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临床试验/CTRI/2023/03/050974
CTRI/2023/03/050974已完成1 期

A Randomized, Double Blind, Placebo Controlled Pilot Study to Evaluate the Effect of Ashwagandha (Withania somnifera) Extract in improving memory in adults with mild cognitive impairment

Arjuna Natural Private Limited,0 个研究点目标入组 40 人开始时间: 待定最近更新:

试验速览

阶段
1 期
状态
已完成
入组人数
40

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

入选标准

  • 1. Age between 25 to 65 years
  • 2. Participants with mild, subjective symptoms of memory impairment
  • 3. Participants with no impairment in Social and Occupational Functioning
  • 4. Instrumental Activities of Daily Life (IADL) score > 6
  • 5. Montreal Cognitive Assessment (MoCA) Score 18-25
  • 6. Clinical Dementia Rating (CDR) Global score < 0.5
  • 7. Mini-Mental State Examination (MMSE) score 20-23
  • 8. Vitamin B12 (Serum) 200-900pg/mL

排除标准

  • 1. Known neuropsychiatric conditions including depression
  • 2. Persistent endocrine disorders
  • 3. Uncontrolled hypertension
  • 4. Diabetes mellitus
  • 5. Drug dependence or addiction
  • 6. Use of alcohol
  • 7. Psychotropic drugs or drugs or alternative medicines for memory enhancement, or any severe comorbid medical condition.
  • 8. Pregnant or lactating women and
  • 9. Subjects with known hypersensitivity to ashwagandha
  • 10. Other than ashwagandha in the treatment group, the use of nootropic agents or anticholinesterase drugs will be prohibited during the study.
  • 11. History of significant brain disorders (e.g., stroke or epilepsy);
  • 12. Use of any type of dementia-delaying medication;
  • 13. Head trauma with post-traumatic loss of consciousness for at least 30 min during the lifespan
  • 14. Brain damaged patients (brain tumour; penetrating head injury; closed head injury; cerebral vascular accident; cerebral abscess; cerebral atrophy; subdural hematoma; temporal lobectomy for epilepsy; dementia paralytica; congenital anomaly of brain)

研究者

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