Clinical trial on sleep disorders

Phase 3

Completed

• Conditions: Insomnia,

• Registration Number: CTRI/2023/02/049470
• Lead Sponsor: CSIR Indian Institute of Integrative Medicine

Brief Summary

The objective of this study is to validate the safety & efficacy of oral administration of Ashwagandha capsule (comprising extract A and Extract B) for sleep disorder (Insomnia) in otherwise healthy volunteersInsomnia, also known as sleeplessness, is a sleep disorder in which people have trouble sleeping. They may have difficulty falling asleep, or staying asleep as long as desired. Insomnia is typically followed by daytime sleepiness, low energy, irritability, and a depressed mood. It may result in an increased risk of motor vehicle collisions, as well as problems focusing and learning.



Withania somnifera, known commonly as Ashwagandha or winter cherry, is an evergreen shrub in the Solanaceae or nightshade family that grows in India, the Middle East, and parts of Africa.

Several other species in the genus Withania are morphologically similar. It has been traditionally known since ancient times in India for its numerous beneficial health activities. WS is one of the most important herbs in Ayurveda, which has been used for >3000 years in stress management, energy elevation and improving cognitive health and to lower inflammation, blood sugar levels, cortisol, anxiety, and depression. The plant is an erect, grayish, evergreen shrub with long tuberous roots, short stems, ovate and petiolate leaves, and greenish axillary and bisexual flowers. The leaves, roots, stems and flowers bear medicinal values with 29 common metabolites derived from the leaves

and root extracts. To date, this medicinal plant has been found to have anti-epileptic, antiinflammatory, anti-arthritic, anti-depressant, anti-coagulant, anti-oxidant, anti-diabetic, anti-pyretic efficacies along with palliative effects such as analgesic, rejuvenating, regenerating and growthpromoting effects.

Detailed Description

Not available

Study Timeline

• Study Completion: 2023-03-16
• Last Update Posted: 2023-03-31
• Study Start: 2023-10-02

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Male volunteers who are 18 or older to 72 years.
• Insomnia Severity Index 10-14 3.
• Meet diagnostic criteria for Insomnia Disorder per DSM-5 4.
• Willing and able to sign Informed consent form 5.
• Not planning on moving away from the area for the subsequent 12 weeks 6.Subjects should not have Milk during the study.

Exclusion Criteria

• Night shift workers and individuals who nap 3 or more times per week over the preceding month 2.
• Consumption of caffeine beverages tea, coffee, or cola comprising usually more than 5 cups or glasses per day 3.
• Participation in another trial for insomnia 4.
• Subjects having milk on regular basis.
• Persons who are unable to participate for the entire duration of the study, or in the opinion of the investigators, are likely to be noncompliant with the obligations inherent in the trial participation 6.
• Persons self describing with severe anxiety or severe depression BDI score of 29 or higher or severe anxiety BAI score of 36 or higher 7.
• Persons with a history of epilepsy, seizures, or dementia any significant, severe or unstable, acute progressive medical or surgical condition stroke or head injury 8.
• Current alcohol or substance abuse/dependence must have greater than90 days of sobriety 9.
• Presence of other neurological disorders Ex multiple sclerosis, Parkinsons Disease 10.
• Presence of an untreated or unstable medical or psychiatric comorbid condition ex major depressive disorder or psychotic disorder requiring admission within the last two years People using psychotropic medication hypnotic or sedative medications may be included if they are on a stable dosage for the last 2 months prior to the study, if the dose remains stable throughout the study, and if the medication is judged to not interfere with the study outcomes.
• Currently on medications known to produce insomnia ex.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
2. Improvement of insomnia outcome is measured by Insomnia Severity Index (ISI), selfreported	Day 0 & Day 8.
questionnaire, actigraphy, polysmonography on Day 0 & Day 8.	Day 0 & Day 8.
1. The primary end point is completion of 1-week treatment sessions on Day 0 and Day 8 with	Day 0 & Day 8.
cross over assessment.	Day 0 & Day 8.

Secondary Outcome Measures

Name	Time	Method
The Secondary end point is improvement in biomarker values from Day 0 to Day 8	Day 0 & Day 8.

Trial Locations

Locations (1)

Medstar Speciality Hospital; 🇮🇳 Bangalore, KARNATAKA, India

Medstar Speciality Hospital

🇮🇳Bangalore, KARNATAKA, India

DrReginald Varadarajulu

Principal investigator

9880101778

varadarajuludr.medstar@gmail.com