To check the safety and efficacy of Cread AM on the adult participants with mild stress and anxiety.

A Non Randomized Single Arm Study to Evaluate the Safety and Efficacy of Cread AM an Ayurvedic Formulation to Manage Stress and Anxiety in Adults - NA

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/07/090292

Enrollment

Registered

2025-07-07

Start date

Unknown

Completion date

Unknown

Last updated

2025-11-17

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

Conditions

Health Condition 1: F489- Nonpsychotic mental disorder, unspecified Health Condition 2: F488- Other specified nonpsychotic mental disorders

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male and female adults aged between 18 and 60 years. 2. Individuals presenting (at least 2 weeks) with mild to moderate stress and anxiety disorders as per DSM-V-TR Diagnostic Criteria and further fulfilling the following criteria: A score 10-26 on the Perceived Stress Scale (PSS) 3. Women of child-bearing potential willing to use an adequate method of contraception to avoid pregnancy throughout the study period 4. Willing to sign inform consent document and abide by the study procedures.

Exclusion criteria

Exclusion criteria: 1. Chronic alcoholics consuming more than 2 standard pegs per day. 2. Subjects with known hypertension or other cardiovascular diseases diseases. However controlled case of hypertension with stable dosages medication can be enrolled in the study 3. Subjects with a history of liver diseases, kidney diseases, psychiatric conditions, epilepsy, or any other relevant medical conditions. 4. Subjects unwilling or unable to comply with the study protocol. 5. Subjects currently participating in another clinical trial or who have received any investigational product (IP) within 90 days prior to Visit 1 (Screening). 6. Subjects currently taking medications other than oral contraceptives. 7. Subjects on hepatotoxic medications, such as antitubercular medications, antiviral medications, or paracetamol. 8. Pregnant women, those attempting to conceive, or lactating women. 9. Individu als with acute narrow angle glaucoma, prostate hypertrophy, or any cardiovascular, endocrine, renal, or other chronic diseases that could influence stress or anxiety or restrict normal daily functioning. 10. Individuals with any diagnosable mental health disor der in the past 6 months or those currently taking psychotropic medications or other herbal preparations.

Design outcomes

Primary

Measure	Time frame
1) To evaluate the efficacy of Cread AM in improving Anxiety in Adults as measured by General Anxiety Disorder 7 (GAD 7) scale from Screening to the end of the study (assessments at Day 1 and Day 56). 2) To assess the efficacy of Cread AM in in managing stress levels in adults as measured by Perceived Stress Scale (PSS) scale from Screening to the end of the study (assessments at Day 1 and Day 56).Timepoint: Visit-1(Day-1), Visit-2(Telephonic), Visit-3(Day-56)	—

Measure

Time frame

1) To evaluate the efficacy of Cread AM in improving Anxiety in Adults as measured by General Anxiety Disorder 7 (GAD 7) scale from Screening to the end of the study (assessments at Day 1 and Day 56). 2) To assess the efficacy of Cread AM in in managing stress levels in adults as measured by Perceived Stress Scale (PSS) scale from Screening to the end of the study (assessments at Day 1 and Day 56).Timepoint: Visit-1(Day-1), Visit-2(Telephonic), Visit-3(Day-56)

—

Secondary

Measure	Time frame
1) To evaluate the impact of Cread AM on stress using Serum Cortisol levels at Day 1 and Day 56 2) To monitor safety parameters at Day 1 to Day 56 for any adverse events or clinically significant findings 3) To assess the safety and tolerability of Cread AM throughout the study period by evaluating clinical and laboratory parameters. Measurements will be conducted at Screening and End of visit .Timepoint: Visit-1(Day-1), Visit-2(Telephonic), Visit-3(Day-56)	—

Measure

Time frame

1) To evaluate the impact of Cread AM on stress using Serum Cortisol levels at Day 1 and Day 56 2) To monitor safety parameters at Day 1 to Day 56 for any adverse events or clinically significant findings 3) To assess the safety and tolerability of Cread AM throughout the study period by evaluating clinical and laboratory parameters. Measurements will be conducted at Screening and End of visit .Timepoint: Visit-1(Day-1), Visit-2(Telephonic), Visit-3(Day-56)

—

Countries

India

Contacts

Public ContactMr Manik Chaudari

Xplora Clinical Research Services Pvt Ltd

hasan@xplorahealth.com9886012598

Outcome results