Study the effect of herbal medicine, Sensoril (Aswagandha)in patients with chronic stress
- Conditions
- Health Condition 1: F411- Generalized anxiety disorder
- Registration Number
- CTRI/2019/11/022100
- Lead Sponsor
- atreon Inc Branch Office India
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Age 18 to 60 years, Community dwelling subjects, predominant complaint is anxiety, depression, or sleep disturbances related to chronic stress having Score of 3 or higher on Item 3 of the PSS and Score of 28 or higher on the PSS. This cut off implies an average score of at least 2 for each item. Anxiety, depression, or other symptoms are not a result of exposure to recent, current major life events to which adaptation may occur as a natural event like bereavement or to which adaptation is unlikely cancer or other severe or terminal medical illness. Duration of anxiety, depression, insomnia, or other symptoms related to stress is more than 3 month, this will help to ensure that patients with self limiting stressors are not included, and will help to ensure that patients have failed to cope within 3 months, implying that they will not spontaneously cope, thereafter. Residence within the catchment area of the hospital with reasonable confirmation of feasibility of compliance with study visits. Provision of signed informed consent.
Anticipation of any change in stressors or life events either increase or decrease, across the course of the study. Any clinically significant medical or psychiatric symptoms for which initiation of medication is indicated, subjects with a DSM 5 diagnosis of Generalized Anxiety Disorder and those with a DSM 5 diagnosis of Dysthymia, however, will be eligible for recruitment provided that their Hamilton Anxiety or HAM-A and Hamilton Depression or HAM-D rating scale scores are each below 18. Any personality disorder, any alcohol or substance use disorder, current smoking 10 or more cigarettes per day will be excluded. Suicidal intent at any time during the past 4 weeks, as determined by self report will be excluded. Use of any psychotropic or nutraceuticals medication for more than 1 week during the past month, use of any psychotropic or nutraceuticals drug during the past week, current treatment with psychotherapy will be excluded.Past history of non-response to Withania somnifera will be excluded. Presence of untreated or unstable major medical comorbidity such as diabetes, hypertension, ischemic heart disease and neuropsychiatric disease, in this context, unstable refers to the occurrence of either a medical incident related to the disease or medication dose adjustment related to the disease during the past month will be excluded. Current or past history of any major medical or neuropsychiatric disorder that may confound the clinical picture of stress and the rating of its severity like mood disorder, psychosis, head injury and stroke will be excluded. If female and of childbearing potential, recruitment will be considered only if the patient is not pregnant, as determined by a pregnancy test, and not lactating, and if an undertaking is provided in the informed consent form that the patient will take sufficient contraceptive or other precautions to avoid conception during the treatment period and for at least one month thereafter, will be excluded.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The efficacy of Sensoril prepared from aqueous extract of Withania somnifera will be determined in relation to placebo as a control treatment, across an 8 week period of treatment in community dwelling subjects who seek assistance for mood, sleep, and other psychological and behavioral problems related to stress, anxiety, and depression by questionnaire and biochemical tests. <br/ ><br>Timepoint: From base line to 8 weeks
- Secondary Outcome Measures
Name Time Method To determine whether Sensoril attenuates anxiety or depression or reduces sleep latency and improves sleep efficiency. To determine whether Sensoril attenuates biochemical indices of inflammation and stress like salivary alpha amylase, serum cortisol, ACTH, DHEAS, hs C reactive protein, IL1b, IL6, and TNFa. To determine whether Sensoril is associated with discontinuation symptoms one week after abrupt drug discontinuation. <br/ ><br>Timepoint: 30 months