A Clinical investigation to Evaluate the Efficacy and Safety of antistress formulation in Managing Anxiety Disorder.

An open clinical trial to evaluate the efficacy of Pankajakasthuri antistress formulation in the management of patients diagnosed with generalized anxiety disorder - nil

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/05/066782

Enrollment

150

Registered

2024-05-06

Start date

Unknown

Completion date

Unknown

Last updated

2024-06-24

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

Conditions

Health Condition 1: F41- Other anxiety disorders

Interventions

None listed

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Efficacy of Pankajakasthuri antistress formulation in Hamilton Anxiety Rating scale parameters, Cortisol and GSR BIOFEEDBACK. Any incidents of adverse events after the administration of Pankajakasthuri antistress formulation Any marked change in safety parameters (like LFT, RFT) measured during the administration of the product. 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.	—

Measure

Time frame

Efficacy of Pankajakasthuri antistress formulation in Hamilton Anxiety Rating scale parameters, Cortisol and GSR BIOFEEDBACK. Any incidents of adverse events after the administration of Pankajakasthuri antistress formulation Any marked change in safety parameters (like LFT, RFT) measured during the administration of the product. 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

Measure	Time frame
Additional therapeutic advantages of Pankajakasthuri antistress formulation Effect of Pankajakasthuri antistress formulation in quality of life Timepoint: Quality of life Assessment will be assessed on 0th day, 30th day, 90th day and 180th day	—

Countries

India

Contacts

Public ContactShan Sasidharan

Pankajakasthuri Herbal Research Foundation

drshan@pkhil.com09188325339

Outcome results