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

Phase 1

Suspended

• Registration Number: CTRI/2022/10/046550
• Lead Sponsor: Arjuna Natural Private Limited,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 16 October 2023

Recruitment & Eligibility

• Status: Suspended
• Sex: Not specified
• Target Recruitment: 0

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 < 3

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified