CTRI/2018/04/012984CompletedPhase 2
A Randomized, Double blind, Placebo controlled, Multi-centric, Interventional, Prospective Clinical study to Evaluate Efficacy and Safety of Ayumem Capsule in subjects with Stress and Insomnia. - NI
Welex Laboratories Pvt Ltd0 sites61 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 61
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •1.Subjects who perceive themselves to be under stress and having a score of between 14 -24 on the Perceived Stress Scale (PSS).
- •2.Subjects not having any other psychiatric conditions than stress.
- •3.Subjects willing to follow the procedures as per the study protocol and voluntarily sign an informed consent form
Exclusion Criteria
- •1.Subjects suffering from any chronic physical, hormonal or psychiatric illness.
- •2.Subjects using oral or systemic contraceptive medications.
- •3.Subjects with uncontrolled diabetes and hypertension.
- •4.Subjects with substance dependence.
- •5.Chronic alcoholics and Habitual Tobacco chewers.
- •6.Known cases of Severe/Chronic hepatic or renal disease.
- •7.Known subject of any active malignancy.
- •8.Subjects giving history of significant cardiovascular event <12 weeks prior to recruitment.
- •9.Subjects having known chronic, contagious infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV.
- •10.Known subjects of having active metabolic or gastrointestinal diseases that may interfere with nutrient absorption, metabolism, or excretion, excluding diabetes.
- •11.Subjects using any other investigational drug within 1 month prior to recruitment or Subjects currently participating in any other Clinical study.
- •12.Known hypersensitivity to any of the ingredients used in study drug.
- •13.Pregnant and Lactating females.
- •14.Any other condition due to which patients are deemed to be unsuitable by the investigator for reason(s) not specifically started in the exclusion criteria.
Investigators
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