CTRI/2022/05/042597Recruiting未知
A double-blind, randomized, placebo-controlled comparative study to evaluate the safety and efficacy of Ashwagandha whole plant extract in patients with insomnia
SamiSabinsa Group Limited0 sites0 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- 未知
- Status
- Recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
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- •11.Patients who were using any other medication that are known to influence sleep but could not be withdrawn.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.
Investigators
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