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.
研究概览
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Yunqing Xun
- 电话号码：+852 5229 5427
研究联系人备份
- 姓名：Tung Leong Fong
- 电话号码：+852 56604020
- 邮箱：u3557512@connect.hku.hk
学习地点
-
-
Abia State
-
Calabar、Abia State、尼日利亚、540221
- Specialist Clinical Centre for Teaching and Research, School of Chinese Medicine, The University of Hong Kong
-
接触：
- TUNG LEONG FONG
- 电话号码：+852 5660 4020
- 邮箱：tlfong@hku.hk
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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
学习计划
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：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. |
|
无干预：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. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Chalder Fatigue Score (CFS)
大体时间：From enrollment to 6 weeks
|
Bimodally scored 0-4 on an 11-item scale; higher scores indicate greater fatigue. |
From enrollment to 6 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Chalder Fatigue Score (CFS)
大体时间：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)
大体时间：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
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他研究编号
- UW-26-299
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
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.
IPD 共享时间框架
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.
IPD 共享访问标准
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.
IPD 共享支持信息类型
- 研究方案
- 树液
- 分析代码
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.