Ginseng-notoginseng Containing Supplement for Chronic Fatigue
Efficacy and Safety of Ginseng-notoginseng Containing Supplement on Chronic Fatigue in Adults: A Randomized Waitlist-controlled Trial
This study aims to find out whether a dietary supplement containing ginseng and notoginseng (GIN-201) can safely reduce persistent fatigue in adults. Chronic fatigue is a lasting feeling of tiredness that rest does not relieve which affects about 10% of adults in Hong Kong and can harm sleep, thinking, and quality of life. Ginseng and notoginseng are traditional Chinese medicine herbs thought to boost energy, and early research suggests they may help with fatigue, but their combined effect has not been tested in people.
The study will recruit 130 adults aged 30 to 75 who report fatigue and poor sleep. Participants will be randomly assigned to one of two groups: one group takes GIN-201 capsules (4 per day) for 6 weeks, while the other group waits 6 weeks before starting the same supplement. Both groups will then be followed for another 6 weeks. Fatigue, sleep, mood, quality of life, and sexual/menopausal symptoms will be measured with standard questionnaires, and blood tests will check for markers of inflammation, stress, aging, and mitochondrial health, as well as for safety.
The main question the study is trying to answer is: Does taking GIN-201 for 6 weeks reduce fatigue more than no treatment, and is it safe? The researchers hypothesize that GIN-201 will reduce fatigue in adults with persistent fatigue. The study will also explore whether changes in blood biomarkers are linked to any benefits, which may help identify who is most likely to respond to the supplement.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Yunqing Xun
- Número de telefone: +852 5229 5427
Estude backup de contato
- Nome: Tung Leong Fong
- Número de telefone: +852 56604020
- E-mail: u3557512@connect.hku.hk
Locais de estudo
-
-
Abia State
-
Calabar, Abia State, Nigéria, 540221
- Specialist Clinical Centre for Teaching and Research, School of Chinese Medicine, The University of Hong Kong
-
Contato:
- TUNG LEONG FONG
- Número de telefone: +852 5660 4020
- E-mail: tlfong@hku.hk
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Ages 30 to 75 years
- Self-reported fatigue with Chalder Fatigue Scale ≥4
- Self-reported poor sleep quality with Pittsburgh Sleep Quality Index >5
- Able to complete an online validated fatigue survey, 6-week intervention, and all follow-ups
Exclusion Criteria:
- Diagnosed with dementia or major psychiatric disorder
- Sleep apnea requiring CPAP
- Current participation in other trials
- Unable to comply with study procedures and give informed consent
- Known allergy to study product or its excipients
- Abnormal heart, liver or renal function
- Not pregnant or planning pregnancy within 6 months
- Using anticoagulants
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: GIN-201 supplement
Participants receive Ginseng-notoginseng Containing Supplement (GIN-201) in 4 capsules, once per day, for 6 weeks, according to the manufacturer's guidelines, followed by a 6-week follow-up. |
GIN-201 is a capsule supplement produced via microbial fermentation technology in a GMP-certified Hong Kong facility, converting ginseng and notoginseng into a highly bioavailable extract; It is reported to support mitochondrial function, DNA repair, NAD+ elevation, and antioxidant defense. Participants take 4 capsules orally once daily for 6 weeks, followed by a 6-week follow-up. |
|
Sem intervenção: waitlist group
The waiting list control group will wait for 6 weeks after the randomization, and then start to receive GIN-201 in 4 capsules, once per day, for 6 weeks, followed by a 6week follow-up. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Chalder Fatigue Score (CFS)
Prazo: From enrollment to 6 weeks
|
Bimodally scored 0-4 on an 11-item scale; higher scores indicate greater fatigue. |
From enrollment to 6 weeks
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Chalder Fatigue Score (CFS)
Prazo: From enrollment to 6 weeks and 12 weeks
|
Bimodally scored 0-4 on an 11-item scale; higher scores indicate greater fatigue. |
From enrollment to 6 weeks and 12 weeks
|
|
Fatigue Severity Score (FSS)
Prazo: From enrollment to 6 weeks and 12 weeks
|
Likert score 1-7 on a 9-item scale; higher scores indicate more severe fatigue. |
From enrollment to 6 weeks and 12 weeks
|
|
PROMIS Short Form Fatigue 7A
Prazo: From enrollment to 6 weeks and 12 weeks
|
5-point Likert scale across 7 items; higher scores indicate greater fatigue. |
From enrollment to 6 weeks and 12 weeks
|
|
36-Item Short-Form Health Survey (SF-36)
Prazo: From enrollment to 6 weeks and 12 weeks
|
Range 0-100; higher scores indicate better health status. |
From enrollment to 6 weeks and 12 weeks
|
|
Hospital Anxiety and Depression Scale (HADS)
Prazo: From enrollment to 6 weeks and 12 weeks
|
Range 0-21; higher scores indicate more severe symptoms. |
From enrollment to 6 weeks and 12 weeks
|
|
Pittsburgh Sleep Quality Index (PSQI)
Prazo: From enrollment to 6 weeks and 12 weeks
|
Range 0-21; higher scores indicate worse sleep quality. |
From enrollment to 6 weeks and 12 weeks
|
|
Brief Male Sexual Function Inventory (BMSFI) / Menopause Rating Scale (MRS)
Prazo: From enrollment to 6 weeks and 12 weeks
|
BMSFI: 11-item in 5 divisions; higher score indicates more satisfied sexual function (men). MRS: Likert score 0-4 for 11 items; higher indicates severer menopause symptoms (women). |
From enrollment to 6 weeks and 12 weeks
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- UW-26-299
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
De-identified individual participant data underlying the results reported in the primary study publication will be shared, together with a data dictionary. Shared data will include participant characteristics, treatment allocation, Chalder Fatigue Score and other fatigue questionnaire scores, quality-of-life (SF-36), psychological (HADS), sleep (PSQI), and sexual/menopausal symptom (BMSFI/MRS) scores, biomarker results (inflammation, stress, neurotrophic, aging, and mitochondrial health), adherence data, and adverse event data used in the published analyses. Direct identifiers and the participant identification linkage file will not be shared. Access will be provided to qualified researchers following approval of a research proposal and execution of a data use agreement. Sharing will be subject to any required Institutional Review Board (IRB) and institutional approvals and must be consistent with participant consent.
Prazo de Compartilhamento de IPD
De-identified individual participant data and the selected supporting documents will be available from publication of the primary study results until five years after study completion.
Critérios de acesso de compartilhamento IPD
De-identified individual participant data underlying the published results, the data dictionary, and the selected supporting documents will be available to qualified researchers upon reasonable request. Requests should be submitted by email to the principal investigator and include a methodologically sound research proposal and statistical analysis plan. The principal investigator will review requests for scientific merit, feasibility, and consistency with participant consent and institutional requirements. Approved researchers may use the data only for analyses specified in the approved proposal. Access will require a signed data use agreement and any necessary IRB and institutional approvals. Data will be provided through secure transfer.
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
- ANALYTIC_CODE
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .