A Study on Patients Drop-Out in Unani Pharmacopeial Validation of An Anti-obesity Drug

  • Misbahuddin Azhar Research Officer Scientist-III (U), Regional Research Institute of Unani Medicine (RRIUM), Aligarh
  • Rashidul Islam Ansari Research Officer Scientist-I (U), RRIUM, Aligarh
  • Sadia Ayub Research Officer Scientist-III (Biochem), RRIUM, Aligarh
  • Nighat Anjum Research Officer Scientist-III (U), Central Council for Research in Unani Medicine (CCRUM), Headquarters, New Delhi
  • Anirban Rej Investigator (Statistics), CCRUM, Headquarters, New Delhi
Keywords: Dropout, Unani medical system, clinical pharmacopeial validation, Jawarish Bisbasa


Background: In the clinical research human subject is never in control of researcher, so the rate of dropout in clinical studies is always a major concern. In herbal clinical research the high rate of dropout is always foremost distress for researcher, prolongs the study duration and adds extra financial burden to the project.

Objective of the study: The objective of this study is to find out the possible reasons of dropout in a validation programme.

Materials and methods: All human subjects were informed in advance about the test drug, dosage form, time of administration, number of follow-up and laboratory investigations. The statements/ reasons of leaving of enrolled subjects in validation study on anti-obesity drug Jawarish Bisbasa were recorded in the case record form. At the end of the study all statements were analyzed.

Results: Total 49 patients were dropouts from the study due to various reasons e.g. indiscipline, social injustice, not effective and bad taste of drug, conception, domestic work etc.

Conclusion: Collectively, dropout rates are higher among middle-income group followed by lower middle-income group. The minimum dropout was observed among the socio-economical weak section. As per the occupation house makers are more dropout in comparison to other groups and on other hand, taste, palatability and slow action of formulation are also among them. It is an attempt to understand and explain the direction for future trial design.


1. Anonymous, Unani System of Medicine: The Science of Health and Healing. (Department of AYUSH, Ministry of Health & Family Welfare, Government of India, New Delhi), 2013, 1-4.
2. Anonymous, Annual Report-2017-18. (Central Council for Research in Unani Medicine, New Delhi). 2019.
3. Grover S, Mehra A, Chakrabarti S & Avasthi A, Dropout rates and reasons for dropout from treatment among elderly patients with depression. Journal of Geriatric Mental Health, 5(2) (2018) 121-127.
4. Azhar, MU. Effect of herbal unani formulation on nephrotic syndrome: a case study, Indian Journal of Traditional Knowledge, 2018; 17(4): 807-810.
5. Azhar MU, Ansari RI, Ahmad S. Clinical effect of Barg-e-Jhao (Tamarix articulata vahl.) in hepatosplenomegaly-a case study, International Journal of AYUSH case reports (IJA care), 2019; 3(2): 128-135.
6. Alam MI, Ahsan SM, Salam M, Ahmad T, Azhar MU, Arfeen S. Clinical evaluation of unani drugs Majoon Suranjan, Safoof Suranjan and Raughan Suranjan in Wajaul Mafasil (Rheumatoid Arthritis)-a preliminary study, Hippocratic Journal of Unani Medicine, 2014; 9(4): 73-84.
7. Azhar MU, Ayub S, Anjum N, Ahmad S. Role of dieto-therapy in weight and dyslipidemia management - a case study, International Journal of Scientific Research in Biological Sciences, 2020; 7(1): 17-19.
8. Azhar MU, Ayub S, Anjum N, Ahmad S, Effect of Jawarish Bisbasa on dyslipidemia - a case study” International Journal Of Scientific Research In Biological Sciences, 2020; 7(1): 20-23.
9. Azhar MU, Ahmad Z, Mustehasan. Effect of unani medicine in Iltehab-e-Jild Huzaazi (Seborrheic dermatitis) of head: a case study, International Journal of Scientific Research In Biological Sciences, 2020; 7(2): 41-43.
10. Azhar MU, Ayub S, Mustehasan. Effect of non medicinal therapy of unani medicine in weight and dyslipidemia management” World Journal of Pharmaceutical Research, 2021; 10(1): 1285-1294.
11. Anonymous, National Formulary of Unani Medicine. Vol-II, part-I, (Central Council for Research in Unani Medicine, Department of AYUSH, Ministry of Health & Family Welfare, Government of India), 2006, 98-99.
12. Fernandez-Montalvo J & Goni JJL, Comparison of completers and dropouts in psychological treatment for cocaine addiction. Addiction Research and Theory, 18(4) (2010) 433-441.
13. Gilford DM, The ageing population in the twenty first century, Statistics for health policy, (National Academics Press, USA), 1988.
14. Hu YR & Goldman N, Mortality differentials by marital-status an international comparison. Demography, 27(2) (1990) 233-250.
15. Arpey NC, Gaglioti AH & Rosenbaum ME, How Socioeconomic Status Affects Patient Perceptions of Health Care: A Qualitative Study, Journal of Primary Care & Community Health, 8(3) (2017) 169-175.
16. Hughes JR, Keely JP, Niaura RS, Ossip-Klein DJ, Richmond RL, et al. Measures of abstinence in clinical trials: issues and recommendations. Nicotine & Tobacco Research, 5 (1) (2003) 13-25.
17. O’Hare A, Study suggests that socioeconomic status may affect clinical trial participation. Clin. Invest. 3(3) (2013) 223-226
18. Shah MH, The General Principles of Avicenna’s Canon of Medicine, (Idara Kitab ul Shifa, New Delhi), 2007, 24-35.
19. Ruger JP, Health and social justice, Lancet, 364(9439) (2004) 1075-1080.
20. Mennella JA, Spector AC, Reed DR & Coldwell SE, The Bad Taste of Medicines: Overview of Basic Research on Bitter Taste. ClinTher., 35(8) (2013) 1225-1246.
21. Dag ZO & Dilbaz B, Impact of obesity on infertility in women. J Turk Ger Gynecol Assoc., 16(2) (2015) 111-117.
22. Gaware VM, Parjane SK, Abhijit MN, Pattan SR, Dighe NS, et al. Female infertility and its treatment by alternative medicine: A review. Journal of Chemical and Pharmaceutical Research, 1(1) (2009) 148-162.
23. Al-Inany H, Female infertility. Clin. Evid. (15) (2006) 2465-2487.
24. Bellver J, Melo MA, Bosch E, Serra V, Remohi J, et al. Obesity and poor reproductive outcome: the potential role of the endometrium. Fertil. Steril., 88(2) (2007) 446-451.
25. Lloyd KB & Hornsby LB, Complementary and alternative medications for women's health issues. Nutr. Clin. Pract. 24(5) (2009) 589-608.
26. Perry TE & Hirshfeld-Cytron J, Role of complementary and alternative medicine to achieve fertility in uninsured patients. Obstet. Gynecol. Surv., 68(4) (2013) 305-11.
27. Kashani L & Akhondzadeh S, Female Infertility and Herbal Medicine. Journal of Medicinal Plants, 16(61) (2017) 3-7.
28. Lakshminarayanan S, Role of government in public health: Current scenario in India and future scope. J Family Community Med., 18(1) (2011) 26-30.
29. Basu S, Andrews J, Kishore S, Panjabi R & Stuckler D, Comparative Performance of Private and Public Healthcare Systems in Low- and Middle-Income Countries: A Systematic Review. PLoS Med., 9(6) (2012) e1001244.