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Submitted: 06 Aug 2020
Accepted: 03 Nov 2020
ePublished: 28 Nov 2020
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Immunopathol Persa. 2022;8(1): e10.
doi: 10.34172/ipp.2022.10
  Abstract View: 37
  PDF Download: 18

Original

Cotoneaster manna oral drop for the management of neonatal hyperbilirubinemia; a randomized, double-blinded and placebo controlled clinical trial

Moloud Fakhri 1,2 ORCID logo, Roya Farhadi 3 * ORCID logo, Mohammad Azadbakht 1,4,5 * ORCID logo, Jafar Akbari 6 ORCID logo, Seyede Seddigheh Yousefi 1 ORCID logo, Nouraldin Mousavinasab 7 ORCID logo, Ali Davoodi 3 ORCID logo

1 Traditional and Complementary Medicine Research Center, Addiction Institute, Mazandaran University of Medical Sciences, Sari, Iran
2 Faculty of Medicine, Mazandaran University of Medical Sciences, Sari, Iran
3 Department of Pediatrics, Faculty of Medicine, Bouali Hospital, Mazandaran University of Medical Sciences, Sari, Iran
4 Department of Pharmacognosy, Faculty of Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran
5 The Health of Plant and Livestock Products Research Center, Mazandaran University of Medical Sciences, Sari, Iran
6 Department of Pharmaceutics, Faculty of Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran
7 Department of Biostatistics, Faculty of Health, Mazandaran University of Medical Sciences, Sari, Iran
*Correspondence to Mohammad Azadbakht, Email: Azadbakht110@gmail.com, mazadbakht@mazums.ac.ir

Abstract

Introduction: Neonatal hyperbilirubinemia is a common physiologic condition, which is occurred in early days after birth with an estimated incidence of about 50% in term neonates.

Objectives: The aim of this study was to evaluate the effect of Cotoneaster nummularioides manna on reducing neonatal total serum bilirubin (TSB) levels, and shortening hospitalization period.

Patients and Methods: One hundred breast-fed term neonates with hyperbilirubinemia were randomly assigned to the intervention group or control group. The Newborns of the intervention group were received Cotoneaster manna drop in the dosage of 1 g/d divided into three doses every 8 hours for at least 3 days and the control group received placebo drops. Total serum bilirubin levels were measured at baseline, at 12, 24 hours and then daily through hospitalization days (day 9). Secondary outcome (discharge from hospital, TSB <10 mg/dL) was also documented with risk ratio calculation.

Results: TSB levels were declined in both groups; however, this was more prominent in the manna group than the placebo group. The greatest difference of mean TSB levels between the intervention and control groups was seen on days two (10.01 versus 13.04 mg/dL; mean difference [95% CI]: - 3.03 [-3.60 to -2.46]; P<0.001). On day four, significantly more newborns in the intervention group versus the control group were discharged (70% versus 6.1%; risk ratio = 11.43, 95% CI= 3.76, 34.74). No major side effects were recorded in both groups.

Conclusion: Cotoneaster nummularioides manna drop combined with phototherapy was superior to the control group in reducing TSB levels and reaching this observation more rapidly and shortening hospitalization period with no major side effects.

Trial Registration: The trial protocol was approved by the Iranian Registry of Clinical trials (identifier: IRCT20160531028188N4; https://en.irct.ir/trial/27765, ethical code #IR.MAZUMS.REC.1394.1316).

Keywords: Cotoneaster manna, Neonatal jaundice, Bilirubin, Medicinal plants
Citation: Fakhri M, Farhadi R, Azadbakht M, Akbari J, Yousefi SS, Mousavinasab N, Davoodi A. Cotoneaster manna oral drop for the management of neonatal hyperbilirubinemia; a randomized, double-blinded and placebo controlled clinical trial. Immunopathol Persa. 2022;8(1):e10. DOI:10.34172/ ipp.2022.10.
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