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

An open label, multicentric, prospective, non-randomized, phase-IV post-marketing, surveillance study to evaluate the efficacy and safety of "Zero Tension Tablet" in individuals suffering from mild to moderate stress, anxiety and insomnia disorders - Zero Tension Tablet

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/04/042212

Enrollment

100

Registered

2022-04-27

Start date

Unknown

Completion date

Unknown

Last updated

2022-10-17

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

Conditions

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

Interventions

None listed

Eligibility

Inclusion criteria

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

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, AlzheimerÃ¢â?¬•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 investigatorÃ¢â?¬•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.

Design outcomes

Primary

Measure	Time frame
To compare efficacy of Ã¢â?¬Å?Zero tensionÃ¢â?¬? as compared to baseline for improvement in the signs and symptoms of anxiety, stress and insomnia disorders.Timepoint: Day 1-Day 56	—

Secondary

Measure	Time frame
Improving general wellbeing, safety and compliance of the study drug.Timepoint: Day 1-Day 56	—

Countries

India

Contacts

Public ContactMr Hasan Ali

ALNA Biotech Pvt. Ltd.

vijaykimtata.vk@gmail.com91-9816333352

Outcome results