Role of Ashwagandha and Melatonin on patients with Insomnia

Not Applicable

• Conditions: Health Condition 1: F510- Insomnia not due to a substance orknown physiological condition

• Registration Number: CTRI/2022/10/046179
• Lead Sponsor: Ixoreal Biomed Private Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 6 March 2023

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Subjects of either gender, aged 18 to 50 years

2. Participants having insomnia characterized by the following criteria at the time of randomization:

a) Diagnosis of insomnia based on DSM-IV criteria

b) More than 30 minutes to fall asleep and subjective total sleep time of <=6.5 hours per night (for at least 3 nights per week); and daytime complaints associated with disturbed

sleep

3. Habitual bedtime between 8.30 pm to midnight

4. Body Mass Index between 16.5 to 30 kg/sq.m.

5. Subjects able to understand the sleep diary and are willing to fill the sleep-log and follow

other procedures required by the study protocol

6. Subjects who sign the informed written consent

Exclusion Criteria

1. Pregnant or breast-feeding women or women with positive urinary pregnancy test at screening.

2. Known clinically significant endocrine, metabolic, hepatic, renal, cardiovascular,

gastrointestinal, respiratory, haematological or neurological illnesses.

3. Presence of any current psychiatric disorders that are judged by investigator as potentially

causing or contributing to insomnia.

4. Subjects who suffer from sleep disorder other than primary insomnia including restless leg

syndrome and sleep apnea.

5. Substance dependence/ abuse in the past one year or with alcohol abuse are ineligible.

6. Those using tobacco products during night awakenings.

7. History of seizures or significant head trauma.

8. Subjects who travelled across four or more time zones or worked on night or rotating shifts in previous 7 days before study initiation or who plan to do the same during the study period.

9. Currently taking any medication on a regular basis (except for antihypertensives, antidiabetics, lipid lowering agents and drugs for primary cardiovascular prophylaxis).

10. Any other investigational drug was used within three months prior the entry in this study.

11. Those who cannot be relied upon to comply with the test procedures or are unwilling to give informed consent.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sleep Onset latency (SOL)- ActigraphyTimepoint: Baseline, 1 Week, 2 Weeks, 4 Weeks

Secondary Outcome Measures

Name	Time	Method
Total Time In Bed (TTIB)- ActigraphyTimepoint: Baseline, 1 Week, 2 Weeks, 4 Weeks;Wake After Sleep Onset (WASO)- ActigraphyTimepoint: Baseline, 1 Week, 2 Weeks, 4 Weeks;Change from baseline in day-time napsTimepoint: 1 Week, 2 Weeks, 4 Weeks;Change from baseline in Mental alertness on risingTimepoint: 1 Week, 2 Weeks, 4 Weeks;Change from baseline in nature of waking activitiesTimepoint: 1 Week, 2 Weeks, 4 Weeks;Change from baseline in number and duration of Sleep interruptionsTimepoint: 1 Week, 2 Weeks, 4 Weeks;Change from baseline in quality of sleepTimepoint: 1 Week, 2 Weeks, 4 Weeks;Hamilton Anxiety Scale (HAM-A)Timepoint: 1 Week, 2 Weeks, 4 Weeks;Pittsburgh Sleep Quality Index (PSQI) ScoreTimepoint: Baseline, 1 Week, 2 Weeks, 4 Weeks;Total Sleep Time (TST)- ActigraphyTimepoint: Baseline, 1 Week, 2 Weeks, 4 Weeks