Effects of the Combination of Nigella Sativa and Mefenamic Acid and Mefenamic Acid Alone on the Severity of Postpartum Pain in Multiparous Women: A Double-Blind Clinical Trial

Document Type : Original Article


1 M.Sc. Student in Midwifery, Student Research Committee, School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Tehran, Iran.

2 Instructor, Department of Midwifery and Reproductive Health, Midwifery and Reproductive Health Research Center, School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Tehran, Iran.

3 Assistant Professor, Department of Midwifery and Reproductive Health, Midwifery and Reproductive Health Research Center, School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Tehran, Iran.

4 Professor, Department of Pharmacognosy and Pharmaceutical Biotechnology, School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran.

5 Assistant Professor, Department of Biostatistics, School of Paramedical Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran.


Introduction: Postpartum pain or painful uterine contractions is an important postpartum problem, and its relief could improve breastfeeding and mother-infant interactions. Medicinal herbs could be used to relieve postpartum pain with fewer side-effects and better acceptability compared to chemical medications. The present study aimed to compare the effects of the combination of Nigella sativa (Kalonji) and mefenamic acid and mefenamic acid alone on postpartum pain in multiparous women.
Materials and Methods: This randomized double-blind clinical trial was conducted on 100 multiparous women with natural delivery, who complained of moderate-to-severe postpartum pain in 2017. The women were randomly assigned to two groups of Kalonji-mefenamic acid (n=50) and placebo-mefenamic acid (n=50). Severity of postpartum pain was measured using the visual analogue scale (VAS) two hours after delivery, and mothers with the pain score of ≥4 were enrolled in the study. Women in the intervention group received mefenamic acid capsules (250 mg) with a Kalonji capsule (500 mg), and the control group received mefenamic acid capsules (250 mg) with a placebo. Severity and duration of pain were measured before and one hour after each medication administration using the VAS. Data analysis was performed in SPSS version 22 using independent and paired t-test, Chi-square, and Mann-Whitney U test. P-value of less than 0.05 was considered statistically significant.
Results: Severity of postpartum pain reduced more rapidly and significantly in the Kalonji-mefenamic acid group compared to the placebo-mefenamic acid group (P<0.001).
Conclusion: According to the results, combination of Kalonji and mefenamic acid could be used as an effective herbal remedy in the women with postpartum pain.


  1. Deussen AR, Ashwood P, Martis R. Analgesia for relief of pain due to uterine cramping/involution after birth. New York: The Cochrane Library; 2011.
  2. Cunningham F, Leveno K, Bloom S, Spong CY, Dashe J. Williams obstetrics. 24th ed. New York: McGraw-Hill; 2014.
  3. Tafazoli M, Khadem Ahmadabadi M, Asili J, Esmaili H. Comparison the effects of cuminum and mefenamic acid on after pains in multiparous women. Iran J Obstet Gynecol Infertil 2013; 16(75):1-11. (Persian).
  4. Holdcroft A, Snidvongs S, Cason A, Doré CJ, Berkley KJ. Pain and uterine contractions during breast feeding in the immediate post-partum period increase with parity. Pain 2003; 104(3):589-96.
  5. Holdcroft A. Postpartum lower abdominal pain. Curr Rev Pain 1999; 3(2):137-43.
  6. Jangsten E, Bergh I, Mattsson LÅ, Hellström AL, Berg M. Afterpains: a comparison between active and expectant management of the third stage of labor. Birth 2011; 38(4):294-301.
  7. Pourmaleky S, Najar S, Montazery S, Haghighizadeh MH. Comparison between the effects of Zintoma (Ginger) and Mefenamic acid on after pain during postpartum in multiparous women. Iran J Obstet Gynecol Infertil 2013; 16(79):18-25. (Persian).
  8. Saket M. The effect of low dose combination of morphine and uncontrolled physical stress on the development of fetal cerebellum of wistar rats. [Master Thesis]. Tehran: Islamic Azad University; 2010. (Persian).
  9. Lewallen LP, Dick MJ, Wall Y, Zickefoose KT, Hannah SH, Flowers J, et al. Toward a clinically useful method of predicting early breast-feeding attrition. Appl Nurs Res 2006; 19(3):144-8.
  10. Matteson P. Women's health during the childbearing years: a community-based approach. Missouri: Mosby; 2001.
  11. Dox IG, Melloni JL, Sheld HH. Melloni's illustrated dictionary of obstetrics and gynecology. London: Taylor & Francis; 2000.
  12. Pillitteri A. Maternal & child health nursing: care of the childbearing & childrearing family. Philadelphia: Lippincott Williams & Wilkins; 2010.
  13. Yeh YC, Chen SY, Lin CJ, Yeh HM, Sun WZ. Differential analgesic effect of tenoxicam on post-cesarean uterine cramping pain between primiparous and multiparous women. J Formos Med Assoc 2005; 104(9):647-51.
  14. Dumont AS, Verma S, Dumont RJ, Hurlbert RJ. Nonsteroidal anti-inflammatory drugs and bone metabolism in spinal fusion surgery: a pharmacological quandary. J Pharmacol Toxicol Methods 2000; 43(1):31-9.
  15. Katzung BG, Masters SB, Trevor AJ. Basic & clinical pharmacology. New York: McGraw-Hill Medical; 2016.
  16. Kanwar MS. Herbal alternatives to drugs in pain management. California: MPA Media; 2011.
  17. Fang YC, Huang HC, Chen HH, Juan HF. TCMGeneDIT: a database for associated traditional Chinese medicine, gene and disease information using text mining. BMC Complement Altern Med 2008; 8(1):58.
  18. Hamilton JL, Roemheld-Hamm B, Young DM, Jalba M, DiCicco-Bloom B. Complementary and alternative medicine in US family medicine practices: a pilot qualitative study. Altern Ther Health Med 2008; 14(3):22-7.
  19. Qi Z, Kelley E. The WHO traditional medicine strategy 2014–2023: a perspective. Science 2014; 346(6216):S5-6.
  20. Ahmad A, Husain A, Mujeeb M, Khan SA, Najmi AK, Siddique NA, et al. A review on therapeutic potential of Nigella sativa: A miracle herb. Asian Pac J Trop Biomed 2013; 3(5):337-52.
  21. Aqel M, Shaheen R. Effects of the volatile oil of Nigella sativa seeds on the uterine smooth muscle of rat and guinea pig. J Ethnopharmacol 1996; 52(1):23-6.
  22. ElTahir K, Al-Tahir A, Ageel A. Pharmacological studies on sesame and Nigella sativa fixed oils: effect on the sensitivities of the adrenoreceptors, baroreceptors, platelets and the uterus of the rat. Saudi Pharmaceut J 1999; 7(4):205-15.
  23. Boskabady MH, Javan H, Sajady M, Rakhshandeh H. The possible prophylactic effect of Nigella sativa seed extract in asthmatic patients. Fundam Clin Pharmacol 2007; 21(5):559-66.
  24. Abdel-Fattah AM, Matsumoto K, Watanabe H. Antinociceptive effects of Nigella sativa oil and its major component, thymoquinone, in mice. Eur J Pharmacol 2000; 400(1):89-97.
  25. Ozgoli G, Khodadadie A, Sheikhan Z, Jambarsang S, Mojab F, Taleb S. Comparison of efficacy between herbal capsule of anise and mefenamic acid on after-pain. J Med Plants 2017; 2(62):38-49. (Persian)
  26. Shadipour M, Simbar M, Salamzadeh J, Nasire N. A comparative study on the effects of Menstrogol and Mefenamic acid on postpartum after-pain. Iran South Med J 2014; 16(6):401-9. (Persian)
  27. Abedian Z, Rezvani Fard M, Asili J, Esmaeili H, Dadgar S. Comparison of the Effect of chamomile matricaria and mefenamic acid capsules on postpartum hemorrhage in women with postpartum pain. Iran J Obstet Gynecol Infertil 2016; 19(14):1-8. (Persian).
  28. Hawker GA, Mian S, Kendzerska T, French M. Measures of adult pain: visual analog scale for pain (vas pain), numeric rating scale for pain (nrs pain), mcgill pain questionnaire (mpq), short‐form mcgill pain questionnaire (sf‐mpq), chronic pain grade scale (cpgs), short form‐36 bodily pain scale (sf‐36 bps), and measure of intermittent and constant osteoarthritis pain (icoap). Arthritis Care Res 2011; 63(S11):S240-52.
  29. Farrar JT, Troxel AB, Stott C, Duncombe P, Jensen MP. Validity, reliability, and clinical importance of change in a 0-10 numeric rating scale measure of spasticity: a post hoc analysis of a randomized, double-blind, placebo-controlled trial. Clin Ther 2008; 30(5):974-85.
  30. McMahon SB, Koltzenburg M, Tracey I, Turk D. Wall & melzack's textbook of pain e-book. New York: Elsevier Health Sciences; 2013.
  31. Hamill RJ, Rowlingson JC. Handbook of critical care pain management. New York: McGraw-Hill, Health Professions Division; 1994. P. 20-1.
  32. Fleming T. PDR for herbal medicines. Montvale, NJ: Medical Economics; 2000. P. 232-3.
  33. Ghalandari S, Kariman N, Sheikhan Z, Mojab F, Mirzaei M, Shahrahmani H. Effect of hydroalcoholic extract of capsella bursa pastoris on early postpartum hemorrhage: a clinical trial study. J Alternat Complement Med 2017; 23(10):794-9.
  34. Kunwar RM, Bussmann RW. Ethnobotany in the Nepal Himalaya. J Ethnobiol Ethnomed 2008; 4:24.
  35. Qureshi R, Waheed A, Arshad M, Umbreen T. Medico-ethnobotanical inventory of tehsil Chakwal, Pakistan. Pak J Bot 2009; 41(2):529-38.
  36. Kheiriyat F, Tadayon Najafabadi M, Mousavi P, Haghighizadeh H, Namjuyan F. Effect of Dill essence and mefenamic acid on postpartum pain. Iran J Obstet Gynecol Infertil 2016; 19(4):8-16. (Persian).
  37. Boskabady MH, Keyhanmanesh R, Saadatloo MA. Relaxant effects of different fractions from Nigella sativa L. on guinea pig tracheal chains and its possible mechanism (s). Indian J Exp Biol 2008; 46(12):805-10.
  38. Parvardeh S, Fatehi M. Inhibitory effects of thymoquinone, the major component of Nigella sativa L. seeds, on spontaneous and evoked contractions of guinea pig isolated ileum. J Med Plants 2007; 3(23):29-39.
  39. Jafarnejad F, Mohanazadeh Falahieh F, Rakhshandeh H, Shakeri MT. Comparison of the effect of nigella sativa and mefenamic acid on menstrual hemorrhage in the students with primary dysmenoreha. Iran J Obstet Gynecol Infertil 2016; 18(185):10-5. (Persian).
  40. Parsa L, Ozgoli G. A systematic on the medicinal plants used in the treatment of postpartum pain in Iran. Iran J Obstet Gynecol Infertil 2017; 20(5):84-96. (Persian).