Clinical TrialID 7782
Prospective, Multi Centric, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of KSM-66 Ashwagandha (Withania Somnifera) in Adults Experiencing High Stress and/or Anxiety
NCT05684991
Anxiety|Stress
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Record Fields
Scalar fields from the final clinical_trial record.
- Clinical Trial Id
- 7782
- Evidence Id
- 7782
- Core Evidence Id
- 7782
- Source Clinical Trial Id
- 7775
- Herb2 Clinical Trial Id
- HBCT007775
- Nct Id
- NCT05684991
- Title
- Prospective, Multi Centric, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of KSM-66 Ashwagandha (Withania Somnifera) in Adults Experiencing High Stress and/or Anxiety
- Status
- Active_Not_Recruiting
- Phase
- Study Result
- No
- Study Condition
- Anxiety|Stress
- Study Type
- Interventional
- Study Design
- Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
- Intervention
- DIETARY_SUPPLEMENT: KMS-66 Ashwagandha 300mg|DIETARY_SUPPLEMENT: placebo capsule
- Intervention Allocation
- Randomized
- Intervention Model
- Parallel
- Intervention Mask
- Quadruple
- Intervention Purpose
- Treatment
- Gender
- All
- Age
- Adult, Older_Adult
- Enrollment
- 50
- Outcome Measure
- Hamilton Anxiety Rating Scale (HAM-A), The scale consists of 14 items, each defined by a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety), 8 weeks
- Sponsor Collaborator
- SF Research Institute, Inc.|Ixoreal Biomed Inc.
- Funded By
- NETWORK
- Location
- SF Research Institute, Inc., San Francisco, California, 94127, United States
- Other Id
- KSM-66/PMS/2018/09
- Start Date
- 2022-09-19
- Primary Completion Date
- 2023-01-10
- Completion Date
- 2023-01-31
- First Posted
- 2023-01-13
- Results First Posted
- Last Update Posted
- 2023-01-13
- Study Document
- Study Url
- https://clinicaltrials.gov/study/NCT05684991
- Title Cn
- Title En
- Prospective, Multi Centric, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of KSM-66 Ashwagandha (Withania Somnifera) in Adults Experiencing High Stress and/or Anxiety
- Bilingual Status
- semi_complete