AI evidence summary · MVP
Ashwagandha for Sleep Quality
AI preliminary evidence assessment
BB 級｜AI 整體初步評級
This preliminary assessment is currently available in Traditional Chinese.
Exact question對有睡眠困擾或研究明確報告睡眠結果的成人，口服單一印度人參（Withania somnifera）製劑相較安慰劑或其他條件相同的同期對照，是否改善睡眠品質、睡眠症狀及睡眠測量結果，並有哪些不良反應？健康者、壓力困擾與確診失眠者及不同製劑分層呈現。
已驗證評讀顯示研究結果偏向支持介入效果，但仍有重要不確定性。主要限制包括：原中性檢索121筆已完整取得並篩選，原紀錄維持15納入、65背景、36排除、5未確定；依來源角色修訂為14療效、71背景，未增加檢索紀錄。兩篇早期全文升級來源原已存在；14份療效報告對應9個已確認研究事件，另5個研究事件身分待處理；不同註冊事件不保證個別參與者完全不重疊。原5份未確定報告保留背景，不當作陰性票。
Additional assessment reasons await presentation; see the research results below.
Limitations affecting this assessment
- 本次獨立判斷為有限但具一致方向的短期療效支持；B為初步編輯分類，並非正式GRADE。整體確定性受小型試驗、完成者分析、多重終點、報告矛盾及來源存取限制影響。
- 原121筆已完整擷取及篩選，原分類15納入／65背景／36排除／5不確定維持不變；依原文製劑修訂為14直接療效報告、71背景。31728244及32021735原已存在，取得摘錄並非新增紀錄。
- 來源角色整理為9個確認試驗事件、5份暫留報告；不同註冊事件不能證明個別受試者絕不重疊，無法提供可靠的全來源去重總人數。多臂、重複報告與綜述不增加獨立群體。
- 全文摘錄不等同完整論文審查；39954269及35984871的更正內容未取得。15937373、34553463及無結果可讀的36516058、37071616、5737360保留臨床背景與未知適用性，不作陰性票或新證實合格研究。
- 根、根葉、緩釋及不同標準化製劑不可按毫克直接互換；多數研究僅約4至12週，停藥後持續效益、罕見傷害及長期安全未確立。
- 本次外部證據資料庫資料缺失，系統性回顧也未被納入該計分欄位；兩個欄位各依原規則採0.5中性政策值。這些值不是研究支持票，也不表示文獻中沒有系統性回顧。
- 原中性檢索121筆已完整取得並篩選，原紀錄維持15納入、65背景、36排除、5未確定；依來源角色修訂為14療效、71背景，未增加檢索紀錄。兩篇早期全文升級來源原已存在。
- 14份療效報告對應9個已確認研究事件，另5個研究事件身分待處理；不同註冊事件不保證個別參與者完全不重疊。原5份未確定報告保留背景，不當作陰性票。
- 全文節錄不等於完整論文審查；只用各封存來源支持的人數與類型，多臂、重複時間點及綜述不增加獨立群體。
- 根萃取物、根葉製劑、緩釋製劑與其他標準化製劑不可按毫克直接互換；健康、壓力、老年、失眠、孕期與停經後族群分層解讀。
- 早期失眠報告的人數及顯著性敘述與表格不一致；女性足球員報告和大學生報告的原更正通知內文未提供，仍限制解讀。
- 短期未報不良事件不證明長期安全；孕期研究未測胎兒健康或長期母胎結果。
- 混方牛奶研究實驗臂另含香蜂草、B6及B9；其VAS及ISI改善、PSQI組間無顯著差異與3例腸胃事件僅保留為混方背景。
- 保留14份臨床研究報告，其中9個群體已確認、5份報告的獨立性仍待確認；所有報告均供臨床評讀，現行計分只使用已確認群體的研究列，亦影響資助比例分母。群體數與人數合計不代表已證明參與者完全不重疊。
Research results
Findings are currently provided in Traditional Chinese; source excerpts retain their original language.
Main result 1
10 週10週SOL、SE、PSQI及七點主觀睡眠品質支持改善；Table 2的TST與WASO均p=0.076，TIB p=0.567，晨間清醒p=0.175，不能依正文概括為所有指標顯著。
Applicability assessment: 確診失眠成人，安慰劑對照且評估睡眠結果。
- Population
- 失眠及焦慮患者
- Intervention
- 口服印度人參根萃取物膠囊
- Comparator
- 相同外觀澱粉安慰劑；兩組均以牛奶或水服用。
- Outcome
- 匹茲堡睡眠品質指數（PSQI）分數
- Follow-up
- 10 週
- Formulation
- Not established
- Dose
- KSM-66根萃取物300 mg，每日兩次；來源稱withanolides >5%。
Source excerpt: There was a significant decrease in the PSQI scores of the experimental group when compared to the control group.View source
Main result 2
8 週兩劑量七點睡眠量表均優於安慰劑；8週分數為3.79、3.05及4.89，較低表示較佳睡眠。高劑量結果較有利，但不能用焦慮或皮質醇替代睡眠效果。
Applicability assessment: 有壓力困擾的健康成人，單方根萃取物與安慰劑比較睡眠品質。
- Population
- 有壓力困擾的健康成人
- Intervention
- 印度人參根萃取物
- Comparator
- 相同外觀澱粉安慰劑，共同三臂設計。
- Outcome
- 主觀睡眠品質
- Follow-up
- 8 週
- Formulation
- Not established
- Dose
- KSM-66根萃取物125或300 mg，每日兩次，即250或600 mg/日。
No additional short excerpt is shown for this finding. See the linked source to check the result.
View sourceMain result 3
12 週12週七點睡眠品質2.47對4.3，組間改善p<0.0001；晨間清醒亦有利。四項白天嗜睡量表下降，表格未標示其組間顯著性，不能與主觀夜間睡眠品質混用。
Applicability assessment: 老年成人的安慰劑對照試驗，明確評估睡眠品質。
- Population
- 老年成人
- Intervention
- 印度人參根萃取物
- Comparator
- 相同外觀澱粉安慰劑。
- Outcome
- 睡眠品質
- Follow-up
- 12 週
- Formulation
- Not established
- Dose
- KSM66根萃取物300 mg，每日兩次。
Source excerpt: The observed changes between the Ashwagandha and the placebo group were found statistically significant at week 8 (P 0.001) and at week 12 (P<0.0001).View source
Main result 4
6 週自報睡眠品質改善72%對29%；活動紀錄的SE、TST、SOL及WASO均優於安慰劑。百分比改善不等於恢復正常睡眠的人數。
Applicability assessment: 非恢復性睡眠程度高的健康成人，與安慰劑比較睡眠品質。
- Population
- 非恢復性睡眠程度高的健康成人
- Intervention
- 標準化印度人參萃取物
- Comparator
- 安慰劑。
- Outcome
- 自評睡眠品質
- Follow-up
- 6 週
- Formulation
- Not established
- Dose
- Shoden標準化萃取物120 mg，每日一次；本摘要未明示植物部位。
Source excerpt: A 72% increase in self-reported sleep quality was found for the treatment group, compared with 29% in the placebo group (p < 0.001).View source
Main result 5
8 週摘要報告兩族群睡眠改善，失眠層較突出；SOL、SE、TST與WASO有顯著分析結果。另列多項組內變化，不能全部當作單方對安慰劑效果；健康層晨間清醒未顯著。
Applicability assessment: 同一試驗分層納入健康者及失眠者，兩層均評估睡眠。
- Population
- 健康者及失眠者
- Intervention
- 印度人參根萃取物
- Comparator
- 各族群內安慰劑。
- Outcome
- 睡眠參數及睡眠品質
- Follow-up
- 8 週
- Formulation
- Not established
- Dose
- 單方根萃取物；本摘要未提供劑量或標準化。
Source excerpt: The improvement was found more significant in insomnia subjects than healthy subjects.View source
Main result 6
90天90天PSQI由4.6降至2.5，安慰劑由4.6至4.0；基線調整後組間p<0.0001。屬壓力族群的次要主觀睡眠結果，非失眠治癒證據。
Applicability assessment: 20至55歲健康且中等壓力成人，基線平均PSQI約4.6；孕哺及停經後女性被排除。
- Population
- 健康且有壓力的成人
- Intervention
- 印度人參根萃取物緩釋膠囊
- Comparator
- 相同外觀安慰劑。
- Outcome
- 匹茲堡睡眠品質指數（PSQI）
- Follow-up
- 90天
- Formulation
- Not established
- Dose
- Prolanza緩釋根萃取物300 mg/日，每粒withanolides不少於15 mg。
Source excerpt: Also, at visit 4, the PSQI in the Ashwagandha SR group was significantly lower than in the placebo group (p < .0001).View source
Main result 7
30天主要組別×時間睡眠/壓力MANOVA不顯著；後續以初始睡眠為共變項的分析發現期末睡眠58.4對48.2，p<0.05。後續陽性不應遮蔽原整體檢定無顯著差異。
Applicability assessment: 健康成人大學生，安慰劑對照並評估睡眠。
- Population
- 健康大學生
- Intervention
- 印度人參根全譜萃取物
- Comparator
- 安慰劑。
- Outcome
- 恢復性睡眠及睡眠評估
- Follow-up
- 30天
- Formulation
- Not established
- Dose
- 全譜根萃取物700 mg/日，30天。
No additional short excerpt is shown for this finding. See the linked source to check the result.
View sourceMain result 8
4 週Hooper睡眠項目組別主效應p=0.038，14天組間比較陽性；組別×時間p=0.648，28天組間p=0.087。睡眠改善的結論應限於這些不一致檢定，不能概括28天確有改善。
Applicability assessment: 健康成年女性運動員，單方根萃取物與安慰劑比較感受的睡眠品質。
- Population
- 女性足球員
- Intervention
- 印度人參根萃取物
- Comparator
- 相同膠囊鷹嘴豆粉600 mg/日，維持原訓練背景。
- Outcome
- 自覺睡眠品質
- Follow-up
- 4 週
- Formulation
- Not established
- Dose
- KSM-66根萃取物600 mg/日，5% withanolides，28天。
Source excerpt: The post‐hoc analysis revealed significant improvement in perceived sleep quality in ASH compared to PLA, notably at T1 (14 days) (p = 0.038).View source
Main result 9
12 週28、56及84天PSQI均優於安慰劑；84天變化−3.0對+0.1，41/45對15/45達來源定義的PSQI最小重要改善。壓力生物標記無一致效果不削除睡眠結果，亦不作睡眠替代結果。
Applicability assessment: 輕至中度短期壓力成人，評估PSQI睡眠品質。
- Population
- 有非慢性輕至中度壓力的成人
- Intervention
- Zenroot印度人參製劑
- Comparator
- 相同外觀微晶纖維素安慰劑。
- Outcome
- 匹茲堡睡眠品質指數（PSQI）總分
- Follow-up
- 12 週
- Formulation
- Not established
- Dose
- Zenroot印度人參粉125 mg/日，1.5%總withanolides，84天；節錄未明確核實植物部位。
No additional short excerpt is shown for this finding. See the linked source to check the result.
View sourceMain result 10
60天單方臂60天PSQI調整組間差−1.62（95% CI −2.40至−0.84）、RSQ-W差+8.93（4.71至13.15）。30天兩項總分未顯著；60天睡眠時長、效率、幹擾、用藥及晨間清醒未顯著，主觀品質、潛伏期與日間功能有利。多草藥臂結果不能歸給單方。
Applicability assessment: 高度壓力成人，研究包含可分離的單方印度人參根製劑臂及睡眠結果。
- Population
- 高度壓力成人
- Intervention
- VL-G-E12印度人參根製劑
- Comparator
- 共同橄欖油安慰劑，雙模擬給藥；僅VL-G-E12單方臂用於本題療效。
- Outcome
- 睡眠時長與睡眠干擾分數
- Follow-up
- 60天
- Formulation
- Not established
- Dose
- VL-G-E12每粒175 mg根萃取物配方，每日兩粒；來源稱每份withanolides不少於2.5 mg，服用60天。
No additional short excerpt is shown for this finding. See the linked source to check the result.
View sourceMain result 11
12 週12週PSQI總分變化組間差−2.71（95% CI −4.36至−1.07），主觀品質、幹擾及日間功能有利；睡眠潛伏期、效率及用藥未顯著。正文稱睡眠時長增加，但表中小時變化−1.89對−0.22，方向矛盾，不能確認時長改善。
Applicability assessment: 第二孕期成人女性，在共同造血療法背景下比較根萃取物加用與不加用，評估睡眠。
- Population
- 第二孕期孕婦
- Intervention
- 印度人參根萃取物加用於標準造血療法
- Comparator
- 兩組相同Autrin造血補充療法；對照不加根萃取物。
- Outcome
- 睡眠潛伏期、睡眠效率與助眠藥使用
- Follow-up
- 12 週
- Formulation
- Not established
- Dose
- KSM-66標準化根萃取物300 mg，每日兩次；測得總withanolides 5.33%，加用於造血補充療法。
Source excerpt: Although changes in sleep latency, sleep efficiency, and use of sleep medication favored ARE, these did not reach statistical significance.View source
Main result 12
60天兩劑量從第7天起PSQI優於安慰劑；60天總分5.54、4.52及7.59。300 mg數值改善較大，但來源未證明睡眠劑量間差異顯著。
Applicability assessment: 健康且有壓力的成人，單方緩釋根萃取物與安慰劑比較PSQI。
- Population
- 健康且有壓力的成人
- Intervention
- AshwaSR印度人參根萃取物緩釋膠囊
- Comparator
- 相同外觀安慰劑，共同三臂設計。
- Outcome
- PSQI總分
- Follow-up
- 60天
- Formulation
- Not established
- Dose
- AshwaSR緩釋根萃取物150或300 mg/日，總withanolides不少於4%，60天。
Source excerpt: Compared to group C, PSQI global score significantly reduced as early as day 7 in group A and group B (Table 2).View source
Main result 13
8 週純單方對安慰劑8週SOL變化−14.6對−7.2分鐘，PSQI −2.9對−1.4；表註支持SOL、TST、WASO、SE及主觀品質的指定比較。TIB僅4週變化有顯著對比，8週未列；晨間清醒未證明單方優勢。合用較佳不能歸給純單方。
Applicability assessment: 有睡眠困擾的成人，研究中有可分離的印度人參根萃取物單用對安慰劑比較。
- Population
- 有睡眠困擾的成人
- Intervention
- 印度人參根萃取物單用
- Comparator
- 純根萃取物對雙安慰劑；褪黑激素單用與合用結果分開。
- Outcome
- 入睡潛伏期、總睡眠時間、入睡後清醒時間及臥床時間
- Follow-up
- 8 週
- Formulation
- Not established
- Dose
- KSM-66根萃取物300 mg，每日兩次，withanolides >5%；純單方臂另用褪黑激素安慰劑。
No additional short excerpt is shown for this finding. See the linked source to check the result.
View sourceMain result 14
12 週主要PSQI結果變化−5.2對−0.8，p<0.001，支持此停經後族群短期睡眠品質改善；更年期症狀改善是另一結果。
Applicability assessment: 停經後女性的安慰劑對照試驗，以PSQI評估睡眠品質。
- Population
- 停經後女性
- Intervention
- 印度人參根萃取物
- Comparator
- 安慰劑。
- Outcome
- 睡眠品質
- Follow-up
- 12 週
- Formulation
- Not established
- Dose
- 根萃取物600 mg/日；摘要未提供標準化。
No additional short excerpt is shown for this finding. See the linked source to check the result.
View sourceAdditional finding 15
三個月及六個月評估比較瑜伽、阿育吠陀草藥製劑及等候名單對老年人自評睡眠的影響。
Applicability assessment: 老年人的睡眠結果相關，但草藥製劑成分不明。
- Population
- 安養機構老年住民
- Intervention
- 阿育吠陀草藥製劑，成分未明
- Comparator
- 等候名單對照
- Outcome
- 自評睡眠
- Follow-up
- 三個月及六個月評估
- Formulation
- Not established
- Dose
- Not established
Source excerpt: the present study was designed to compare the effects of Yoga and Ayurveda on the self rated sleep in a geriatric population.View source
Safety finding 16
10 週研究期未報不良事件；兩人因活動紀錄不遵從退出。
Applicability assessment: 同一失眠與焦慮成人試驗的不良事件資料。
- Population
- 失眠及焦慮患者
- Intervention
- 口服印度人參根萃取物膠囊
- Comparator
- 相同外觀澱粉安慰劑；兩組均以牛奶或水服用。
- Outcome
- 不良事件
- Follow-up
- 10 週
- Formulation
- Not established
- Dose
- KSM-66根萃取物300 mg，每日兩次；來源稱withanolides >5%。
No additional short excerpt is shown for this finding. See the linked source to check the result.
View sourceSafety finding 17
8 週58人有安全資料，未報不良事件；250 mg及安慰劑各一人失訪。
Applicability assessment: 同一壓力成人試驗的不良事件資料。
- Population
- 有壓力困擾的健康成人
- Intervention
- 印度人參根萃取物
- Comparator
- 相同外觀澱粉安慰劑，共同三臂設計。
- Outcome
- 不良事件資料
- Follow-up
- 8 週
- Formulation
- Not established
- Dose
- KSM-66根萃取物125或300 mg，每日兩次，即250或600 mg/日。
Source excerpt: Data for adverse events were available only for 58 participants as two subjects were lost in follow-up.View source
Safety finding 18
12 週未報不良事件或因不良事件退出；11人因不遵從退出。
Applicability assessment: 同一老年成人試驗的不良事件資料。
- Population
- 老年成人
- Intervention
- 印度人參根萃取物
- Comparator
- 相同外觀澱粉安慰劑。
- Outcome
- 不良事件
- Follow-up
- 12 週
- Formulation
- Not established
- Dose
- KSM66根萃取物300 mg，每日兩次。
No additional short excerpt is shown for this finding. See the linked source to check the result.
View sourceSafety finding 19
6 週未報治療相關不良事件，亦無因不良事件退出；不能推為所有不良事件皆零。
Applicability assessment: 同一非恢復性睡眠成人試驗的治療相關不良事件資料。
- Population
- 非恢復性睡眠程度高的健康成人
- Intervention
- 標準化印度人參萃取物
- Comparator
- 安慰劑。
- Outcome
- 治療相關不良事件
- Follow-up
- 6 週
- Formulation
- Not established
- Dose
- Shoden標準化萃取物120 mg，每日一次；本摘要未明示植物部位。
No additional short excerpt is shown for this finding. See the linked source to check the result.
View sourceSafety finding 20
8 週僅稱所有參與者耐受良好，未提供具體不良事件或退出數。
Applicability assessment: 同一健康與失眠分層試驗的耐受性資料。
- Population
- 健康者及失眠者
- Intervention
- 印度人參根萃取物
- Comparator
- 各族群內安慰劑。
- Outcome
- 耐受性
- Follow-up
- 8 週
- Formulation
- Not established
- Dose
- 單方根萃取物；本摘要未提供劑量或標準化。
No additional short excerpt is shown for this finding. See the linked source to check the result.
View sourceAdditional finding 21
系統性回顧及統合分析納入成人睡眠相關安慰劑對照試驗。
Applicability assessment: 彙整成人印度人參與安慰劑睡眠試驗，屬既有試驗的綜述。
- Population
- 成人
- Intervention
- 印度人參萃取物
- Comparator
- 安慰劑
- Outcome
- 睡眠量與睡眠品質
- Follow-up
- Not established
- Formulation
- Not established
- Dose
- Not established
Source excerpt: Randomized controlled trials that examined the effect of Ashwagandha extract versus placebo on sleep in human participants 18 years old and above were considered.View source
Safety finding 22
90天90天未觀察不良事件，血球、肝腎安全指標無異常；5人疫情封鎖期間自願撤回。
Applicability assessment: 20至55歲健康且中等壓力成人，基線平均PSQI約4.6；孕哺及停經後女性被排除。
- Population
- 健康且有壓力的成人
- Intervention
- 印度人參根萃取物緩釋膠囊
- Comparator
- 相同外觀安慰劑。
- Outcome
- 不良事件
- Follow-up
- 90天
- Formulation
- Not established
- Dose
- Prolanza緩釋根萃取物300 mg/日，每粒withanolides不少於15 mg。
No additional short excerpt is shown for this finding. See the linked source to check the result.
View sourceAdditional finding 23
30天研究比較印度人參根粉加鼻滴療法與根粉單用於老年原發性失眠。
Applicability assessment: 老年失眠患者有睡眠結果，但兩組分別使用單方根粉與加用鼻滴的複合療法。
- Population
- 老年原發性失眠患者
- Intervention
- 口服印度人參根粉加鼻滴療法
- Comparator
- 印度人參根粉單用
- Outcome
- 匹茲堡睡眠品質指數所評估的失眠症狀
- Follow-up
- 30天
- Formulation
- Not established
- Dose
- Not established
Source excerpt: To determine the combined efficacy of oral administration of Ashwagandha root powder along with Brimhana Nasya with Ksheera Bala Taila in primary insomnia in geriatric.View source
Additional finding 24
30天質性分析探討大學生使用印度人參後的睡眠等主觀經驗。
Applicability assessment: 大學生的同一安慰劑對照試驗之質性報告，涉及睡眠感受。
- Population
- 成人大學生
- Intervention
- 印度人參根全譜萃取物
- Comparator
- 甘油安慰劑膠囊
- Outcome
- 睡眠經驗與睡眠品質感受
- Follow-up
- 30天
- Formulation
- Not established
- Dose
- Not established
No additional short excerpt is shown for this finding. See the linked source to check the result.
View sourceAdditional finding 25
8週評估研究評估口服、外用及合併產品對睡眠等結果的影響。
Applicability assessment: 健康女性有睡眠結果，但口服及外用品含多種成分。
- Population
- 自認敏感肌膚的健康女性
- Intervention
- 含多種天然成分的口服與外用產品
- Comparator
- 外用組或口服與外用合併組
- Outcome
- 匹茲堡睡眠品質指數（PSQI）
- Follow-up
- 8週評估
- Formulation
- Not established
- Dose
- Not established
No additional short excerpt is shown for this finding. See the linked source to check the result.
View sourceAdditional finding 26
90天研究在憂鬱與焦慮患者中評估印度人參根萃取物加胡椒鹼，並量測睡眠品質。
Applicability assessment: 成人的安慰劑對照睡眠評估，但製劑合用胡椒鹼。
- Population
- 輕至中度憂鬱及焦慮者
- Intervention
- 印度人參根萃取物加胡椒鹼
- Comparator
- 安慰劑
- Outcome
- 格羅寧根睡眠品質量表
- Follow-up
- 90天
- Formulation
- Not established
- Dose
- Not established
No additional short excerpt is shown for this finding. See the linked source to check the result.
View sourceAdditional finding 27
系統性回顧及統合分析搜尋焦慮或失眠患者的安慰劑對照隨機試驗。
Applicability assessment: 彙整焦慮或失眠患者的印度人參安慰劑對照試驗，與原始試驗可能重疊。
- Population
- 焦慮及／或失眠患者
- Intervention
- 印度人參
- Comparator
- 安慰劑
- Outcome
- 失眠相關睡眠測量結果
- Follow-up
- Not established
- Formulation
- Not established
- Dose
- Not established
No additional short excerpt is shown for this finding. See the linked source to check the result.
View sourceAdditional finding 28
90天四臂研究比較添加印度人參等成分的牛奶與未添加的牛奶，評估主觀睡眠。
Applicability assessment: 有睡眠問題的成人，但研究奶飲品包含其他活性成分。
- Population
- 有睡眠問題的健康成人
- Intervention
- 添加印度人參萃取物及其他成分的牛奶
- Comparator
- 未添加萃取物的脫脂牛奶
- Outcome
- 主觀睡眠品質
- Follow-up
- 90天
- Formulation
- Not established
- Dose
- Not established
No additional short excerpt is shown for this finding. See the linked source to check the result.
View sourceSafety finding 29
4 週兩組未發生不良事件；兩人因離開球隊於分析前退出。
Applicability assessment: 同一女性足球員試驗的不良事件資料。
- Population
- 女性足球員
- Intervention
- 印度人參根萃取物
- Comparator
- 相同膠囊鷹嘴豆粉600 mg/日，維持原訓練背景。
- Outcome
- 不良事件
- Follow-up
- 4 週
- Formulation
- Not established
- Dose
- KSM-66根萃取物600 mg/日，5% withanolides，28天。
No additional short excerpt is shown for this finding. See the linked source to check the result.
View sourceSafety finding 30
12 週至少一項事件33.3%對20%；發熱6對4人、胃炎3對1人，各組一人中度事件，其餘輕度。研究者判定全部無關產品、均已消退，無因事件退出；不是零事件。
Applicability assessment: 同一短期壓力成人試驗的分組不良事件資料。
- Population
- 有非慢性輕至中度壓力的成人
- Intervention
- Zenroot印度人參製劑
- Comparator
- 相同外觀微晶纖維素安慰劑。
- Outcome
- 至少一項不良事件
- Follow-up
- 12 週
- Formulation
- Not established
- Dose
- Zenroot印度人參粉125 mg/日，1.5%總withanolides，84天；節錄未明確核實植物部位。
No additional short excerpt is shown for this finding. See the linked source to check the result.
View sourceSafety finding 31
60天全試驗11個事件：頭痛5、咳嗽及感冒各2、手燒傷與刀割各1；皆輕度、研究者判無關且消退，無嚴重事件或因此退出。未提供分臂事件數，不能全部歸於單方。
Applicability assessment: 同一三臂壓力成人試驗的不良事件資料，來源未提供單方臂分配。
- Population
- 高度壓力成人
- Intervention
- 含印度人參根的試驗製劑；事件未分臂
- Comparator
- 共同橄欖油安慰劑，雙模擬給藥；僅VL-G-E12單方臂用於本題療效。
- Outcome
- 不良事件
- Follow-up
- 60天
- Formulation
- Not established
- Dose
- VL-G-E12每粒175 mg根萃取物配方，每日兩粒；來源稱每份withanolides不少於2.5 mg，服用60天。
No additional short excerpt is shown for this finding. See the linked source to check the result.
View sourceAdditional finding 32
8週三臂試驗比較天門冬屬草藥、其與印度人參根萃取物合用及安慰劑，並量測PSQI。
Applicability assessment: 女性試驗量測PSQI，但含印度人參的臂同時使用天門冬屬草藥。
- Population
- 女性
- Intervention
- 天門冬屬草藥與印度人參根萃取物合用
- Comparator
- 安慰劑或單用天門冬屬草藥
- Outcome
- 匹茲堡睡眠品質指數（PSQI）
- Follow-up
- 8週
- Formulation
- Not established
- Dose
- Not established
Source excerpt: Participants were randomly assigned to receive either SHT, Shatavari with Ashwagandha root extracts (SHT-ARE), or a placebo (PL).View source
Safety finding 33
12 週12週未報母體不良或嚴重事件，肝腎甲狀腺指標無明顯不利變化；胎兒健康未評估，無法判定完整母胎安全。
Applicability assessment: 同一第二孕期加用試驗的母體不良事件資料。
- Population
- 第二孕期孕婦
- Intervention
- 印度人參根萃取物加用於標準造血療法
- Comparator
- 兩組相同Autrin造血補充療法；對照不加根萃取物。
- Outcome
- 不良事件
- Follow-up
- 12 週
- Formulation
- Not established
- Dose
- KSM-66標準化根萃取物300 mg，每日兩次；測得總withanolides 5.33%，加用於造血補充療法。
No additional short excerpt is shown for this finding. See the linked source to check the result.
View sourceSafety finding 34
60天150 mg、300 mg及安慰劑分別3、1及1人有事件，包括發熱、肌痛、嘔吐、搔癢與逆流；皆輕度短暫4至5天、研究者判無關並完全消退。
Applicability assessment: 同一健康壓力成人三臂試驗的分組不良事件資料。
- Population
- 健康且有壓力的成人
- Intervention
- AshwaSR印度人參根萃取物緩釋膠囊
- Comparator
- 相同外觀安慰劑，共同三臂設計。
- Outcome
- 不良事件
- Follow-up
- 60天
- Formulation
- Not established
- Dose
- AshwaSR緩釋根萃取物150或300 mg/日，總withanolides不少於4%，60天。
No additional short excerpt is shown for this finding. See the linked source to check the result.
View sourceSafety finding 35
8 週事件發生率純單方6%、安慰劑6%、褪黑激素10%、合用12%；常見噁心、輕微頭痛、腹痛，少見嗜睡，無嚴重事件。來源未提供各事件分臂人數。
Applicability assessment: 同一成人睡眠困擾試驗的分組不良事件資料。
- Population
- 有睡眠困擾的成人
- Intervention
- 印度人參根萃取物單用
- Comparator
- 純根萃取物對雙安慰劑；褪黑激素單用與合用結果分開。
- Outcome
- 不良事件發生率
- Follow-up
- 8 週
- Formulation
- Not established
- Dose
- KSM-66根萃取物300 mg，每日兩次，withanolides >5%；純單方臂另用褪黑激素安慰劑。
Source excerpt: Overall incidence of adverse events was low and comparable across groups: ARE 6%, MLT 10%, ARE–MLT 12%, PLB 6%.View source
Additional finding 36
45天病例報告描述多草藥足浴後以失眠嚴重度指數追蹤睡眠。
Applicability assessment: 慢性失眠病例有睡眠結果，但介入為多草藥足浴且無同期對照。
- Population
- 一名慢性失眠成年男性
- Intervention
- 含印度人參等草藥的足浴
- Comparator
- 無同期對照
- Outcome
- 失眠嚴重度指數（ISI）
- Follow-up
- 45天
- Formulation
- Not established
- Dose
- Not established
Source excerpt: Clinical improvement was assessed using the Insomnia Severity Index (ISI).View source
Safety finding 37
12 週無嚴重不良事件且耐受良好；未提供所有事件數或3名未完成者的退出原因。
Applicability assessment: 同一停經後女性試驗的嚴重不良事件與耐受性資料。
- Population
- 停經後女性
- Intervention
- 印度人參根萃取物
- Comparator
- 安慰劑。
- Outcome
- 嚴重不良事件與耐受性
- Follow-up
- 12 週
- Formulation
- Not established
- Dose
- 根萃取物600 mg/日；摘要未提供標準化。
Source excerpt: The intervention was well tolerated with no serious adverse events.View source
Additional finding 38
補充兩週四組研究比較早晨及晚間多成分補充品與安慰劑，量測主觀及客觀睡眠。
Applicability assessment: 健康成人有睡眠結果，但早晨製劑同時含印度人參與紅景天。
- Population
- 健康且有身體活動的成人
- Intervention
- 早晨印度人參與紅景天合用補充品
- Comparator
- 早晚均用安慰劑的組別
- Outcome
- 主觀及客觀睡眠品質
- Follow-up
- 補充兩週
- Formulation
- Not established
- Dose
- Not established
Source excerpt: this study evaluated the impact of morning adaptogens, evening sleep-focused supplements, and their combination on stress, mood, and subjective and objective sleep quality.View source
Sources consulted
- Influence of Yoga and Ayurveda on self-rated sleep in a geriatric population. Context source; not counted as an included human-result report Abstract only · 2026-10-06T06:01:15.138819Z
- Efficacy and Safety of Ashwagandha (Withania somnifera) Root Extract in Insomnia and Anxiety: A Double-blind, Randomized, Placebo-controlled Study. Full-text excerpt · 2026-10-06T06:01:15.138819Z
- Adaptogenic and Anxiolytic Effects of Ashwagandha Root Extract in Healthy Adults: A Double-blind, Randomized, Placebo-controlled Clinical Study. Full-text excerpt · 2026-10-06T06:01:15.138819Z
- Efficacy and Tolerability of Ashwagandha Root Extract in the Elderly for Improvement of General Well-being and Sleep: A Prospective, Randomized, Double-blind, Placebo-controlled Study. Full-text excerpt · 2026-10-06T06:01:15.138819Z
- A randomized, double blind, placebo controlled study to evaluate the effects of ashwagandha (Withania somnifera) extract on sleep quality in healthy adults. Abstract only · 2026-10-06T06:01:15.138819Z
- Clinical evaluation of the pharmacological impact of ashwagandha root extract on sleep in healthy volunteers and insomnia patients: A double-blind, randomized, parallel-group, placebo-controlled study. Abstract only · 2026-10-06T06:01:15.138819Z
- Effect of Ashwagandha (Withania somnifera) extract on sleep: A systematic review and meta-analysis. Context source; not counted as an included human-result report Full-text excerpt · 2026-10-06T06:01:15.138819Z
- Efficacy and Safety of Ashwagandha Root Extract on Cognitive Functions in Healthy, Stressed Adults: A Randomized, Double-Blind, Placebo-Controlled Study. Full-text excerpt · 2026-10-06T06:01:15.138819Z
- Efficacy of Brimhana Nasya and Ashwagandha (Withania somnifera (L.) Dunal) root powder in primary insomnia in elderly male: A randomized open-label clinical study. Context source; not counted as an included human-result report Abstract only · 2026-10-06T06:01:15.138819Z
- The Perceived Impact of Ashwagandha on Stress, Sleep Quality, Energy, and Mental Clarity for College Students: Qualitative Analysis of a Double-Blind Randomized Control Trial. Context source; not counted as an included human-result report Abstract only · 2026-10-06T06:01:15.138819Z
- The Impact of Ashwagandha on Stress, Sleep Quality, and Food Cravings in College Students: Quantitative Analysis of a Double-Blind Randomized Control Trial. Abstract only · 2026-10-06T06:01:15.138819Z
- Combining Topical and Oral Botanicals for Skin Redness, Pigmentation, Sleep, and Mood: A Randomized Controlled Study. Context source; not counted as an included human-result report Abstract only · 2026-10-06T06:01:15.138819Z
- A Standardized Withania somnifera (Linn.) Root Extract with Piperine Alleviates the Symptoms of Anxiety and Depression by Increasing Serotonin Levels: A Double-Blind, Randomized, Placebo-Controlled Study. Context source; not counted as an included human-result report Abstract only · 2026-10-06T06:01:15.138819Z
- Safety and efficacy of Withania somnifera for anxiety and insomnia: Systematic review and meta-analysis. Context source; not counted as an included human-result report Abstract only · 2026-10-06T06:01:15.138819Z
- Effectiveness of Enriched Milk with Ashwagandha Extract and Tryptophan for Improving Subjective Sleep Quality in Adults with Sleep Problems: A Randomized Double-Blind Controlled Trial. Context source; not counted as an included human-result report Full-text excerpt · 2026-10-06T06:01:15.138819Z
- Effects of Root Extract of Ashwagandha (Withania somnifera) on Perception of Recovery and Muscle Strength in Female Athletes. Full-text excerpt · 2026-10-06T06:01:15.138819Z
- A New Ashwagandha Formulation (Zenroot™) Alleviates Stress and Anxiety Symptoms While Improving Mood and Sleep Quality: A Randomized, Double-Blind, Placebo-Controlled Clinical Study. Full-text excerpt · 2026-10-06T06:01:15.138819Z
- Effects of multi-herb and ashwagandha root formulas on stress modulation: a randomized, double-blind, placebo-controlled clinical study. Full-text excerpt · 2026-10-06T06:01:15.138819Z
- Effects of Shatavari (Asparagus racemosus) Root Extract on Sexual Wellness in Women: Findings from a Prospective, Randomized, Double-Blind, Three-Arm, Parallel-Group, Placebo-Controlled Study. Context source; not counted as an included human-result report Abstract only · 2026-10-06T06:01:15.138819Z
- Efficacy and safety of Ashwagandha (Withania somnifera) root extract in pregnant women: a prospective, randomized, comparative, open-label, 12-week study. Full-text excerpt · 2026-10-06T06:01:15.138819Z
- Efficacy and safety of Ashwagandha root extract sustained-release (AshwaSR) capsules in healthy adult, stressed subjects: A randomized, double-blind, placebo-controlled, parallel-group, 3-arm clinical trial. Full-text excerpt · 2026-10-06T06:01:15.138819Z
- Comparative Evaluation of Ashwagandha (Withania somnifera) Root Extract and Melatonin for Improving Sleep Quality in Adults: A Prospective, Randomized, Double-Blind, Placebo-Controlled Study. Full-text excerpt · 2026-10-06T06:01:15.138819Z
- Therapeutic evaluation of Pāshoya (herbal footbath) in the management of chronic insomnia: A case report. Context source; not counted as an included human-result report Abstract only · 2026-10-06T06:01:15.138819Z
- Effects of Withania somnifera root extract on sleep quality, body composition, and menopausal symptoms in postmenopausal women: a randomized, double-blind, placebo-controlled trial. Abstract only · 2026-10-06T06:01:15.138819Z
- Modulating stress and sleep through a multi-compound dietary supplement: a randomized, double-blind, placebo-controlled trial. Context source; not counted as an included human-result report Abstract only · 2026-10-06T06:01:15.138819Z
Reading and assessment notes
This is an AI preliminary assessment, not expert review or formal GRADE. Read the method and common limitations.
Absence of reported harms does not establish safety. This summary does not provide individual treatment or dosing advice.
Data and assessment record
Search coverage for this case
對有睡眠困擾或研究明確報告睡眠結果的成人，口服單一印度人參（Withania somnifera）製劑相較安慰劑或其他條件相同的同期對照，是否改善睡眠品質、睡眠症狀及睡眠測量結果，並有哪些不良反應？健康者、壓力困擾與確診失眠者及不同製劑分層呈現。
Searched：2026-10-06T06:01:15.138819Z · Databases：PubMed
121 records identified; 121 screened; 14 reports included, representing at least 9 study populations. Some relationships remain unresolved.
Some included reports were assessed without full text.
- 部分候選文獻未取得全文，完整偏倚風險與次要結果評讀受限。
- 系統檢索限於 PubMed；未涵蓋所有資料庫與完整引文追查。
Processing record
Evidence summary available
Sources through：2026-10-06 · Generated：2026-10-06T07:19:08.804305+00:00
Retrieved 121 records · Screened 121 · Included 14 reports · Omitted 107
Run：rating-candidate-final-v1
codex_cli / gpt-6.1-sol / problem-search-source-bound-l2+l11-v1
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