Zero Tension Tablet for mild to moderate stress, anxiety and insomnia disorder Study

Phase 4

Completed

• Conditions: Health Condition 1: F40-F48- Anxiety, dissociative, stress-related, somatoform and other nonpsychotic mental disordersHealth Condition 2: F01-F99- Mental, Behavioral and Neurodevelopmental disordersHealth Condition 3: F489- Nonpsychotic mental disorder, unspecifiedHealth Condition 4: F48- Other nonpsychotic mental disorders

• Registration Number: CTRI/2022/04/042212
• Lead Sponsor: ALNA BIOTECH PVTLTD

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-09-20
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 100

Inclusion Criteria

1. Adults in the age of 18-60 years.

2. Subjects with general good health as determined by the investigator.

3. Individuals presenting with mild to moderate stress, anxiety and insomnia disorders and further fulfilling one or both of the following criteria:

a. Score of 17-24 on the Hamilton-A Scale

b. A score 14-26 on the Perceived Stress Scale (PSS)

Exclusion Criteria

1. Individuals who have taken prior medication for stress or anxiety in the last three months.

2. Individuals with comorbid conditions such as thyroid disorders, uncontrolled hypertension and uncontrolled diabetes mellitus.

3. Individuals with mental disorder such as Schizophrenia, Alzheimerââ?¬•s disease etc, except anxiety and insomnia.

4. Individuals with significant and uncontrolled acute or chronic coexisting illness related to cardiovascular, respiratory, gastrointestinal, immunological, metabolic, endocrinology, neurological system or any other condition which in the investigatorââ?¬•s judgement contraindicate entry into the study.

5. History of taking (within 4 weeks prior to screening) psychoactive medication (anxiolytics, sedatives, hypnotics, anti-psychotics, anti-depressants, anticonvulsant, centrally acting corticosteroids, opioid pain relievers) hypnotics, narcotic analgesics, antidepressants, anticonvulsants, sedating H1 antihistamines, over-the-counter and prescriptions stimulants, decongestants, melatonin, drugs for oral alkalization, and all other drugs or supplements known to affect sleep cycle.

6. A known history or present condition of allergies that may require medical attention.

7. History or present case of alcohol or drug dependence (illicit drug users)

8. Present case of smoking and self-declared illicit drug users (including cannabis and cocaine)

9. Individuals suffering from PCOS or PCOD.

10. Subjects not willing to stop the use of another product similar to the test product during study period.

11. Subjects who are pregnant or are planning to get pregnant during the course of the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified