CTRI/2017/02/007801CompletedPhase 2
A Prospective, Randomized, Double Blind, Placebo Controlled Study to Evaluate the Effects of Ashwagandha (Withania somnifera) Extract on Non-Restorative Sleep
International Institute of Sleep Sciences0 sites150 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 150
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •With age of at least 18 years to 65 years
- •RSQ-W total score less than or equal to 50
- •Have not taken any hypnotic medicine or Ashwagandha within last 1 year
- •Able to communicate and read in English
- •Women of child-bearing potential (refer to appendix for definition) willing to use an adequate method of contraception to avoid pregnancy throughout the study period
- •Willing to provide written informed consent
Exclusion Criteria
- •Medical history of Ischemic Heart Disease, Valvular Heart Disease, Pacemakers, respiratory disorders, seizure disorders
- •Suffering from severe intrinsic sleep related disorders such as severe sleep apnea (STOP BANG questionnaire score greater than 5), moderate to severe restless leg syndrome (RLS), Narcolepsy
- •Suffering from severe grade untreated depression (Score of 15 or more for Anxiety or Depression when measured with Hospital Anxiety and Depression Scale)
- •Women who are pregnant or nursing.
- •Women with a positive pregnancy test on enrollment or 48 hours prior to study intervention
- •If the subjects required to take or continues taking any disallowed medication, prescription medication, herbal treatment or over-the counter medication, including anxiolytics, central nervous system active drugs, hypnotics, narcotic analgesics, anti-inflammatory agents, antidepressants, proton pump inhibitors, antacids, beta blockers, anticonvulsants, St Johns Wort, sedating H1 antihistamines, Kava-kava, systemic steroids, Ginkgo biloba, respiratory stimulants, over the counter
- •and prescriptions stimulants, decongestants, over-the-counter and prescription diet aids, antipsychotics, melatonin, drugs for oral alkalinization and all other drugs or supplements known to affect sleep orwake
- •History of drug addiction or drug abuse within the past 12 months
- •History of alcohol abuse (regularly consumes more than 2 alcoholic drinks per day) within the past 12 months
- •Patients with hepatic impairment (SGOT or SGPT levels greater than 3 Upper Limit of Normal (ULN)) or renal impairment (serum creatinine greaterthan or equal to 2.0 mg/dl).
- •Patients with any other severe systemic illness and in the opinion of the investigator would be noncompliant with the visit schedule or study procedures.
- •Patients with known history of hypersensitivity to Ashwagandha or any product containing Ashwagandha extract
- •Patients with any other serious concurrent illness or malignancy.
- •Participation in another clinical trial in the past 12 months
- •Any other factor which the investigator feel that can affect the findings of the study
Investigators
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