Skip to content

Role of ALERT Capsule in Generalized Anxiety Disorder

Efficacy and Safety of ALERT Capsule in the Managment of Generalized Anxiety Disorder-An Open Label Clinical Study

Status
Recruiting
Phases
Phase 2Phase 3
Study type
Observational
Source
CTRI
Registry ID
CTRI/2017/09/009774
Enrollment
60
Registered
2017-09-14
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- Generalized Anxiety Disorder (GAD)as per DSM V criteria

Interventions

Intervention1: ALERT Capsules: It contains Celastrus paniculatus (Jyotishmati) Seed oil, and Cow Ghee, processed with Acorus calamus (Vaj) Rhizome, Convolvulus pluricaulis (Shankhapushpi) Whole plant,

Sponsors

Vasu Research Centre VRC A Division of VASU Health Care Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: (1) Patients (Male & Female) between the age group of 18 and 60 years and willing to give consent to participate in the study. (2) Patients having Generalized Anxiety Disorder 7 (GAD-7) score >= 10 (3) Patients having Hamilton Anxiety Rating Score (HAM-A) >= 11 (4) Patients suffering from psycho- physiological insomnia especially due to anxiety.

Exclusion criteria

Exclusion criteria: (1) Patients below 18 years and above 60 years (2) Patients with Hamilton Depression Rating Scale score >13 (3) Patients suffering from any serious liver, kidney and cardiac diseases. (4) Patients having history of any genetic disorders (5) Patients on hypnotic medicine or other drugs which known to cause drowsiness. (6) Lactating & pregnant women (7) Patients on any Psychotropic or Nuerotrophic drugs 4 weeks prior to the study

Design outcomes

Primary

MeasureTime frame
Primary outcomes will be effect of drug on subjective and objective parametersTimepoint: baseline, 15th, 30th, 45th & 60th day

Secondary

MeasureTime frame
Assessment of drug safety and patientâ??s complianceTimepoint: base line, 15th day, 30th day, 45th day, 60th day

Countries

India

Contacts

Public ContactDr Basavaraj R Tubaki

KLEU BMK Ayurveda Mahavidyalaya

ayurbasavaraj@gmail.com09448634660

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026