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Clinical Trials/CTRI/2018/04/012984
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

Sponsor
Welex Laboratories Pvt Ltd

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