To evaluate safety and efficacy of a botanical containing tablet (CAG-11) in the management of Stress

An open-labeled, single-arm, interventional clinical study to evaluate safety and efficacy of a botanical containing tablet (CAG-11) in the management of Stress

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/10/058467

Enrollment

Registered

2023-10-10

Start date

Unknown

Completion date

Unknown

Last updated

2023-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: F488- Other specified nonpsychotic mental disorders

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1. Men and women aged between 18-50 years, both inclusive. 2. Subjects presenting continuous stress related problems for more than 2 weeks 3. Subjects not under treatment for stress in the last 2 weeks of screening 4. Subjects presenting moderate continuous stress levels basis PSS scale between 14 - 26 5. Able and willing to follow all study related instructions. 6. Must be willing to give written informed consent and comply with the study procedures. 7. Subject’s complete blood count parameters to be within clinically acceptable range by Investigator.

Exclusion criteria

Exclusion criteria: 1. Pregnant and Breast-feeding women will be excluded. 2. On-going treatment on managing stress levels. 3. Severe psychiatric disorders, severe episodes of anxiety disorders, post-traumatic stress disorder 4. Subjects presenting with severe continuous stress levels basis PSS scale (27 – 40) 5. Systemic disorders, who have undergone surgeries, are on medications, endocrinal disorders 6. History of having received any investigational drug or participated in any other clinical trial which ended in the preceding three months 7. Any condition that in the opinion of the investigator does not justify the subject’s inclusion for the study. 8. Subjects with underlying heart conditions, other lifestyle disorders and systemic illness.

Design outcomes

Primary

Measure	Time frame
1)Clinically significant improvement from moderate to mild or no stress as given in PSS.Timepoint: Day 1, Day 14, Day 28 and Day 56	—

Secondary

Measure	Time frame
1)Improvement in morning serum cortisol levels by end of study compared to before treatment. 2)Improvement in overall QoL assess by WHO-5 wellbeing index scale score by end of study compared to before treatment 3)Improvement of resilience assess by Brief Resilience scale (BRS) score by end of study compared to before treatment 4)Change in laboratory safety and clinical parameters by end of study compared to before treatment 5)Incidence of adverse events reported or observed during the study period.Timepoint: Day 1, Day 14, Day 28 and Day 56	—

Measure

Time frame

1)Improvement in morning serum cortisol levels by end of study compared to before treatment. 2)Improvement in overall QoL assess by WHO-5 wellbeing index scale score by end of study compared to before treatment 3)Improvement of resilience assess by Brief Resilience scale (BRS) score by end of study compared to before treatment 4)Change in laboratory safety and clinical parameters by end of study compared to before treatment 5)Incidence of adverse events reported or observed during the study period.Timepoint: Day 1, Day 14, Day 28 and Day 56

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Countries

India

Contacts

Public ContactMr Hasan Ali Ahmed

Xplora Clinical Research Services Pvt. Ltd.

hasan@xplorahealth.com9886012598

Outcome results