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Public trial
 

                                        

                    

                        

                            

                            

                        

                        

                            

                                
RBR-6srbb6p Fenugreek extract topical gel to treat scally skin disease 


                                Date of registration:
                                
                                    10/30/2025                                    (mm/dd/yyyy)
                                
                                

                                Last approval date :
                                
                                    10/30/2025                                    (mm/dd/yyyy)
                                
                                
Study type:


                                
Interventional


                                
 


                                
 


                                
Scientific title:


                                

                                                                        

                                        
en

                                        
Clinical and biochemical impact of fenugreek (trigonella foenum  graecum) seeds on Insulin resistance in psoriatic patients visiting tertiary care hospitals of Rawalpindi

                                        

                                        
pt-br

                                        
Impacto clínico e bioquímico das sementes de feno-grego (Trigonella foenum graecum) na resistência à insulina em pacientes com psoríase atendidos em hospitais de atendimento terciário de Rawalpindi

                                        

                                        
es

                                        
Clinical and biochemical impact of fenugreek (trigonella foenum  graecum) seeds on Insulin resistance in psoriatic patients visiting tertiary care hospitals of Rawalpindi

                                        
                                


                                
 



                                
Trial identification

                                
    
                                    
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                                        UTN code: 
                                        U1111-1328-0276
                                    
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    Public title:
    
                                        
    
                                                                                        
    
                                                    
    en
    
                                                    
    Fenugreek extract topical gel to treat scally skin disease 
    
                                                
    
                                                    
    pt-br
    
                                                    
    Gel tópico de extrato de feno-grego para tratar doenças de pele escamosa
    
                                                
                                            
    
                                    
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    Scientific acronym:
    
                                        
    
                                                                                                                                
    
                                    
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    Public acronym:
    
                                        
    
                                                                                                                                
    
                                    
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                                        Secondaries identifiers:
                                                                                                                            
      
                                                
    • 
                                                    07
      
                                                    Issuing authority:
                                                    Research Ethics Committee of Islamia College Peshawar CEP code dated 16-12-2024, reference: 07/chem
                                                
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                                                    N/A
      
                                                    Issuing authority:
                                                    No CAAE code available; ethical approval obtained from study approved by the  Islamia College Peshawar
                                                
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Sponsors

                                
    
                                    
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                                        Primary sponsor:
                                        National University of Medical Sciences Rawalpindi Pakistan
                                    
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                                        Secondary sponsor:
                                                                                                                                                                                                            
      
                                                
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                                                    Institution:
                                                    Islamia College University Peshawar
                                                
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                                        Supporting source:
                                                                                                                            
      
                                                
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                                                    Institution:
                                                    National University of Medical Sciences Rawalpindi Pakistan
                                                
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Health conditions

                                
    
                                    
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    Health conditions:
    
                                        
    
                                                                                        
    
                                                
    en
    
                                                
    Psoriasis 
    
                                                
    
                                                
    pt-br
    
                                                
    Psoríase 
    
                                                
                                            
    
                                    
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    General descriptors for health conditions:
    
                                        
    
                                                
    en
    
                                                
    
                                                    L30.9
                                                    Dermatitis
                                                
    
                                                
    
                                                
    pt-br
    
                                                
    
                                                    L30.9
                                                    Dermatite
                                                
    
                                                
                                                                                    
     
    
                                    
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    Specific descriptors:
    
                                        
    
                                                
    en
    
                                                
    
                                                    L40
                                                    Psoriasis
                                                
    
                                                
    
                                                
    pt-br
    
                                                
    
                                                    L40
                                                    Psoríase
                                                
    
                                                
                                            
     
    
                                    
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Interventions

                                
    








                                    
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    Interventions:
    
                                        
    
                                                                                        
    
                                                
    en
    
                                                
    The intervention involves topical application of a 5% fenugreek (Trigonella foenum-graecum) seed extract gel for the management of mild to moderate psoriasis. A total of 200 participants will be enrolled, including 100 diabetic and 100 non-diabetic participants. All patients will receive a topical fenugreek nano-emulsion gel. The gel will be applied twice daily to the affected psoriatic skin areas for a period of 8 weeks. Each participant will receive detailed instructions regarding the quantity and method of gel application, skin hygiene, and adherence monitoring. Clinical evaluation and safety assessments will be performed at baseline, week 4, and week 8 using standard psoriasis severity scales and photographs for comparison between the two groups
    
                                                
    
                                                
    pt-br
    
                                                
    A intervenção envolve a aplicação tópica de um gel de extrato de semente de feno-grego (Trigonella foenum-graecum) a 5% para o tratamento da psoríase leve a moderada. Serão incluídos 200 participantes, incluindo 100 diabéticos e 100 não diabéticos. Todos os pacientes receberão um gel tópico de nanoemulsão de feno-grego. O gel será aplicado duas vezes ao dia nas áreas afetadas da pele psoriática por um período de 8 semanas. Cada participante receberá instruções detalhadas sobre a quantidade e o método de aplicação do gel, higiene da pele e monitoramento da adesão. A avaliação clínica e as avaliações de segurança serão realizadas no início do estudo, na semana 4 e na semana 8, utilizando escalas padrão de gravidade da psoríase e fotografias para comparação entre os dois grupos.
    
                                                
                                            
    
                                    
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    Descriptors:
    
                                        
    
                                                    
    en
    
                                                    
    
                                                        L40
                                                        Psoriasis 
                                                    
    
                                                    
    
                                                    
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                                                        L40
                                                        Psoríase 
                                                    
    
                                                    
                                            
     
    
                                    
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Recruitment

                                
    
                                    
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                                        Study status:
                                                                                Recruitment completed
                                    
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                                        Countries
                                        
      
                                            
    • Pakistan
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                                        Date first enrollment:
                                        
                                                                                        10/04/2025                                            (mm/dd/yyyy)
                                        

                                    
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                                                Target sample size:
                                                Gender:
                                                Minimum age:
                                                Maximum age:
                                            
    
                                            
    
                                                200
                                                -
                                                18 Y
                                                65 Y
                                            
    
                                            
    
                                    
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    Inclusion criteria:
    
                                        
    
                                                                                        
    
                                                
    en
    
                                                
    Inclusion Criteria, Psoriatic patients;Age between 18 and 65 years; males and females; both diabetic and non-diabetic psoriatic patients


    
                                                
    
                                                
    pt-br
    
                                                
    Critérios de inclusão, pacientes psoriáticos; idade entre 18 e 65 anos; homens e mulheres; pacientes psoriáticos diabéticos e não diabéticos
    
                                                
                                            
    
                                    
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    Exclusion criteria:
    
                                        
    
                                                                                        
    
                                                
    en
    
                                                
    History of alcohol abuse; prior or current use of hepatotoxic medications; any known liver disease; Individuals with clinical evidence of acute hepatitis or positive hepatitis B surface antigen (HBsAg); pregnant or lactating women; individuals with known allergy to fenugreek
    
                                                
    
                                                
    pt-br
    
                                                
    Histórico de abuso de álcool; uso anterior ou atual de medicamentos hepatotóxicos; qualquer doença hepática conhecida; indivíduos com evidência clínica de hepatite aguda ou antígeno de superfície da hepatite B positivo (HBsAg); mulheres grávidas ou lactantes; indivíduos com alergia conhecida ao feno-grego
    
                                                
                                            
    
                                    
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Study type

                                
    
                                    
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    Study design:
    
                                        
    
                                                                                    
    
                                    
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                                                    Expanded access program
                                                    Purpose
                                                    Intervention assignment
                                                    Number of arms
                                                    Masking type
                                                    Allocation
                                                    Study phase
                                                
    
                                                
                                            
                                            
    
                                                1
                                                Treatment
                                                Single-group
                                                1
                                                Open
                                                Non-randomized-controlled
                                                2
                                            
    
                                                
                                        
    
                                    
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Outcomes

                                
    
                                    
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    Primary outcomes:
    
                                        
    
                                                    
    en
    
                                                    
    
                                                        The study is expected to show that the 5% fenugreek (Trigonella foenum-graecum) topical gel reduces psoriatic lesion area by approximately 40–60% after 8 weeks of treatment, with a marked decrease in redness, scaling, and itching. It is anticipated that over 70% of participants will experience at least a moderate improvement in their Psoriasis Area and Severity Index (PASI) score, and 80% will report enhanced comfort and quality of life. The topical formulation is expected to demonstrate excellent skin tolerance, with no serious local or systemic adverse reactions observed during the treatment period
                                                    
    
                                                    
    
                                                    
    pt-br
    
                                                    
    
                                                        Espera-se que o estudo demonstre que o gel tópico de feno-grego (Trigonella foenum-graecum) a 5% reduz a área da lesão psoriática em aproximadamente 40 a 60% após 8 semanas de tratamento, com redução acentuada da vermelhidão, descamação e coceira. Prevê-se que mais de 70% dos participantes apresentarão pelo menos uma melhora moderada na pontuação do Índice de Área e Gravidade da Psoríase (PASI), e 80% relatarão melhora no conforto e na qualidade de vida. Espera-se que a formulação tópica demonstre excelente tolerância cutânea, sem reações adversas locais ou sistêmicas graves observadas durante o período de tratamento
                                                    
    
                                                    
                                            
     
    
                                    
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    Secondary outcomes:
    
                                        
    
                                                
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                                                    No secondary outcome.
                                                
    
                                                
    
                                                
    pt-br
    
                                                
    
                                                    Nenhum resultado secundário.
                                                
    
                                                
                                            
     
    
                                    
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Contacts

                                
    

                                    
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                                        Public contact

                                        
      
                                                                                            
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                                                    Full name:
                                                    Bushra   Bilal
                                                
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                                                            Address:
                                                            The Mall rawalpindi, Pakistan - 46000
                                                        
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                                                            City: 
                                                            Rawalpindi / Pakistan
                                                        
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                                                            Zip code:
                                                            46000
                                                        
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                                                    Phone:
                                                    +923005391081
                                                
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                                                    Email:
                                                    
                                                
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                                                    Affiliation:
                                                    National University of Medical Sciences Rawalpindi Pakistan
                                                
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                                        Scientific contact

                                        
      
                                                                                            
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                                                    Full name:
                                                    Muhammad Asghar Khan
                                                
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                                                            Address:
                                                            The Mall rawalpindi, Pakistan - 46000
                                                        
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                                                            City:
                                                            Rawalpindi / Pakistan
                                                        
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                                                            Zip code:
                                                            46000
                                                        
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                                                    Phone:
                                                    +923339422237
                                                
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                                                    Email:
                                                    
                                                
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                                                    Affiliation:
                                                    National University of Medical Sciences Rawalpindi Pakistan
                                                
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                                        Site contact

                                        
      
                                                                                            
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                                                    Full name:
                                                    Muhammad Asghar Khan
                                                
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                                                            Address:
                                                            The Mall rawalpindi, Pakistan - 46000
                                                        
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                                                            City:
                                                            Rawalpindi / Pakistan
                                                        
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                                                            Zip code:
                                                            46000
                                                        
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                                                    Phone:
                                                    +923339422237
                                                
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                                                    Email:
                                                    
                                                
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                                                    Affiliation:
                                                    National University of Medical Sciences Rawalpindi Pakistan
                                                
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Additional links:

                                                                
                            

                        

                    

                    
 

                            

        

        
 

        
    




            
    

    

        


Total de Ensaios Clínicos 17400.



Existem 8741 ensaios clínicos registrados.



Existem 4819 ensaios clínicos recrutando.



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