CTRI/2022/10/046550SuspendedPhase 1/2
A Randomized, Double Blind, Placebo Controlled Study to Evaluate the Effect of Ashwagandha (Withania somnifera)Extract in the management of Insomnia
Arjuna Natural Private Limited,1 site in 1 country50 target enrollmentStarted: October 19, 2022Last updated:
Trial Snapshot
- Phase
- Phase 1/2
- Status
- Suspended
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Mean change in Sleep questionnaires
Study Overview
Brief Summary
This is a randomized, double-blind, placebo-controlled study in participants with disturbed sleep. Qualified participants will be randomized into two groups in 1:1 ratio to test product or placebo and advised to take 500 mg of capsule for 30 days. The participants were assessed by sleep questionnaires and sleep diary.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Participant, Investigator and Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 25.00 Year(s) to 64.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •A primary complaint of sleep-onset insomnia for at least 6 months defined as a sleep-onset latency of at least 1 hour over 3 nights a week as verified by pre-screening sleep diaries
- •At least 1 negative daytime complaint (eg, fatigue, impaired mood, or performance) attributed to insomnia
- •Pittsburgh Sleep Quality Index (PSQI) Score > 5
- •Insomnia Severity Index (ISI) Score 15 – 21
- •Athens Insomnia scale score >10
- •STOP-BANG score < 3
- •Sleep Onset Latency >31 minutes a night, as confirmed by the pre-screening sleep diary 8.
Exclusion Criteria
- •Current use of prescription or over-the-counter sleep medications or unwillingness or inability to discontinue use of these medications at least 4 weeks before beginning the study
- •Medical problems that would be a direct cause of insomnia
- •Current treatment for depression, alcohol or substance abuse, or psychosis
- •Previous diagnosis of sleep apnea or periodic limb movements or prior CBT for insomnia
- •Initiation of psychotherapy in the previous 6 months
- •Women of childbearing age who were pregnant, breastfeeding, or not practicing contraception
- •Shift work
- •Epworth Sleepiness Scale (ESS) a score ≥ 9
- •Beck depression inventory-II(BDI-II) > 13
- •Any condition, including laboratory abnormalities, that in the opinion of investigator places the volunteer at an unacceptable risk or deems the volunteer not suitable for participation in the study.
Outcomes
Primary Outcomes
Mean change in Sleep questionnaires
Time Frame: Baseline, Day 15 and Day 30
Secondary Outcomes
- Assessment of Sleep diary(Baseline to Day 30)
Investigators
Study Sites (1)
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