None listed
Conditions
Interventions
Intervention1: Ashwagandha extract: Two capsules of Ashwagandha Extract 300 mg in the evening orally for 6 weeks
Control Intervention1: Placebo capsules: Two capsules of Placebo 300 mg in the evening
Sponsors
International Institute of Sleep Sciences
Eligibility
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in total score of Restorative Sleep Questionnaire-weekly version (RSQ-W) Change in Actigraphy parameters(Average number of awakenings per hour of sleep, Average total sleep time in one week, Sleep efficiency) Change in the Nocturnal Polysomnogram parameters Change in Quality of life scores using WHOQOL-BREF scale Change in Depression and anxiety scores using Hospital Anxiety and Depression Scale Change in C-reactive protein levels Timepoint: Screening, Day 8, Day 36, Day 50. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Actigraphy parameters(Average number of awakenings per hour of sleep, Average total sleep time in one week, Sleep efficiency) Change in the Nocturnal Polysomnogram parameters Change in Quality of life scores using WHOQOL-BREF scale Change in Depression and anxiety scores using Hospital Anxiety and Depression Scale Change in C-reactive protein levels Timepoint: Screening, Day 1, Day 2, Day 8,Day 36,Day 43 and Day 50. | — |
Countries
India
Contacts
Public ContactDr Nushafreen Irani
Arjuna Natural Extracts Ltd
Outcome results
None listed