A Clinical Study To Evaluate The Efficacy And Safety Of Ashwagandha Caplet In Individuals Suffering From Stress And Anxiety Disorders
- Conditions
- Health Condition 1: F411- Generalized anxiety disorder
- Registration Number
- CTRI/2022/06/043464
- Lead Sponsor
- Himalaya Wellness Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1. Male or non-pregnant / non-lactating female subjects between =18 to =69 years of age.
2. Individuals presenting with mild to moderate stress and anxiety disorders as per DSM-V-TR Diagnostic Criteria and fulfilling one or both of the following criteria:
a. Score of 17-24 on the Hamilton – A Scale
b. A score 14-26 on the Perceived Stress Scale (PSS)
As per the ICD 10 they may include like generalized anxiety disorder, panic disorder, social phobia or social anxiety disorder, post traumatic disorder etc.
Post Covid patients who recovered 1 month prior to screening can be enrolled in the study.
3. Body mass index between 16.5 to 30 kg/m2
4. Women of child-bearing potential willing to use an adequate method of contraception to avoid pregnancy throughout the study period
5. Willing to sign inform consent document and abide by the study procedures
1. Subjects with other known Psychiatric or Neurological conditions like major depression, schizophrenia, mental retardation, psychosis, severe case of migraine or other headache, uncontrolled hypertension, or vestibular abnormalities or any other uncontrolled neurological diseases.
2. Have a significant and uncontrolled acute or chronic coexisting illness related to Cardiovascular, Respiratory Gastrointestinal, Immunological, Metabolic, Endocrinology specially Thyroid disorder, Neurological system or any other condition which in the Investigators judgement contraindicate entry into the study.
3.History of taking(within 4 weeks prior to screening) psychoactive medication (anxiolytics, sedatives, hypnotics, anti-psychotics, anti-depressants, anti-convulsant, antihypertensives, centrally acting corticosteroids, opioid pain relievers) hypnotics, narcotic analgesics, antidepressants, anticonvulsants, sedating H1 antihistamines, over-the-counter and prescriptions stimulants, decongestants, melatonin, drugs for oral alkalization, and all other drugs or supplements known to affect sleep cycle. However controlled case of hypertension with stable dosages medication can be enrolled in the study.
4.Subjects with lymphatic congestion during colds and flu, or symptoms of ama.
5.Any dietary supplements that the Investigator believes would interfere with the objectives of the study, pose a safety risk or confound the interpretation of the study results e.g. melatonin, omega-3 dietary supplements.
6.Recent within 4 weeks prior to screening or ongoing systemic antibiotic therapy during the study period.
7.Female patients with PCOD/PCOS
8.Herbal preparations or formulations containing Ashwagandha, ginseng, ginkgo biloba, St. John Wort, Brahmi, kava kava or related herbs.
9.History or present case of Alcohol or drug dependence or Smokers .
10.Self-declared illicit drug users including cannabis and cocaine.
11.Participation in another study with any investigational product within 60 days of screening.
12.Significant laboratory abnormality related to Hematologic or Biochemical parameters, which in opinion of Investigator may interfere in the compliance or interpretation of the study results.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ? Comparison of mean change in Hamilton- A scale score, at the end of 8 weeks between the groups <br/ ><br>? Comparison of mean change in Perceived Stress Scale (PSS) <br/ ><br>score at the end of 8 weeks between the groups.Timepoint: 8 weeks
- Secondary Outcome Measures
Name Time Method ? Comparison of mean change in GHQ (General Health Questionnaire) scoring at the end of 8 weeks between the <br/ ><br>groups. <br/ ><br>? Comparison of Fatigue Assessment Score on the basis of evaluation on Fatigue Assessment Scale (FAS) <br/ ><br>? Proportion withdrawing from trial because of adverse events (tolerability). <br/ ><br>? Safety evaluation through Incidence of adverse events during the study period. <br/ ><br>? Compliance of the subject to the study medication.Timepoint: 8 weeks