Background:Constipation is a common chronic bowel disorder with an incidence of more than 50％in the elderly population.Complementary and alternative medicine is a cost-effective and satisfactory treat-ment for constipation used widely by the elderly.Objective:This study evaluates the efficacy of an herbal formula made from Foeniculum vulgare Mill.and Rosa damascena for the treatment of constipation in an elderly population and consequent changes to their quality of life.Design,setting,participants and intervention:This double-blind randomized active controlled clinical trial,with parallel group allocation ratio of 1:1,was conducted in a referral clinic in Afzalipour Hospital,affil-iated to Kerman University of Medical Sciences in Kerman,Southeastern Iran.Individuals over 60 years of age,diagnosed with functional constipation(based on the Rome Ⅳ criteria),were included in this study.Participants received a sachet of 10 g F.vulgare and R.damascena(herbal formula group)or polyethylene glycol 4000(PEG 4000 group)with a glass of warm water two times a day for 4 weeks and were followed up for 4 additional weeks.Main outcome measures:Constipation severity,stool consistency,and the quality of life were used as the primary outcomes.Drug side effects were used as a secondary outcome.The outcomes were assessed using the Constipation Assessment Scale,the Bristol Stool Form Scale,and the Patient Assessment of Constipation Quality of Life questionnaire.Results:A total of 25 participants in each group completed the four-week treatment cycle and the eight-week follow-up.At the end of the four-week treatment cycle,all clinical outcomes had significant improvements in both groups(P＜0.05).The analysis of constipation severity(P＜0.001),stool consis-tency(P＜0.001),and the quality of life(P＜0.001)showed significant improvements with fewer side effects(mild diarrhea)and a longer duration of symptom relief in the herbal formula group compared to the PEG 4000 group.Conclusion:Although both interventions significantly improved the treatment outcomes,constipation severity,stool consistency and the quality of life were improved more effectively by the herbal formula than by PEG 4000;however,the mechanism of action is not yet understood.Trial registration:This trial was registered in the Iranian Registry of Clinical Trials(IRCTID:IRCT20200108046056N1).

Gastroenterology and Hepatology Research Center,Kerman University of Medical Sciences,Kerman 7716913555,Iran;Department of Traditional Medicine,School of Persian Medicine,Kerman University of Medical Sciences,Kerman 7716913555,Iran;Student Research Committee,Afzalipour Faculty of Medicine,Kerman University of Medical Sciences,Kerman 7716913555,Iran;Herbal and Traditional Medicines Research Center,Kerman University of Medical Sciences,Kerman 7716913555,Iran;Department of Community Health Nursing,Razi Faculty of Nursing and Midwifery,Kerman University of Medical Sciences,Kerman 7716913555,Iran

[1]Maryam Azimi;Hanieh Niayesh;Mahboobeh Raeiszadeh;Sedigheh Khodabandeh-shahraki-.Efficacy of the herbal formula of Foeniculum vulgare and Rosa damascena on elderly patients with functional constipation:A double-blind randomized controlled trial)[J].结合医学学报（英文版）,2022(03):230-236

Foeniculum,damascena,Afzalipour,affil,iated,sachet,IRCTID,IRCT20200108046056N1

Efficacy,herbal,formula,vulgare,Rosa,elderly,patients,functional,constipation,double,blind,randomized,controlled,trial,Background,Constipation,common,chronic,bowel,disorder,incidence,more,than,population,Complementary,alternative,medicine,cost,satisfactory,used,widely,by,Objective,This,study,evaluates,efficacy,made,from,Mill,treatment,consequent,changes,their,quality,life,Design,setting,participants,active,clinical,parallel,allocation,was,conducted,referral,Hospital,Kerman,University,Medical,Sciences,Southeastern,Individuals,over,years,age,diagnosed,Rome,criteria,were,included,this,Participants,received,polyethylene,glycol,PEG,glass,warm,water,two,times,day,weeks,followed,additional,Main,measures,severity,stool,consistency,primary,outcomes,Drug,side,effects,secondary,assessed,using,Assessment,Scale,Bristol,Stool,Form,Patient,Quality,Life,questionnaire,Results,total,each,completed,four,cycle,eight,At,end,had,improvements,both,groups,analysis,showed,fewer,mild,diarrhea,longer,duration,symptom,relief,compared,Conclusion,Although,interventions,significantly,improved,effectively,however,mechanism,action,not,understood,registration,registered,Iranian,Registry,Clinical,Trials

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