh (2019) in Bengaluru used audiovisual tools; knowledge rose from 6.3 to 13.5, and confidence in seeking medical advice improved.
  • Patel & Shah (2021) in Ahmedabad confirmed that educational interventions significantly reduced irrational SM, especially in rural settings.

 

4.PROBLEM STATEMENT:

A study of effectiveness of educational package on knowledge and practice regarding self- medication among adults.

5. OBJECTIVES:

·         To assess the prevalence of Self-medication among adults.

·         To assess the Pre- test level of knowledge and practice regarding self- medication among adults.

·         To find out the correlation between the pre- test level of knowledge and practice regarding self-medication among adults.

·         To find out the effectiveness of Educational Package on knowledge and practice regarding Self- medication among adults.

·         To find out the association between knowledge regarding self-medication among adults with their selected socio-demographic variables.

·         To find out the association between practice regarding self-medication among adults with their selected socio-demographic variables.

6.RESEARCH METHODOLOGY:

·         Research approach: Quantitative research approach.

·         Research design: Quasi- experimental design.

·         Research setting: The study will be conducted at Agartala Municipal Council Area, Agartala, Tripura (West).

·         Target Population:  Adults residing at Agartala Municipal Council Area, Agartala, Tripura (West).

·         Sampling technique: Cluster Random sampling technique will be employed to select samples.

·         Criteria for Sample Selection

 

     Inclusion Criteria: - The study will include adults

Ø  Individuals between the ages of 18 and 60 who self-medicate.

Ø  Who can read and/or write Bengali and/or English.

Ø  Accessible when the data was being collected.

     Exclusion Criteria:- The study will exclude adults

Ø  Who are seriously ill, or have any mental or physical disability.

Ø  Who work as paramedics, nurses, pharmacists, and registered medical practitioners.

Ø  Those unwilling to participate in the research project.

7.OUTCOME MEASURES OR RESEARCH TOOLS/INSTRUMENTS

Section A: sociodemographic information of the participants

Section B: Structured knowledge questionnaire to assess the knowledge regarding Self- medication.

Section C: Practice Checklist to assess self-medication practices.

8. PLAN FOR DATA COLLECTION

Phase 1: Pre-test will be conducted to assess the existing knowledge and practice of Self-medication in both experimental and control groups.

Phase 2: Educational Package will be implemented in the experimental group.

Phase 3: Post- test will be conducted in both experimental and control groups (after 7 days to assess the knowledge and 21 days for evaluating the practice).

9.PLAN FOR DATA ANALYSIS

Data will be analyzed in the following steps:

Data Preparation Coding, cleaning, and entry.

Descriptive Statistics Frequency, percentage, mean, median and SD

Effectiveness Testing –McNemar’s Test, Independent t-test, ANOVA

Correlation Analysis Pearson or Spearman correlation to assess the relationship between participant’s knowledge and practice.

Demographic Associations Independent t-test, ANOVA, or Chi-square test as appropriate for data type and distribution.

10. FUTURE CONTRIBUTIONS OF THE STUDY:

This study is expected to make significant contributions to public health knowledge, policy, and community-based educational strategies in the following ways:

1. Contribution to Health Education

The findings from this study will help develop evidence-based educational materials and strategies tailored to adult populations, especially in the Indian context. If the educational package is found effective, it can serve as a model tool to be adopted and scaled up by healthcare educators, community health workers, NGOs, and public health institutions.

2. Policy Implications

By highlighting gaps in knowledge and unsafe practices regarding self-medication, this study can inform healthcare policymakers about the urgent need for structured community awareness programs. It may also prompt authorities to regulate over-the-counter drug sales more stringently and promote rational drug use through national health campaigns.

3. Empowering Communities

Educating adults—who are often the primary caregivers in families—has the potential for long-term behavioral changes at the household level. The knowledge gained by participants may extend to influence the self-medication behavior of their family members, creating a multiplier effect and fostering a culture of safe medication practices.

4. Academic and Research Contribution

This study will add to the limited body of Indian research on the effectiveness of educational interventions in reducing unsafe self-medication practices. It may serve as a reference for future researchers interested in exploring similar interventions in diverse settings and populations.

5. Region-Specific Relevance

If conducted in under-researched or underserved regions such as North-East India, the study will help fill regional data gaps and bring attention to the unique challenges faced in those areas. This will help tailor future interventions that are culturally and regionally sensitive.

6. Strengthening Preventive Healthcare

The study aligns with India’s broader public health goals of preventive and promotive healthcare. By focusing on education as a tool for behavior change, it supports the National Health Policy’s objective of improving health literacy and reducing the burden of preventable drug misuse.

11.REFERENCES:

1. Guidelines for the regulatory assessment of medicinal products for use in self-medication. Geneva,  World Health Organization, 2000. (2000). Accessed: November 29,2022:  https://apps.who.int/iris/bitstream/handle/10665/66154/WHO_EDM_QSM_00.1_eng.pdf.

2. Lalthanmawii P, Rokhuma L. A study on self-medication practices among college students in Aizawl, Mizoram. Indian J Pharm Pract. 2017;10(2):108-112.

3. Taba S, Tayeng T, Lego M. Knowledge and attitude toward self-medication among tribal adults of Arunachal Pradesh: A mixed-method study. Indian J Health Sci Res. 2021;11(3):56-61.

4.Kamini, B., Vidhyashree, M. D., Sundarrajan, I. B., Jayakumar, A. U., & Nandini, M. S. (2022). A study on prevalence and determinants of self-medication practice among urban population in a tertiary care setting. Journal of Family Medicine and Primary Care.

5.Gupta, S., & Chakraborty, A. (n.d.). A cross-sectional descriptive study on self-medication practices in an urban field practice area of a medical college in Kolkata. International Journal of Community Medicine and Public Health.

6.Behzadifar, M., Behzadifar, M., Aryankhesal, A., Ravaghi, H., Baradaran, H. R., Sajadi, H. S., et al. (2020). Prevalence of self-medication among students: A systematic review and meta-analysis. Eastern Mediterranean Health Journal, 26(8), 914–923.

7.Shalini, A., & Logaraj, M. (2021). Prevalence and factors influencing self-medication among urban adults in Tamil Nadu: A community-based study. Indian Journal of Public Health Research & Development, 12(1), 67–73.

8.Vincent, A., & James, T. (2019). Self-medication practices among medical and paramedical students in a tertiary care institution. International Journal of Medical Science and Public Health, 8(12), 1000–1005.

9.Kumar, V., Mangal, A., Yadav, G., Raut, D., & Singh, S. (n.d.). Prevalence and pattern of self-medication in an urban area of Delhi, India. Medical Journal of Dr. D.Y. Patil Vidyapeeth.

10.Patil, S. B., Kadam, A., & Waghule, M. V. (2019). Self-medication practices in rural area of Pune, Maharashtra: A cross-sectional study. National Journal of Community Medicine, 10(3), 123–126.

11.Rahimisadegh, R., Sharifi, N., Rostayee, Z., & Asadi, R. (2021). Knowledge and practice of self-medication among university students in Jahrom, Iran. International Journal of Health Sciences, 15(6), 27–34.

12.Sharma, K., Sharma, S. K., Gaur, R., Mudgal, S. K., Gupta, P., & Sharma, M. (2019). Self-medication with antibiotics among undergraduate nursing students: A cross-sectional study at AIIMS, Rishikesh. Nursing Journal of India, 110(9), 212–216.

13.Gupta, S., Khajuria, K., Bhat, N. K., Khajuria, V., & Mehra, A. (2019). Knowledge, attitude and practice of self-medication among undergraduate medical students in Jammu. International Journal of Community Medicine and Public Health, 6(2), 732–737.

16.Garg, N., Singh, T. G., Arora, A., Arora, G., & Kaur, A. S. (2018). Self-medication among rural youth near Chitkara University, Punjab. Journal of Drug Delivery and Therapeutics, 8(6-s), 209–213.

18.Doomra, R., & Gupta, S. K. (2002). Adverse drug reactions in various clinical departments at AIIMS, New Delhi: A one-year study. Indian Journal of Pharmacology, 34(3), 144–147.

19.Rani, R., & Sharma, M. (2021). Effectiveness of educational intervention on self-medication knowledge among adults in Haryana: A quasi-experimental study. Journal of Education and Health Promotion, 10, 231.

20.Nair, R., & Joseph, L. (2020). Effect of health education on knowledge regarding antibiotic use among adults in Ernakulam, Kerala. International Journal of Community Medicine and Public Health, 7(9), 3563–3567.

21.Verma, S., & Mishra, N. (2020). Effectiveness of an educational program on knowledge and practice regarding self-medication among adults in Lucknow. Indian Journal of Health and Wellbeing, 11(5), 237–242.

22.Joshi, A., & Ramesh, L. (2019). Impact of health education on awareness of self-medication among adults in Bengaluru. Journal of Family Medicine and Primary Care, 8(6), 1957–1961.

23.Patel, H., & Shah, N. (2021). Effectiveness of educational intervention on rational use of medicine among adults in Ahmedabad. National Journal of Community Medicine, 12(2), 87–92.

 

 

 
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