To study the effect of Ashwagandha extract in people with disturbed sleep

A Randomized, Double Blind, Placebo Controlled Study to Evaluate the Effect of Ashwagandha (Withania somnifera) Extract in the management of Insomnia

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/10/046550

Enrollment

Registered

2022-10-17

Start date

Unknown

Completion date

Unknown

Last updated

2023-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Ashwagandha extract: 500 mg once daily for 30 days Control Intervention1: Placebo: 500 mg once daily for 30 days

Eligibility

Inclusion criteria

Inclusion criteria: 1. 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 2. At least 1 negative daytime complaint (eg, fatigue, impaired mood, or performance) attributed to insomnia 3. Pittsburgh Sleep Quality Index (PSQI) Score > 5 4. Insomnia Severity Index (ISI) Score 15 – 21 5. Athens Insomnia scale score >10 6. STOP-BANG score 7. Sleep Onset Latency >31 minutes a night, as confirmed by the pre-screening sleep diary 8. Willing to provide written informed consent

Exclusion criteria

Exclusion criteria: 1. 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 2. Medical problems that would be a direct cause of insomnia 3. Current treatment for depression, alcohol or substance abuse, or psychosis 4. Previous diagnosis of sleep apnea or periodic limb movements or prior CBT for insomnia 5. Initiation of psychotherapy in the previous 6 months 6. Women of childbearing age who were pregnant, breastfeeding, or not practicing contraception 7. Shift work 8. Epworth Sleepiness Scale (ESS) a score = 9 9. Beck depression inventory-II(BDI-II) > 13 10. 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.

Design outcomes

Primary

Measure	Time frame
Mean change in Sleep questionnairesTimepoint: Baseline, Day 15 and Day 30	—

Secondary

Measure	Time frame
Assessment of Sleep diaryTimepoint: Baseline to Day 30	—

Countries

India

Contacts

Public ContactDr Giby Abraham

Arjuna Natural Private Limited

drbinu@arjunanatural.com09447818432

Outcome results