Clinical study on AshwaDaat® Capsule in subjects with Stress and Insomnia

Phase 2

Completed

• Conditions: Health Condition 1: G470- InsomniaHealth Condition 2: Z733- Stress, not elsewhere classified

• Registration Number: CTRI/2020/11/028937
• Lead Sponsor: ODAAT PHARMA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

1.Subjects who perceive themselves to be under stress and having a score between 14 -24 on the Perceived Stress Scale (PSS)

2.Subjects not having any psychiatric conditions other 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 on treatment for stress and insomnia

3.Subjects using oral or systemic contraceptive medications

4.Subjects with uncontrolled diabetes and hypertension

5.Subjects with substance dependence

6. Chronic alcoholics and Habitual Tobacco chewers.

7.Known cases of Severe/Chronic hepatic or renal disease.

8.Known case of any active malignancy.

9.Subjects giving history of significant cardiovascular event < 12 weeks prior to recruitment.

10.Subjects having known chronic, contagious infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV.

11.Known case of having active metabolic or gastrointestinal diseases that may interfere with nutrient absorption, metabolism, or excretion, excluding diabetes.

12.Subjects using any other investigational drug within 1 month prior to

recruitment or Subjects currently participating in any other Clinical study

13.Known hypersensitivity to any of the ingredients used in study drug

14.Pregnant and Lactating females.

15.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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in stress on perceived stress scale (PSS)Timepoint: Day -3, Day 0, Day 15, Day 30

Secondary Outcome Measures

Name	Time	Method
1.Changes in severity of Insomnia on Insomnia Severity Index <br/ ><br>2.Change in pre and post serum cortisol (morning) level <br/ ><br>3.Change in Quality of Life on GHQ28 Scale <br/ ><br>4.Changes in vitals. <br/ ><br>5.Assessment of occurrence adverse event <br/ ><br>6.Global assessment for overall change by investigator and subject on CGI Scale <br/ ><br>7.Assessment of tolerability of study drug by investigator and subject. <br/ ><br>8.Assessment of safety by assessing safety lab parameters <br/ ><br>Timepoint: Day -3, Day 0, Day 15, Day 30