Evaluation of the safety and efficacy of Ashwagandha whole plant extract in patients with insomnia.

Recruiting

• Registration Number: CTRI/2022/05/042597
• Lead Sponsor: SamiSabinsa Group Limited

Brief Summary

All eligible patients who meet the Inclusion and Exclusion criteria will be enrolled in the study. All patients of this study will be randomised to either Ashwagandha 500 mg once a day or Placebo of 500mg once a day for a period of 30 days.   2 ml of saliva is taken in the morning (8:00 am) in a fasting state for salivary cortisol. Patient visits will be as follows on Screening Visit- visit 1(Day -5), Baseline -Visit 2 (Day 0), Visit 3 (Day 7)  +/- 3 days; and Visit 4 (Day 30) +/- 5 days.

Telephonic follow-up after 10 days from the last visit to know the Adverse event and overall wellbeing of the patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-06
• Last Update Posted: 2022-05-17

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 86

Inclusion Criteria

• 1.Male and Female participant above 18 to 60 years of age and willing to give written inform Consent.
• 2.Perceived total sleep time of more than 6 hours per night 3.Patient with history of self-reported primary insomnia Or with diagnosis of primary insomnia (as defined by the Diagnostic and Statistical Manual for Mental Disorders-IV [DSM-IV-TR].

Exclusion Criteria

• 1.Female who are pregnant, breast feeding or not willing to use adequate contraception during the course of the study.
• 2.BMI more than or equal to 18.5 or less than or equal to 35 kg/m2 3.Patient with psychiatric illness or concomitant disorder or any other condition that could potentially disturb or have impact on sleep.
• 4.Patients using tobacco products or caffeinated beverages during night awakenings.
• 5.Patient with diagnostic history of serious illness liver, kidney, heart, thyroid or bone marrow.
• 6.Patients on any medication for insomnia.
• 7.Patients with liver function parameters (total bilirubin, conjugated bilirubin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase) more than 2 times upper limit of normal.
• 8.Patients using any sedative hypnotic drugs including benzodiazepines, non-benzodiazepine synthetic drugs, herbal and OTC products.
• 9.Patients worked in night shifts within 5 days of screening or intended to do so during the course of the study.
• 10.Patients with history of alcohol abuse or drugs abuse.
• 11.Patients who were using any other medication that are known to influence sleep but could not be withdrawn.
• 12.Patients undergoing treatment for any other systemic illness.
• 13.Patients who are participated in another investigational drug had been used within three months prior to screening in this study.
• 14.Patients with known allergic reaction to the investigational product.
• 15.Patients who could not be relied upon to comply with the study procedures.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Mean change in the Sleep Condition Indicator (SCI).	1. Day 0, Day 7 and Day 30. | 2. Day 0, Day 7 and Day 30.
2. Mean change in total sleep time	1. Day 0, Day 7 and Day 30. | 2. Day 0, Day 7 and Day 30.

Secondary Outcome Measures

Name	Time	Method
1. Mean change in average sleep latency per night	2. Mean change in average no of night-time awakenings per night.

Trial Locations

Locations (2)

BGS Global Institute of Medical Sciences; 🇮🇳 Bangalore, KARNATAKA, India

Medstar Speciality Hospital; 🇮🇳 Bangalore, KARNATAKA, India

BGS Global Institute of Medical Sciences

🇮🇳Bangalore, KARNATAKA, India

Dr Veena

Principal investigator

9880902005

drveenarm@gmail.com