Nctid:
NCT06227858
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"QUADRUPLE", "whoMasked"=>["PARTICIPANT", "CARE_PROVIDER", "INVESTIGATOR", "OUTCOMES_ASSESSOR"], "maskingDescription"=>"Randomisation will be processed by computer-generated random sequence number and will be performed by an independent member of the medical support team which will not be involved in the study"}, "primaryPurpose"=>"SUPPORTIVE_CARE", "interventionModel"=>"FACTORIAL", "interventionModelDescription"=>"2 x 2 factorial design"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>106}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"2024-02-10", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-08", "completionDateStruct"=>{"date"=>"2024-08-15", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2024-08-17", "studyFirstSubmitDate"=>"2024-01-17", "studyFirstSubmitQcDate"=>"2024-01-25", "lastUpdatePostDateStruct"=>{"date"=>"2024-08-20", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-29", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-08-15", "type"=>"ACTUAL"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Effect on overall perimenopause clinical symptoms severity", "timeFrame"=>"6-weeks, 12-weeks", "description"=>"Changes in Greene Climacteric Scale (GCS) score"}], "secondaryOutcomes"=>[{"measure"=>"Effect on sleep quality", "timeFrame"=>"6-weeks, 12-weeks", "description"=>"Changes in Pittsburg sleep quality index (PSQI) score"}, {"measure"=>"Effect on mood", "timeFrame"=>"6-weeks, 12-weeks", "description"=>"Changes in Profile of Mood State (POMS) score"}, {"measure"=>"Effect on quality of life", "timeFrame"=>"6-weeks, 12-weeks", "description"=>"Changes in Short Form Health Survey (SF-36) score"}, {"measure"=>"Exploratory measures", "timeFrame"=>"12-weeks", "description"=>"Changes in fasting plasma glucose level"}, {"measure"=>"Exploratory measures", "timeFrame"=>"12-weeks", "description"=>"Changes in gut microbiome (16S RNA Seq)"}, {"measure"=>"Exploratory measures", "timeFrame"=>"12-weeks", "description"=>"Changes in FSH levels"}, {"measure"=>"Exploratory measures", "timeFrame"=>"12-weeks", "description"=>"Changes in LH levels"}, {"measure"=>"Exploratory measures", "timeFrame"=>"12-weeks", "description"=>"Changes in TSH levels"}]}, "oversightModule"=>{"oversightHasDmc"=>true, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Perimenopausal Disorder"]}, "descriptionModule"=>{"briefSummary"=>"The aim of the present study is to assess the effects of a normalised saffron extract supplementation, which is an extract of the flower Crocus sativus, on perimenopausal symptoms.", "detailedDescription"=>"After being informed about the study protocol aim and potential risks, healthy volunteer woman (walk-in outpatients) will undergo a pre-screening to determine eligibility for study entry. At the visit 1, patients who meet the pre-screening criteria will undergo a second screening to confirm their eligibility based on inclusion and exclusion criteria. After signing the inform consent form, patient who meet eligibility criteria will be randomised in a double-blind manner (participants and investigators) in a 1:1 ratio to saffron extract supplementation (15mg, twice daily) or matched placebo (twice daily) for a period of 3-months (12 weeks)."}, "eligibilityModule"=>{"sex"=>"FEMALE", "stdAges"=>["ADULT"], "maximumAge"=>"55 years", "minimumAge"=>"40 years", "genderBased"=>true, "genderDescription"=>"Biologically characterised as Female", "healthyVolunteers"=>true, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Biological Female which identify themselves as Women\n* Aged ≥ 40 years\n* Irregular menstrual cycle for at least 3 months\n* Presenting typical symptoms of perimenopause with GCS score over 20\n* BMI range between 18-35 kg/m2\n* Healthy woman\n\nExclusion Criteria:\n\n* Less than 40 years old\n* Pregnant\n* Diagnosed with diseases related to reproductive system such as PCOS or endometriosis\n* Taking anti-depressant medication or sleeping pills\n* Taking hormonal replacement therapy (HRT)\n* Taking conventional drug treatment or dietary supplementation\n* Having medical history or medical/surgical event in the last 6 months, or has been treated for cancer or any other ongoing treatment for the past 3 months,\n* Current and/or past history of hyper/hypotension, CVD, diabetes, autoimmune diseases, musculoskeletal disorder or endocrine or immunocompromised or neurological or psychological disorders,\n* Being medicated for these conditions,\n* History of allergic reactions to saffron intake,\n* Decisionally challenged subjects or unable to comply to the study\n* Any conditions that could contraindicates the use of saffron\n* Currently smoking or ceased smoking in the past 3 months"}, "identificationModule"=>{"nctId"=>"NCT06227858", "briefTitle"=>"Effects of a Standardised Saffron Extract Supplementation on Symptoms Associated With Perimenopause in Healthy Women", "organization"=>{"class"=>"OTHER", "fullName"=>"Liaquat University of Medical & Health Sciences"}, "officialTitle"=>"Investigation of the Psychological and Physiological Effects of a Standardised Saffron Extract Supplementation on Symptoms Associated to Perimenopause in Healthy Older Women: A Randomised Double-blind, Placebo-Controlled, Parallel-group Clinical Trial", "orgStudyIdInfo"=>{"id"=>"LUMHS/REC/-221"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Saffron extract supplementation (15mg, twice daily)", "description"=>"The experimental group will take a single capsule containing: 15mg of of saffron extract (stigma of the flower Crocus sativus), 340mg of Maltodextrin, encapsulated in hydroxypropyl methyl cellulose (HPMC), twice daily (one morning and one evening after the meal).", "interventionNames"=>["Dietary Supplement: Safr'Inside supplement (Activ'Inside, SAS)"]}, {"type"=>"PLACEBO_COMPARATOR", "label"=>"Control group", "description"=>"The Control group will take a single placebo capsule (matched to the experimental intervention in terms of colours and taste, without the active compounds saffron) twice daily (one morning and one evening after the meal).", "interventionNames"=>["Other: Plcebo"]}], "interventions"=>[{"name"=>"Safr'Inside supplement (Activ'Inside, SAS)", "type"=>"DIETARY_SUPPLEMENT", "description"=>"Dietary supplementation will be taken in addition to habitual diet of the patients", "armGroupLabels"=>["Saffron extract supplementation (15mg, twice daily)"]}, {"name"=>"Plcebo", "type"=>"OTHER", "description"=>"Placebo capsule (matched to the experimental intervention in terms of colours and taste, without the active compounds saffron)", "armGroupLabels"=>["Control group"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"76060", "city"=>"Jāmshoro", "state"=>"Sindh", "country"=>"Pakistan", "facility"=>"Department of Biochemistry, LUMHS", "geoPoint"=>{"lat"=>25.43773, "lon"=>68.28522}}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Liaquat University of Medical & Health Sciences", "class"=>"OTHER"}, "collaborators"=>[{"name"=>"University of East Anglia", "class"=>"OTHER"}, {"name"=>"Activ'inside", "class"=>"INDUSTRY"}], "responsibleParty"=>{"type"=>"SPONSOR"}}}}
