A Clinical investigation to Evaluate the Efficacy and Safety of antistress formulation in Managing Anxiety Disorder.
Phase 2
- Conditions
- Health Condition 1: F41- Other anxiety disorders
- Registration Number
- CTRI/2024/05/066782
- Lead Sponsor
- Pankajakasthuri Herbals India Pvt Ltd P
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1.Patients of either gender in the age group between 18 -60 years
2. Diagnosed as per ICD 10 criteria
3.Patients having Symptoms of GAD
4.Willing to enrol in study by signing Informed consent
Exclusion Criteria
Earlier participation in this study
2.Patients having other systemic diseases not under control
3.Patients who are not willing to sign the informed consent form
4.Patients who are diagnosed with Organic brain syndrome
5.Subjects with un controlled Endocrine disorders
6.Unable to respond properly for questionnaire or when a patient is too severely ill to answer the questions
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy of Pankajakasthuri antistress formulation in Hamilton Anxiety Rating scale parameters, Cortisol and GSR BIOFEEDBACK. <br/ ><br>Any incidents of adverse events after the administration of Pankajakasthuri antistress formulation <br/ ><br>Any marked change in safety parameters (like LFT, RFT) measured during the administration of the product. <br/ ><br>Timepoint: The efficacy parameters including Hamilton anxiety rating scale, S. cortisol and GSR Biofeedback; safety parameters including LFT, RFT will be assessed on Base line, 4th week, 12th week and 24th week.
- Secondary Outcome Measures
Name Time Method Additional therapeutic advantages of Pankajakasthuri antistress formulation <br/ ><br>Effect of Pankajakasthuri antistress formulation in quality of life <br/ ><br>Timepoint: Quality of life Assessment will be assessed on 0th day, 30th day, 90th day and 180th day